56 Drug Development jobs in the United States
Director of Research Development (7399U) - 63510
Posted 4 days ago
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Director of Research Development (7399U) - 63510 About Berkeley
At the University of California, Berkeley, we are committed to creating a community that fosters equity of experience and opportunity, and ensures that students, faculty, and staff of all backgrounds feel safe, welcome and included. Our culture of openness, freedom and belonging make it a special place for students, faculty and staff.
The University of California, Berkeley, is one of the world's leading institutions of higher education, distinguished by its combination of internationally recognized academic and research excellence; the transformative opportunity it provides to a large and diverse student body; its public mission and commitment to equity and social justice; and its roots in the California experience, animated by such values as innovation, questioning the status quo, and respect for the environment and nature. Since its founding in 1868, Berkeley has fueled a perpetual renaissance, generating unparalleled intellectual, economic and social value in California, the United States and the world.
We are looking for equity-minded applicants who represent the full diversity of California and who demonstrate a sensitivity to and understanding of the diverse academic, socioeconomic, cultural, disability, gender identity, sexual orientation, and ethnic backgrounds present in our community. When you join the team at Berkeley, you can expect to be part of an inclusive, innovative and equity-focused community that approaches higher education as a matter of social justice that requires broad collaboration among faculty, staff, students and community partners. In deciding whether to apply for a position at Berkeley, you are strongly encouraged to consider whether your values align with our Guiding Values and Principles , our Principles of Community , and our Strategic Plan .
At UC Berkeley, we believe that learning is a fundamental part of working, and our goal is for everyone on the Berkeley campus to feel supported and equipped to realize their full potential. We actively support this by providing all of our staff employees with at least 80 hours (10 days) of paid time per year to engage in professional development activities. To find out more about how you can grow your career at UC Berkeley, visit grow.berkeley.edu .
Departmental Overview
The Berkeley School of Education (BSE) is one of the nation's top-ranked schools of education, offering unparalleled scholarship and professional training that prepares future leaders of education policy, practice, and research. With one of the most diverse faculty and student bodies at UC Berkeley, in a community rooted in equity and social justice, the students and faculty of the BSE are joined by their shared commitment to understanding and improving the complex world of education. A central mission of the BSE is to improve teaching and learning for all students in our schools by preparing the next generation of teachers, administrators, educational researchers, and school psychologists in exemplary academic and professional preparation programs, with an emphasis on working with diverse students in urban settings. BSE graduates make a global impact as researchers, professional educators, leaders, and innovators.
Position Summary
Reporting to the Associate Dean of Research, the Director of Research Development develops and oversees the School's research portfolio.
The position will work in coordination with the Assistant Dean of Development and External Relations in order to align and uplift the priorities of the School.
Application Review Date
The First Review Date for this job is: 01/26/2024.
Responsibilities
Strategic Research Advancement
- Collaborate with faculty to identify areas of institutional research priorities.
- Provide strategic planning support to the Dean's Office.
- Assist with sponsor site visits.
Communication of Research and Research Opportunities
- Raise profile of BSE strengths that add to visibility and impact with external funding sources.
- Develop regular communications about new funding opportunities for BSE faculty and students.
- Conduct grant writing workshops.
Enhancement of Collaboration
- Convene and coordinate multi-disciplinary interest groups.
- Catalyze new cross-disciplinary research initiatives.
- Develop and/or coordinate resources and tools to promote collaboration.
- Maintain faculty expertise database and other collaboration tools.
- Facilitate collaborations between investigators at UC Berkeley and other institutes.
Proposal Development & Support Functions
- Assist faculty applying for new research funding opportunities, with a particular emphasis on supporting junior faculty, training grants, and complex multi-faculty proposals such as program project and center grants.
- Provide proposal development support including grant writing, editing, and budget development.
- Liaison with funding agencies during proposal development process.
- Support faculty to ensure smooth post-award launch of newly funded grants and contracts.
- Maintain a file of successful proposals.
Required Qualifications
- Knowledge of and/or can quickly learn UC Berkeley, including its mission, vision, goals, policies, and infrastructure; strong knowledge of issues in higher education.
- Experience in grant proposal development with government agencies and private philanthropies.
- Excellent written, verbal, interpersonal communications, active listening, and political acumen skills.
- Excellent analytical, critical thinking, project management, and problem recognition, avoidance, and resolution skills.
- Bachelor's degree in related area and/or equivalent experience/training.
Preferred Qualifications
- Master's degree in education, grant writing, and or training and/or equivalent experience/training.
- Demonstrated knowledge of the K-16+ education landscape and commitment to excellence and equity in public education.
Salary & Benefits
This is a 3yr, full-time (40 hours/week), contract appointment, eligible for UC benefits with the possibility of extension with continued funding. This is a monthly paid, exempt position.
For information on the comprehensive benefits package offered by the University, please visit the University of California's Compensation & Benefits website.
Under California law, the University of California, Berkeley is required to provide a reasonable estimate of the compensation range for this role and should not offer a salary outside of the range posted in this job announcement. This range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, analysis of internal equity, and other business and organizational needs. It is not typical for an individual to be offered a salary at or near the top of the range for a position. Salary offers are determined based on final candidate qualifications and experience.
The budgeted salary or hourly range that the University reasonably expects to pay for this position is $85,800.00 - $158,200.00.
How to Apply
- To apply, please submit your resume and cover letter.
Other Information
- This is not a visa opportunity.
Conviction History Background
This is a designated position requiring fingerprinting and a background check due to the nature of the job responsibilities. Berkeley does hire people with conviction histories and reviews information received in the context of the job responsibilities. The University reserves the right to make employment contingent upon successful completion of the background check.
Equal Employment Opportunity
The University of California is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. For more information about your rights as an applicant, please see the U.S. Equal Employment Opportunity Commission poster.
For the complete University of California nondiscrimination and affirmative action policy, please see the University of California Discrimination, Harassment, and Affirmative Action in the Workplace policy.
To apply, visit
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Director/Sr. Director, Assay Research & Development
Posted 4 days ago
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Scale Biosciences, Inc. (“ScaleBio”) is an early-stage life sciences technology and tools company developing advanced single-cell solutions based upon the Company's highly parallelized way to barcode cells which allows for exponential scalability. Our mission is to democratize scalable, easy-to-adopt, extensible, cost-effective single-cell applications across a broad range of systems and sample types within the Life Sciences community.
At ScaleBio we have a shared mission built upon a demonstrated technology with long term investment commitments. We are seeking team members that have a passion for developing technologies that benefit the broader researcher community in the discovery of human biology. Such individuals should also have a strong interest in single-cell sequencing as a disruptive and enabling technology.
Scale Biosciences is looking for a driven scientific leader as our Director/Sr. Director of Assay Research and Development reporting into the CEO with research and assay product development functions. The Director of Assay R&D will be a critical part of the leadership team innovating, building, and delivering a pipeline of best-in-class single cell and multi-omics solutions. The Director/Sr. Director of Assay R&D will bring scientific expertise, execution, accountability, and leadership skills to oversee the development of new products, technologies, and solutions in a fast-paced early-stage environment. The Ideal candidate will have proven track record in leading teams to innovate and develop products in the single cell product portfolio space and will have strong technical expertise in cell and molecular biology, NGS, assay development, product development, and single cell technologies and relevant applications in genomics and multi-omics to build products that meet customer needs.
In this role you will influence products development, process and services with knowledge of customer needs, market intelligence, industry advancements and provide and foster innovative solutions to solve problems, leveraging cross-functional teams. It is required that this is an on-site role in San Diego, CA.
Key Responsibilities
- Develop research and development technology roadmaps for novel single cell assay technologies for next-generation sequencing with a focus on single cell RNA profiling and multi-omics.
- Define product concepts and translate customer requirements into products.
- Establish, execute, and drive R&D strategies and goals to meet corporate objectives.
- Work with your team to invent and implement best in class QC methods for reagents and consumables.
- Develop best in class workflow and consumables to meet customer needs.
- Drive development efforts for fast efficient feasibility, development, and product launch.
- Drive efficient technology transfer of products into MFG in partnership with Life Cycle Management.
- Know and institute best practices for research and product development.
- Leverage project management, strategic planning, budgeting, and resource management to keep new product introductions and on market products on track.
- Maintain an awareness of the competitive landscape and identify emerging opportunities to gain a competitive edge.
- Showcase Scale’s capabilities at conferences through presentations and posters and with KOLs to build relationships with external partners and to validate technology.
- Drive products according to the PDP process.
- Lead biology innovation by partnering with marketing and executive staff to identify key areas of innovation, build scientific technical strategies to test POC for new products and lead scientists to deliver on POC.
- Build, lead, mentor a team of scientists to an elevated level of productivity while improving the skills and knowledge.
- Be a hands-on leader that sets clear expectations, guide team members and manage performance by providing feedback, guidance/teaching, and development opportunities.
- Ensure effective interaction and communication in alignment with the leadership team.
- Manages team and deliverables to meet timelines and quality requirements.
- Communicate strategy and progress to executive management.
- A proven scientific leader with a Ph.D. in Chemistry/Biology/Biochemistry/Cell Biology.
- 15+ years of life sciences R&D experience.
- Single Cell experience and expertise a strong plus.
- Demonstrated expertise and a strong track record of success in advancing programs from concept through product launch/transfer to manufacturing.
- Domain expertise in NGS, single cell technologies, epigenetics, genomics, proteomics.
- Well-rounded skill set including project management, strategic planning, budgeting, and team leadership.
- A highly engaged, self-starter who is creative, proactive, innovative, and communicative and possesses both a collaborative and goal/results-oriented style.
- A track record of effectively communicating scientific concepts and strategies, including publication records in top-tier, peer-reviewed journals.
- Excellent leadership capabilities with experience successfully building, guiding and motivating teams.
Base Salary Range - $200,000 - $50,000 USD
ScaleBio provides competitive compensation, health and dental benefits, 401K retirement saving plan, state of the art laboratory facilities, and an exciting and innovative culture with the opportunity to enable a novel single cell technology. To learn more please visit our website . ScaleBio is an equal opportunity employer committed to hiring a diverse and inclusive workforce.
Any and all communications regarding job openings will be communicated by a email address Seniority level
- Seniority level Director
- Employment type Full-time
- Job function Research, Analyst, and Information Technology
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#J-18808-LjbffrDirector/Senior Director, Drug Product Development and Manufacturing (Biologics) Waltham, Massa[...]
Posted 2 days ago
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Waltham, Massachusetts, United States
About Us:
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025. For more information, visit
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Director/Senior Director, Drug Product Development and Manufacturing (Biologics)
Location: Hybrid – Waltham, MA. Candidates will be required to be in-office3 days/week.
Role Overview:
We are seeking an experienced and motivated candidate to manage aseptic drug product development and manufacturing in support of early-to-late-stage manufacturing campaigns. In this role, you will be responsible for drug product process development, technology transfer and manufacturing campaigns at the external CDMO partners. You are an ideal candidate for this role if you have experience with drug product process development, aseptic unit operations, and relevant fill finish equipment utilized for biologics manufacturing. In this role, you will have the opportunity to foster strong collaboration, communication, and problem solving to meet key program and corporate objectives. This is a highly visible role and a pivotal addition to our growing organization where you will play an integral role in supporting multiple campaigns in support of generating supplies for clinical trials across US, Canada and EU.
Key Responsibilities:
- Lead liquid drug product process development, technology transfer, and GMP aseptic manufacturing at external CDMO partners
- Serve as an aseptic fill finish subject matter expert and support manufacturing process readiness, sampling plans, and in-process control strategy for drug products in vials and pre-filled syringes
- Liaise with drug product formulation and analytical SMEs to develop robust formulations, processes, methods and unit operations in support of GMP manufacturing of high concentration biologic drug products
- Lead and support gap analysis, equipment and raw material risk assessment, filter validation studies, in-use compatibility analysis, transportation, and E&L assessment in a phase appropriate manner
- Serve as person-in-plant (PIP) during drug product manufacturing campaigns
- Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot release, retests, in-process sampling plans, stability protocols/reports, retains, change controls, deviations, OOS/OOT investigations, CAPAs and campaign reports
- Ensure stakeholders such as analytical, formulation, clinical supply chain, quality and PM teams are aligned with overall drug product timelines
- Facilitate critical cross functional decisions within the CMC team while keeping program level stakeholders informed at regular interval
- Collaborate with drug substance manufacturing and clinical supply chain stakeholders ensuring robust clinical supply forecasts
- Develop road map for late-stage process development, process characterization, and PPQ campaigns
- Assist in the diligence process to select clinical and commercial CDMO vendors
- Track internal and external manufacturing deliverables and adapt to changing priorities keeping corporate CMC objectives at the forefront
- Foster a culture of collaboration, communication, critical thinking, innovation, and continuous improvement
- 20-25% travel in support of diligence and campaign execution at CDMOs
Qualifications:
- Master’s or a PhD in a scientific discipline with 10-15 years of relevant experience in aseptic drug product development and manufacturing of biologics
- Must have prior experience managing drug product development and GMP manufacturing in vials and pre-filled syringes
- Exposure to supporting or leading device development (pre-filled syringes and auto-injectors) is a plus
- Significant experience developing robust unit operations towards large scale drug product manufacturing campaigns
- Experience with liquid formulation studies, process development, container closure compatibility studies, device functionality studies and QTPP development
- In-depth knowledge of aseptic regulations required to manage multi country regulatory filings
- Demonstrated track record of successful tech transfers to commercial CDMOs with an eye towards late stage and commercial launch
- Strong scientific skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets
- Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
- Must have a creative and strategic attitude with the ability to work in a fast-paced environment
- Strong sense of urgency and ability to deliver in a highly fast paced environment
Compensation:
- An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
- The anticipated salary range for candidates, who will work in Waltham, MA, is $05,000 to 275,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.
We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.
Salary Range for the Role
205,000 - 275,000 USD
What We Offer:
- A chance to be part of a vibrant small-company culture where your work can directly impact bringing new medicines to patients.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
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#J-18808-LjbffrDirector/Sr. Director, Assay Research & Development
Posted 1 day ago
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Scale Biosciences, Inc. (“ScaleBio”) is an early-stage life sciences technology and tools company developing advanced single-cell solutions based upon the Company's highly parallelized way to barcode cells which allows for exponential scalability. Our mission is to democratize scalable, easy-to-adopt, extensible, cost-effective single-cell applications across a broad range of systems and sample types within the Life Sciences community.
At ScaleBio we have a shared mission built upon a demonstrated technology with long term investment commitments. We are seeking team members that have a passion for developing technologies that benefit the broader researcher community in the discovery of human biology. Such individuals should also have a strong interest in single-cell sequencing as a disruptive and enabling technology.
Scale Biosciences is looking for a driven scientific leader as our Director/Sr. Director of Assay Research and Development reporting into the CEO with research and assay product development functions. The Director of Assay R&D will be a critical part of the leadership team innovating, building, and delivering a pipeline of best-in-class single cell and multi-omics solutions. The Director/Sr. Director of Assay R&D will bring scientific expertise, execution, accountability, and leadership skills to oversee the development of new products, technologies, and solutions in a fast-paced early-stage environment. The Ideal candidate will have proven track record in leading teams to innovate and develop products in the single cell product portfolio space and will have strong technical expertise in cell and molecular biology, NGS, assay development, product development, and single cell technologies and relevant applications in genomics and multi-omics to build products that meet customer needs.
In this role you will influence products development, process and services with knowledge of customer needs, market intelligence, industry advancements and provide and foster innovative solutions to solve problems, leveraging cross-functional teams. It is required that this is an on-site role in San Diego, CA.
Key Responsibilities:- Develop research and development technology roadmaps for novel single cell assay technologies for next-generation sequencing with a focus on single cell RNA profiling and multi-omics.
- Define product concepts and translate customer requirements into products.
- Establish, execute, and drive R&D strategies and goals to meet corporate objectives.
- Work with your team to invent and implement best in class QC methods for reagents and consumables.
- Develop best in class workflow and consumables to meet customer needs.
- Drive development efforts for fast efficient feasibility, development, and product launch.
- Drive efficient technology transfer of products into MFG in partnership with Life Cycle Management.
- Know and institute best practices for research and product development.
- Leverage project management, strategic planning, budgeting, and resource management to keep new product introductions and on market products on track.
- Maintain an awareness of the competitive landscape and identify emerging opportunities to gain a competitive edge.
- Showcase Scale’s capabilities at conferences through presentations and posters and with KOLs to build relationships with external partners and to validate technology.
- Drive products according to the PDP process.
- Lead biology innovation by partnering with marketing and executive staff to identify key areas of innovation, build scientific technical strategies to test POC for new products and lead scientists to deliver on POC.
- Build, lead, mentor a team of scientists to an elevated level of productivity while improving the skills and knowledge.
- Be a hands-on leader that sets clear expectations, guide team members and manage performance by providing feedback, guidance/teaching, and development opportunities.
- Ensure effective interaction and communication in alignment with the leadership team.
- Manages team and deliverables to meet timelines and quality requirements.
- Communicate strategy and progress to executive management.
- A proven scientific leader with a Ph.D. in Chemistry/Biology/Biochemistry/Cell Biology.
- 15+ years of life sciences R&D experience.
- Single Cell experience and expertise a strong plus.
- Demonstrated expertise and a strong track record of success in advancing programs from concept through product launch/transfer to manufacturing.
- Domain expertise in NGS, single cell technologies, epigenetics, genomics, proteomics.
- Well-rounded skill set including project management, strategic planning, budgeting, and team leadership.
- A highly engaged, self-starter who is creative, proactive, innovative, and communicative and possesses both a collaborative and goal/results-oriented style.
- A track record of effectively communicating scientific concepts and strategies, including publication records in top-tier, peer-reviewed journals.
- Excellent leadership capabilities with experience successfully building, guiding and motivating teams.
Below is the salary range for this full time position. The actual base pay will depend on several factors unique to each candidate, including one’s skills, qualifications, and experience.
Base Salary Range - $200,000 - $250,000 USD
ScaleBio provides competitive compensation, health and dental benefits, 401K retirement saving plan, state of the art laboratory facilities, and an exciting and innovative culture with the opportunity to enable a novel single cell technology. To learn more please visit our website . ScaleBio is an equal opportunity employer committed to hiring a diverse and inclusive workforce.
Any and all communications regarding job openings will be communicated by a email address
#J-18808-LjbffrScientist III/Principal Scientist - Drug Product Development
Posted today
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Job Description
Company Overview
Salubris Biotherapeutics, Inc. (or SalubrisBio) is a science-driven biotechnology company dedicated to the discovery and global development of novel antibody therapeutics for the treatment of cancer, cardiovascular and metabolic diseases. We strive to develop novel therapeutic molecules that provide clinically meaningful improvements in disease burden and quality of life to patients with significant medical needs.
Role Summary
We are seeking a highly motivated Scientist III/Principal Scientist - Drug Product Development with a strong passion for advancing biopharmaceutical therapies to benefit patients. As a key member of our CMC team, you will collaborate on a wide range of activities, including biologics formulation development in house and drug product process development, optimization and characterization, and validation (PPQ), and drug product manufacturing at CDMOs, pre-clinical and clinical study support, and regulatory submissions. You will play a key role in formulation and DP process development, and drug product manufacturing, ensuring the timely progress toward critical milestones from early development to commercialization of the pipeline programs.
The ideal candidate thrives in a fast-paced, dynamic environment, with strong multitasking abilities, self-motivation, and initiative
Responsibilities
- Lead biologics formulation, drug product (DP) process development and manufacturing at CDMOs, including Fill/Finish processes, for novel biotherapeutics during different clinical stages.
- Act as a subject matter expert (SME) in developing stable, robust formulations for clinical-stage biotherapeutics, including bispecific antibodies and antibody-drug conjugates (ADCs)
- Design, execute, and evaluate formulations through various stability studies (e.g., thermal, conformational, solubility, and photostability).
- Lead drug product process development, optimization, and characterization from early to late-stage stages of clinical development.
- Serve as the liaison to the DP CDMOs and track progress on different activities in collaboration with the CDMOs.
- Lead drug product process validation activities, including process validation master plan, process performance qualification (PPQ) readiness, and execution.
- Perform analytical testing (SEC, DLS/SLS, Osmolality, MFI, etc) for formulation development in-house as needed.
- Oversee the selection of DP containers and packaging material, coordinate DP Fill/Finish processes with CDMOs, and manage bulk shipment and labelling as needed for clinical supplies.
- Ensure GMP compliance during DP Fill/Finish at CDMOs, including person-in-plant (PiP), review of batch records, SOPs, and technical reports. Travel requirements for the role is 10-20%.
- Support DP CDMO and third-party logistics selection and oversight activities required for the development and manufacturing of the pipeline programs.
- Lead compatibility studies of clinical administration components, collaborating closely with analytical and clinical teams
- Collaborate effectively with internal teams (e.g., downstream purification, analytical, and clinical) and external partners.
- Contribute to regulatory filings by preparing and reviewing technical reports and addressing any related technical inquiries.
- Participate in day-to-day lab management, including ordering reagents and maintaining equipment.
- Engage in scientific discussions, prepare technical reports, present findings, and ensure adherence to project timelines.
Qualifications
- MS/PhD in Biochemistry, Biophysics, Chemical Engineering, or related field with a minimum of 8 years of biotech industry experience in early to late-stage formulation, DP process development, and GMP DP Fill/Finish manufacturing at CDMOs.
- Hands-on expertise in formulation and DP process development methodologies, including Design of Experiments (DOE) and statistical approaches.
- Experience in leading late-stage activities, including process characterization and PPQ preparation activities, working with CDMOs is highly preferred.
- Strong technical skills in analytical techniques, such as DLS, SLS, Nano DSF, MFI, HIAC, FT-IR, and CD, including troubleshooting for testing failure or instrument failure, are advantageous.
- Solid understanding of cGMP regulation related to biotherapeutic drug product development and DP Fill/Finish manufacturing.
- Experience authoring IND, IMPD, and/or BLA/MAA sections is preferred.
- Excellent communication skills in verbal and written, and multitasking abilities, with keen attention to detail.
- Self-driven and eager to collaborate while contributing to team goals in a small, dynamic company environment.
Senior Scientist, Analytical Research & Development
Posted today
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Job Description
Who We Are:
At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.
Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.
Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.
Role Overview:
The Sr. Scientist is responsible for the implementation, development, and validation of analytical test methods in support of process research, and cGMP production with emphasis on development of LC, GC, GC-MS and LC/MS, ELISA, SEC-MALS, CE-SDS, cIEF, etc) methods for small molecules, ADCs, Oligonucleotides and Peptides Major support functions include sample analysis by various analytical techniques including HPLC, GC, LC-MS/MS, GC-MS, ICP-MS, CE, SEC-MALS, CE-SDS, cIEF, NMR, KF, titrations, and instrumental and wet chemical techniques. Other duties may involve analytical method modification, development, and validation. The incumbent may function as the primary contact on one or more development projects. In- depth involvement with the project team concerning the chemistry of the project and analytical chemistry needs is expected
Core Responsibilities:
- Develop and validate new analytical procedures. Independently, detects and solves complex problems of high technical difficulty.
- Perform sample analysis using various analytical techniques (e.g., LC, GC, LC-MS, GC-MS, ICP-MS, ELISA, SEC-MALS, CE-SDS, cIEF, etc.), interpret results, and prepare high-quality documentation such as protocols, analytical reports, and summary reports.
- Document all analyses per SOPs.
- Prepare SOPs, test methods, and other GMP documentation.
- Independently, detect and solve complex problems of high technical difficulty.
- Apply knowledge and expertise from multiple disciplines (including QA, QC, Analytical and production) to achieve project goals.
- Conduct investigations independently.
- Troubleshoot analyses and instruments.
- Support qualification of reference materials.
- Develop new analytical procedures.
- Validate analytical methods.
- Prepare and review scientific reports.
- Interface with internal and external clients.
Qualifications:
- PhD in Analytical Chemistry or equivalent
- Minimum of 8 years’ experience in a GMP environment.
- Minimum of 5 years’ experience in method development and validation for small molecules Active Pharmaceutical Ingredients (APIs). Experience with Process Development of APIs.
- Experience with LC, GC, GC-MS, LC-MS, IC, spectroscopy, and wet chemistry.
- Experience mentoring staff members in an analytical department.
- Formal project management training.
- Experience with writing method validation protocols and reports desirable.
- Experience with Microsoft Office and other complex computer software (UPLC, Empower 3) desirable.
Our Commitment:
- Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
- Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.
- Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
- Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.
How to Apply:
At Veranova, we are on a misson to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise.
We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed.
If you are a veteran, first responder, or in the process of transitioning from service member to civilian life, we encourage you to apply. Your experience brings invaluable skills and insights that can contribute to our team.
For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Additional Information:
Applicants for this role must be authorized to work in the United States without further employer sponsorship.
Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.
Important Notice Regarding Recruitment Scams: Veranova is committed to providing a professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.
- Legitimate communications from Veranova will only come from official email addresses using our domain: @veranova.com.
- Legitimate LinkedIn communications will only come from active Veranova employees.
- Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).
- Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).
If you have any doubts or concerns about the authenticity of a job posting, please reach out to our HR department: (US) or (UK).
All your information will be kept confidential according to EEO guidelines.
Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.
All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.
Senior Research & Development Chemist
Posted today
Job Viewed
Job Descriptions
Job Description
Join Our Team as a Senior R&D Chemist!
CHT USA is a global leader in high-performance materials, and we’re looking for a skilled Senior Research and Development Chemist to join our team at the Cassopolis facility. If you're an initiative-taking leader with a focus on safety, efficiency, and continuous improvement, we'd love to hear from you!
At CHT USA, we foster a supportive workplace with competitive benefits, including medical, vision, dental, and life insurance starting on day 31. Our 401(k) plan allows participation in the first of the month after three months of employment, with a 3% company-paid contribution and full vesting from eligibility. We offer opportunities for growth, and we’d love to hear from you!
Apply Today!
As a Senior R&D Chemist, you will play a pivotal role in the development of cutting-edge silicone materials and processes. Your expertise will drive innovation through research, analysis, synthesis, and experimentation. With occasional travel, you’ll also represent our company at conferences, trade shows, and customer engagements.
What You’ll Do:
- Design and implement product and process improvements.
- Maintain detailed laboratory notebooks to document experiments and results.
- Develop and execute experiments, analyze data, and prepare technical reports.
- Troubleshoot and maintain laboratory instruments for optimal performance.
- Write technical papers, standards, and specifications.
- Collaborate with internal teams to create technical sales literature and support quality assurance efforts.
- Investigate and resolve customer complaints or product issues.
- Promote laboratory safety and compliance while suggesting improvements.
- Present research findings at conferences and trade shows.
- Engage in trade organizations, steering committees, and regulatory initiatives.
What You Bring:
- Education & Experience:
- Ph.D. in Chemistry (or related field) with a focus on silicones preferred, or
- M.S./B.S. in Chemistry with 7+ years of relevant industrial experience.
- ERP system experience is a plus.
- Knowledge & Skills:
- Advanced proficiency with Microsoft Office 365 Suite (Excel, Word, PowerPoint, Outlook).
- Familiarity with ERP systems like SAP, Sage, or Microsoft Dynamics.
- A creative approach to solving complex challenges.
- Personal Attributes:
- Strong interpersonal and leadership abilities.
- Effective organizational and time-management skills.
- A team player with a proactive and humble attitude.
Why Join Us?
- Be part of a dynamic team at the forefront of materials innovation.
- Work on challenging projects with opportunities to grow professionally.
- Represent our company at technical conferences and trade shows.
- Contribute to a collaborative culture that values curiosity, creativity, and continuous learning.
Take the next step in your career and make an impact in the field of silicone materials development. Apply today and let’s innovate together!
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About The Latest Drug development Jobs in United States!
Research & Development Lab Assistant
Posted today
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Job Description
Job Summary:
Assist and support the R&D Manager and the department in the development of new products and improvement of existing products. Under the direction of the R&D Manager fulfillment of sample requests from customers.
Essential Duties and Responsibilities:
Making experimental samples and performing various tests including sensory evaluation, moisture, pH and specific gravity measuring.
Alongside management, conduct shelf-life studies and perform various tests including sensory evaluation, moisture, pH and color measuring.
Preparing samples for customer requests including printing out recipes from the database, locating and weighing-out ingredients, making samples, packing, labeling, and shipping.
Contacting ingredient supplies in order to request samples.
Updating the E21 system with inventory changes.
Preparing consumer product evaluations for the R&D personnel and the Sales team.
Lab supply inventory management.
Organizing samples and ingredients storage.
Keeping lab room and lab equipment clean.
Job Requirements:
Being willing to taste, touch, and smell food samples and food ingredients.
Physical ability to perform tasks that may require prolonged standing and other activities necessary to perform job duties.
The ability to maintain a clean and organized work environment.
The ability to plan, prioritize, and organize work for project completion on a timely basis.
Food industry experience preferred.
Experience working with lab equipment preferred.
Culinary experience a plus.
Computer proficiency to include basic Microsoft Excel, Word, as well as Internet research skills.
Experience using database system preferred.
Follow safety standards in working with multiple services, tools, and equipment.
Perform any and all other duties as instructed by leadership and management.
Job Qualifications:
Good verbal and written communication skills.
Job Title: Engineer, Upstream Drug Development Facilities & Engineering (JP13636)
Posted 3 days ago
Job Viewed
Job Descriptions
Job Title: Engineer, Upstream Drug Development Facilities & Engineering (JP13636)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities & Engineering Substance Supply
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 1/23/2025.
Notes: Only qualified candidates need apply. Initial schedule M-F for the first month of training. Flexibility in schedule, role has potential to move to a Sun-Wed 4 day x 10 hour shift (estimate start time 8 am)
3 Key Consulting is hiring! We are recruiting an Engineer, Upstream Drug Development Facilities & Engineering for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Our Ideal Candidate: Works Onsite, is an expert in upstream drug substance, equipment ownership, specializing in cleaning systems like CIP, COP, Autoclaves, and Glass Washers. Has a strong foundation in engineering principles, excellent communicator.
Seeking an Engineer at our client’s main headquarters in Thousand Oaks, CA to join the GMP Facilities and Engineering (F&E) organization. This position will provide on-site engineering support for the B23 Drug Substance Plant.
Under general supervision, provides equipment ownership by being SME of equipment. This position is to be the engineer for cleaning systems, which includes CIP (Clean In Place), COP (Clean Out of Place), Autoclaves and Glass Washers. Main function is to ensure equipment is running safely and reliably for production. Applies basic engineering principles to troubleshoot, design and implement system modifications, perform function tests for small projects. Organizes, analyzes and presents interpretation of results for engineering projects and/or issues of minor to medium scope and complexity. Support senior engineers for the implementation of complex projects.
Top Must Have Skill Sets:
• Experience with regulated environments with working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech equipment.
• Direct experience with manufacturing process equipment including troubleshooting, reliability and performance improvements, and design optimization.
• Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
• Must be able to communicate clearly. Required to communicate out issues and updates to broader audience.
Day to Day Responsibilities:
Equipment troubleshooting, improvement and reliability projects, ensuring that equipment WOs are completed on time
• Function as a technical expert to equipment or systems.
• Perform the system owner role for assigned systems to ensure equipment safety, reliability and compliance.
• Work with manufacturing, maintenance, instrumentation, quality in order to resolve issues.
• Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.
• Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses.
• Specifying and overseeing a properly executed preventive maintenance program.
• Specifying proper spare parts for system.
Basic Qualifications:
M.S. 1+ years of experience B.S. and 2+ years in a GMP regulated environment. Troubleshooting or equipment ownership experience required.
Red Flags:
No troubleshooting or equipment ownership experience.
Why is the Position Open?
Supplement to the team’s workload.
Interview Process:
Interview with 3 engineers possibly in 1 to 2 interviews.
Can start interviewing ASAP.
We invite qualified candidates to send your resume to If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Job Title: Engineer, Upstream Drug Development Facilities & Engineering (JP13348)
Posted 3 days ago
Job Viewed
Job Descriptions
Job Title: Engineer, Upstream Drug Development Facilities & Engineering (JP13348)
Location: Thousand Oaks, CA. 91320
Business Unit: Facilities & Engineering Substance Supply
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $38 - $42/hour W2
Posting Date: 11/5/2024.
Notes: Only qualified candidates need apply. Initial schedule M-F for the first month of training. Flexibility in schedule, role has potential to move to a Sun-Wed 4 day x 10 hour shift (estimate start time 8 am)
3 Key Consulting is hiring! We are recruiting an Engineer, Upstream Drug Development Facilities & Engineering for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Our Ideal Candidate: Works Onsite, is an expert in upstream drug substance, equipment ownership, specializing in cleaning systems like CIP, COP, Autoclaves, and Glass Washers. Has a strong foundation in engineering principles, excellent communicator.
Seeking an Engineer at our client’s main headquarters in Thousand Oaks, CA to join the GMP Facilities and Engineering (F&E) organization. This position will provide on-site engineering support for the B23 Drug Substance Plant.
Under general supervision, provides equipment ownership by being SME of equipment. This position is to be the engineer for cleaning systems, which includes CIP (Clean In Place), COP (Clean Out of Place), Autoclaves and Glass Washers. Main function is to ensure equipment is running safely and reliably for production. Applies basic engineering principles to troubleshoot, design and implement system modifications, perform function tests for small projects. Organizes, analyzes and presents interpretation of results for engineering projects and/or issues of minor to medium scope and complexity. Support senior engineers for the implementation of complex projects.
Top Must Have Skill Sets:
• Experience with regulated environments with working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech equipment.
• Direct experience with manufacturing process equipment including troubleshooting, reliability and performance improvements, and design optimization.
• Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
• Must be able to communicate clearly. Required to communicate out issues and updates to broader audience.
Day to Day Responsibilities:
Equipment troubleshooting, improvement and reliability projects, ensuring that equipment WOs are completed on time
• Function as a technical expert to equipment or systems.
• Perform the system owner role for assigned systems to ensure equipment safety, reliability and compliance.
• Work with manufacturing, maintenance, instrumentation, quality in order to resolve issues.
• Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.
• Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses.
• Specifying and overseeing a properly executed preventive maintenance program.
• Specifying proper spare parts for system.
Basic Qualifications:
M.S. 1+ years of experience B.S. and 2+ years in a GMP regulated environment. Troubleshooting or equipment ownership experience required.
Red Flags:
No troubleshooting or equipment ownership experience.
Why is the Position Open?
Supplement to the team’s workload.
Interview Process:
Interview with 3 engineers possibly in 1 to 2 interviews.
Can start interviewing ASAP.
We invite qualified candidates to send your resume to If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.