47 Chemical Engineering jobs in the United States

Director, Viral Vector Process Design United States - California - Santa Monica Process/Product Development & Operations Regular

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Kite is recruiting a highly experienced and strategic Director in our Viral Vector Process Design (PDe) organization based in Santa Monica, CA. This individual will be an integral leader of process development for the viral vector programs at Kite with a dedicated focus on upstream process development and scale-up of Lentiviral Manufacturing processes. The role also requires a strong emphasis on viral safety and regulatory compliance. The successful candidate will bring deep technical expertise and leadership in Lentiviral Vector (LVV) production for ex-vivo and in-vivo applications, with a proven track record of advancing candidates from research through IND-enabling studies as well as commercialization.

In addition, this individual will drive robustness, innovation and compliance across LVV process development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment, partnering closely with Research, Analytics, CMC, Regulatory, Commercial Manufacturing, Quality, and external partners.

In addition, this individual will drive robustness, innovation and compliance across LVV process development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment, partnering closely with Research, Analytics, CMC, Regulatory, Commercial Manufacturing, Quality, and external partners.

Responsibilities include, but are not limited to:

• Develop manufacturing processes for Viral Vector products and develop process improvements and efficiencies
• Lead and develop a high-performing Viral Vector Upstream process design team comprised of senior and junior level staff; collaborate cross-functionally within Viral Vector PDe organization as well as being a key player in interactions with stakeholders and partner organizations
• Lead and oversee design, planning and execution of laboratory studies to support cutting edge Viral Vector process and process platform design and development,
• Develop and execute Viral Vector process characterization studies to develop a thorough understanding of operating and performance parameters; Implement and maintain a state-of-the art knowledge management system
• Foster the growth and development of Viral Vector process design staff, including hands-on training if needed
• Guide the execution of Viral Vector process development, characterization, and phase-appropriate validation activities, as well as transfer of processes to manufacturing facilities
• Provide technical expertise and strategic leadership within project teams and in a matrix environment with a focus on upstream process development for LVV
• Provide Viral Safety subject matter expertise as needed to ensure robust viral safety testing strategies are implemented across all viral vector processes, including stringent adventitious virus testing plans that align with regulatory requirements and guidelines. Additionally, provide technical expertise to risk assessments and mitigation plans to address potential viral safety concerns throughout process development and manufacturing
• Leads a team that generates technical documentation, including but not limited to study protocols, process development and validation reports and process/manufacturing sections of regulatory documents
• Draft Viral Vector process development timeline scenarios and develop resource projections to enable pipeline project execution and inform portfolio decisions, including risk assessments, mitigation plans, lessons learned, standard methodologies
• Participate and influence a cross-functional development team to advance production activities
• Perform Viral Vector process analysis and trend process performance
• Build and maintain a collaborative culture with key partners (site and global) and customers including Research, Manufacturing and Quality
• In collaboration with other functions, implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines
• Oversee or serve on cross functional teams as needed.

Education and Experience:

• Advanced scientific degree (i.e. MD, PharmD, PhD) in in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering, Biotechnology and 8+ years of related experience OR
• Master’s Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 10+ years of related experience OR
• Bachelor’s Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 12+ years of related experience

Preferred Qualifications:

• Demonstrated previous experience and excellence in Lentiviral Vector process development with a focus on Upstream Process Development used for Cell/Gene Therapies, process technology transfer, scale translation and statistical DOE (design of experiments)
• Proven leadership in viral safety assessments
• Experience scaling Lentiviral Vector processes to clinical/commercial manufacturing scales
• Excellent communication and presentation skills and aptitude for problem solving
• Experience with the preparation of regulatory filings for US and external markets
• Understanding of GMP manufacturing
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, LVV processing technologies, cell therapy and gene therapy products, and process development execution
• Practical demonstration of hands-on process development including use of statistical design
• Comprehensive expertise in biosafety testing principles, viral clearance studies and virus risk mitigation strategies specific to viral vector manufacturing processes
• Deep understanding of regulatory guidelines and industry best practices related to adventitious virus testing and viral safety control
• Practical experience of cGMP manufacturing operations and fluency of regulatory regulations
• Experience with automation technologies
• Ability to think critically, and demonstrate troubleshooting and problem-solving skills
• Ability to lead and manage teams including track record of coaching and mentoring talent
• Excellent interpersonal, verbal, and written communication skills
• Ability to function efficiently and independently in a constantly evolving environment.
• Self-motivated with a strong sense of ownership and willingness to accept temporary responsibilities
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload
• Demonstrate ability to work and collaborate in cross functional and matrixed teams
• Experience driving and motivating teams to meet aggressive timelines and deliverables
• High energy level and a positive outlook with “can do” attitude to achieve goals and overcome obstacles
• Ability to travel based on business priorities

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Kite is recruiting a highly experienced and strategic Director in our Viral Vector Process Design (PDe) organization based in Santa Monica, CA. This individual will be an integral leader of process development for the viral vector programs at Kite with a dedicated focus on upstream process development and scale-up of Lentiviral Manufacturing processes. The role also requires a strong emphasis on viral safety and regulatory compliance. The successful candidate will bring deep technical expertise and leadership in Lentiviral Vector (LVV) production for ex-vivo and in-vivo applications, with a proven track record of advancing candidates from research through IND-enabling studies as well as commercialization.

In addition, this individual will drive robustness, innovation and compliance across LVV process development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment, partnering closely with Research, Analytics, CMC, Regulatory, Commercial Manufacturing, Quality, and external partners.

In addition, this individual will drive robustness, innovation and compliance across LVV process development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment, partnering closely with Research, Analytics, CMC, Regulatory, Commercial Manufacturing, Quality, and external partners.

Responsibilities include, but are not limited to:

• Develop manufacturing processes for Viral Vector products and develop process improvements and efficiencies
• Lead and develop a high-performing Viral Vector Upstream process design team comprised of senior and junior level staff; collaborate cross-functionally within Viral Vector PDe organization as well as being a key player in interactions with stakeholders and partner organizations
• Lead and oversee design, planning and execution of laboratory studies to support cutting edge Viral Vector process and process platform design and development,
• Develop and execute Viral Vector process characterization studies to develop a thorough understanding of operating and performance parameters; Implement and maintain a state-of-the art knowledge management system
• Foster the growth and development of Viral Vector process design staff, including hands-on training if needed
• Guide the execution of Viral Vector process development, characterization, and phase-appropriate validation activities, as well as transfer of processes to manufacturing facilities
• Provide technical expertise and strategic leadership within project teams and in a matrix environment with a focus on upstream process development for LVV
• Provide Viral Safety subject matter expertise as needed to ensure robust viral safety testing strategies are implemented across all viral vector processes, including stringent adventitious virus testing plans that align with regulatory requirements and guidelines. Additionally, provide technical expertise to risk assessments and mitigation plans to address potential viral safety concerns throughout process development and manufacturing
• Leads a team that generates technical documentation, including but not limited to study protocols, process development and validation reports and process/manufacturing sections of regulatory documents
• Draft Viral Vector process development timeline scenarios and develop resource projections to enable pipeline project execution and inform portfolio decisions, including risk assessments, mitigation plans, lessons learned, standard methodologies
• Participate and influence a cross-functional development team to advance production activities
• Perform Viral Vector process analysis and trend process performance
• Build and maintain a collaborative culture with key partners (site and global) and customers including Research, Manufacturing and Quality
• In collaboration with other functions, implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines
• Oversee or serve on cross functional teams as needed.

Education and Experience:

• Advanced scientific degree (i.e. MD, PharmD, PhD) in in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering, Biotechnology and 8+ years of related experience OR
• Master’s Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 10+ years of related experience OR
• Bachelor’s Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 12+ years of related experience

Preferred Qualifications:

• Demonstrated previous experience and excellence in Lentiviral Vector process development with a focus on Upstream Process Development used for Cell/Gene Therapies, process technology transfer, scale translation and statistical DOE (design of experiments)
• Proven leadership in viral safety assessments
• Experience scaling Lentiviral Vector processes to clinical/commercial manufacturing scales
• Excellent communication and presentation skills and aptitude for problem solving
• Experience with the preparation of regulatory filings for US and external markets
• Understanding of GMP manufacturing
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, LVV processing technologies, cell therapy and gene therapy products, and process development execution
• Practical demonstration of hands-on process development including use of statistical design
• Comprehensive expertise in biosafety testing principles, viral clearance studies and virus risk mitigation strategies specific to viral vector manufacturing processes
• Deep understanding of regulatory guidelines and industry best practices related to adventitious virus testing and viral safety control
• Practical experience of cGMP manufacturing operations and fluency of regulatory regulations
• Experience with automation technologies
• Ability to think critically, and demonstrate troubleshooting and problem-solving skills
• Ability to lead and manage teams including track record of coaching and mentoring talent
• Excellent interpersonal, verbal, and written communication skills
• Ability to function efficiently and independently in a constantly evolving environment.
• Self-motivated with a strong sense of ownership and willingness to accept temporary responsibilities
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload
• Demonstrate ability to work and collaborate in cross functional and matrixed teams
• Experience driving and motivating teams to meet aggressive timelines and deliverables
• High energy level and a positive outlook with “can do” attitude to achieve goals and overcome obstacles
• Ability to travel based on business priorities

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday.

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Job Requisition ID R0045650

Full Time/Part Time Full-Time

Job Level Director

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Join to apply for the Lead, Process Design Analyst role at Wellington Management

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About Us

About Us
Wellington Management offers comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique return and risk objectives of institutional clients in more than 60 countries, draw on a robust body of proprietary research and a collaborative culture that encourages independent thought and healthy debate. As a private partnership, we believe our ownership structure fosters a long-term view that aligns our perspectives with those of our clients.
About The Role
The Senior Process Design Analyst is a member of the Strategic Design & Delivery Team within the Infrastructure Platform. This role works globally across the Client, Investment and Infrastructure platforms to identify opportunities for process transformation and re-engineering in pursuit of strategic goals and objectives, increased efficiency and/or risk reduction. The Design Analyst prioritizes projects and drives the re/design process, including clear articulation of problem statement, desired business outcomes/return on value and implementation. Processes should be designed to scale and result in best client and investor experiences. The Design Analyst quickly develops deep expertise on the firm’s specific process capabilities and limitations.
Responsibilities
Perform various design and analytical roles that support overall development and delivery of Target Operating Model design at both a cross functional and business unit level – including:

• Identifying convergence and streamlining options between similar functions within a single or across multiple business units
• Advising business units in understanding their strategic drivers and converting these into strategic long-term objectives and business cases that provide the platform for detailed design work to start
• Experience in using Objectives & Key Results (OKRs) or similar frameworks to help leadership define and organize their business outcomes & track that into design & planning work
• Developing Business Process Management models to describe current state as well as target state design including Business Decision Modeling requirements
• Working with business units to develop optimal organizational models to meet their strategic objectives
• Working with our client excellence and regulatory teams to interpret new requirements and how they can be accommodated into their Target Operating Models
• Leveraging analytics tools & core methods to assist with root cause analysis and identify opportunities for improvement
• Partnering with our technology engineers & data strategists on defining architecture strategies and controls
• Collaborating across teams to take designs into reality through design advice and the project lifecycle
• Presenting and communicating ideas and designs
• Facilitating and driving communication to gain input and consensus from stakeholders in multiple teams and regions
• Staying connected to industry utilities and market vendors to help in the overall design of our strategy, processes and technology architecture and sharing this knowledge across Investment Operations
  
  

• Proven track record driving and successfully delivering complex, cross-function projects
• Strong root-cause analysis and creative problem-solving skills, coupled with the self-motivation and leadership to drive projects to completion
• Target Operating Model development
• Ability to consistently produce high quality project documentation, specifically project updates, requirements and test scripts
• Experience of working in an Agile environment, with knowledge of product management, agile prioritization and planning to enable early proof of outcomes, and how to translate long-term design ambitions into sprint-like modules using Epics, Stories or similar.
• Technical aptitude and ability to partner with and provide sounding board to technology engineers on technical solutions
• A disciplined organizational process, ability to work independently, and manage conflicting priorities
• Strong written and oral communication skills with confidence and ability to communicate with senior leaders
• Ability to deliver while working under pressure to tight deadlines; flexible and able to respond positively to changes / moving targets
• Demonstrated success collaborating, ability to influence without authority
• 7+ years experience
  
  

• Functional Architecture Design
• Business Process Re-Engineering
• Experience across a project lifecycle from scoping & analysis to delivery
• Degree in Operational Strategy
• Technical knowledge of financial service industry utilities
  
  

• Seniority level Not Applicable

• Employment type Full-time

• Job function Information Technology

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Reporting to the Health, Safety and Security (HS&S) Manager, you will be proving exemplary customer service to our clients.

Responsibilities:

• Drive the process safety culture at U.S. Oil & Refining Co. toward the goal of zero incidents.
• Manage and maintain renery process safety management programs including Management of Change (MOC), incident investigation, facility siting, coordinating and leading PHAs, HAZOPs, and Compliance Audits.
• Exemplify process safety leadership to all levels of the organization.
• Maintain safety programs and procedures to meet compliance requirements and local site and corporate objectives.
• Coordinate H&S audit and compliance programs to drive continuous improvement.
• Develop and deliver process safety management training in coordination with the Health and Safety Lead.
• Utilize compliance management software (KMS, Access, Meridian, etc.) to track actions to completion, report out KPIs, and assist in accountability.
• Monitor compliance with all federal, state and company process safety and records management standards.
• Coordinate and ensure delivery of all regulatory and internal process safety reporting requirements.
• Conduct required training for the site personnel to enhance process safety competency.
• Cross train and provide backup support for team members in the HS&S Department.
• Note: This description is intended to give you a general overview of the position. Additional responsibilities and opportunities may be identified based on current business needs.

Qualifications

• Applicants must be eligible to obtain a TWIC card (Transportation Worker Identification Credential).
• BS in Engineering or related experience is desired.
• Minimum of 5 years of experience in engineering or process safety preferred.
• Experience in rening, chemical processing, or heavy manufacturing industry and/or audits and assurance is desired.
• Demonstrated ability to work eectively and build credibility with all levels within the organization.
• Working knowledge of process safety regulations.
• Experience complying with Washington DOSH or CAL OSHA regulations is desired.
• Effective communication and interpersonal skills, with the ability to influence at all levels of the organization.
• Strong work ethic, adaptability, accountability and resilience.
• We are looking for a highly motivated, self-starter with a positive attitude, strong work ethic and accountability.
• Candidates should have a natural thirst for knowledge and curiosity to drive personal and professional development.
• Be proactive and willing to roll up their sleeves and work “hands on” with the local teams to execute their mission.
• Be able to achieve goals independently and contribute as a team player.
• Identify ways to improve processes and controls.
• Combine analytical skills and creativity in solving problems.
• Eectively communicate with the team and ask questions.

Director, Viral Vector Process Design United States - California - Santa Monica Process/Product Development & Operations Regular

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Kite is recruiting a highly experienced and strategic Director in our Viral Vector Process Design (PDe) organization based in Santa Monica, CA. This individual will be an integral leader of process development for the viral vector programs at Kite with a dedicated focus on upstream process development and scale-up of Lentiviral Manufacturing processes. The role also requires a strong emphasis on viral safety and regulatory compliance. The successful candidate will bring deep technical expertise and leadership in Lentiviral Vector (LVV) production for ex-vivo and in-vivo applications, with a proven track record of advancing candidates from research through IND-enabling studies as well as commercialization.

In addition, this individual will drive robustness, innovation and compliance across LVV process development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment, partnering closely with Research, Analytics, CMC, Regulatory, Commercial Manufacturing, Quality, and external partners.

In addition, this individual will drive robustness, innovation and compliance across LVV process development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment, partnering closely with Research, Analytics, CMC, Regulatory, Commercial Manufacturing, Quality, and external partners.

Responsibilities include, but are not limited to:

• Develop manufacturing processes for Viral Vector products and develop process improvements and efficiencies
• Lead and develop a high-performing Viral Vector Upstream process design team comprised of senior and junior level staff; collaborate cross-functionally within Viral Vector PDe organization as well as being a key player in interactions with stakeholders and partner organizations
• Lead and oversee design, planning and execution of laboratory studies to support cutting edge Viral Vector process and process platform design and development,
• Develop and execute Viral Vector process characterization studies to develop a thorough understanding of operating and performance parameters; Implement and maintain a state-of-the art knowledge management system
• Foster the growth and development of Viral Vector process design staff, including hands-on training if needed
• Guide the execution of Viral Vector process development, characterization, and phase-appropriate validation activities, as well as transfer of processes to manufacturing facilities
• Provide technical expertise and strategic leadership within project teams and in a matrix environment with a focus on upstream process development for LVV
• Provide Viral Safety subject matter expertise as needed to ensure robust viral safety testing strategies are implemented across all viral vector processes, including stringent adventitious virus testing plans that align with regulatory requirements and guidelines. Additionally, provide technical expertise to risk assessments and mitigation plans to address potential viral safety concerns throughout process development and manufacturing
• Leads a team that generates technical documentation, including but not limited to study protocols, process development and validation reports and process/manufacturing sections of regulatory documents
• Draft Viral Vector process development timeline scenarios and develop resource projections to enable pipeline project execution and inform portfolio decisions, including risk assessments, mitigation plans, lessons learned, standard methodologies
• Participate and influence a cross-functional development team to advance production activities
• Perform Viral Vector process analysis and trend process performance
• Build and maintain a collaborative culture with key partners (site and global) and customers including Research, Manufacturing and Quality
• In collaboration with other functions, implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines
• Oversee or serve on cross functional teams as needed.

Education and Experience:

• Advanced scientific degree (i.e. MD, PharmD, PhD) in in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering, Biotechnology and 8+ years of related experience OR
• Master’s Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 10+ years of related experience OR
• Bachelor’s Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 12+ years of related experience

Preferred Qualifications:

• Demonstrated previous experience and excellence in Lentiviral Vector process development with a focus on Upstream Process Development used for Cell/Gene Therapies, process technology transfer, scale translation and statistical DOE (design of experiments)
• Proven leadership in viral safety assessments
• Experience scaling Lentiviral Vector processes to clinical/commercial manufacturing scales
• Excellent communication and presentation skills and aptitude for problem solving
• Experience with the preparation of regulatory filings for US and external markets
• Understanding of GMP manufacturing
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, LVV processing technologies, cell therapy and gene therapy products, and process development execution
• Practical demonstration of hands-on process development including use of statistical design
• Comprehensive expertise in biosafety testing principles, viral clearance studies and virus risk mitigation strategies specific to viral vector manufacturing processes
• Deep understanding of regulatory guidelines and industry best practices related to adventitious virus testing and viral safety control
• Practical experience of cGMP manufacturing operations and fluency of regulatory regulations
• Experience with automation technologies
• Ability to think critically, and demonstrate troubleshooting and problem-solving skills
• Ability to lead and manage teams including track record of coaching and mentoring talent
• Excellent interpersonal, verbal, and written communication skills
• Ability to function efficiently and independently in a constantly evolving environment.
• Self-motivated with a strong sense of ownership and willingness to accept temporary responsibilities
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload
• Demonstrate ability to work and collaborate in cross functional and matrixed teams
• Experience driving and motivating teams to meet aggressive timelines and deliverables
• High energy level and a positive outlook with “can do” attitude to achieve goals and overcome obstacles
• Ability to travel based on business priorities

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Kite is recruiting a highly experienced and strategic Director in our Viral Vector Process Design (PDe) organization based in Santa Monica, CA. This individual will be an integral leader of process development for the viral vector programs at Kite with a dedicated focus on upstream process development and scale-up of Lentiviral Manufacturing processes. The role also requires a strong emphasis on viral safety and regulatory compliance. The successful candidate will bring deep technical expertise and leadership in Lentiviral Vector (LVV) production for ex-vivo and in-vivo applications, with a proven track record of advancing candidates from research through IND-enabling studies as well as commercialization.

In addition, this individual will drive robustness, innovation and compliance across LVV process development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment, partnering closely with Research, Analytics, CMC, Regulatory, Commercial Manufacturing, Quality, and external partners.

In addition, this individual will drive robustness, innovation and compliance across LVV process development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative environment, partnering closely with Research, Analytics, CMC, Regulatory, Commercial Manufacturing, Quality, and external partners.

Responsibilities include, but are not limited to:

• Develop manufacturing processes for Viral Vector products and develop process improvements and efficiencies
• Lead and develop a high-performing Viral Vector Upstream process design team comprised of senior and junior level staff; collaborate cross-functionally within Viral Vector PDe organization as well as being a key player in interactions with stakeholders and partner organizations
• Lead and oversee design, planning and execution of laboratory studies to support cutting edge Viral Vector process and process platform design and development,
• Develop and execute Viral Vector process characterization studies to develop a thorough understanding of operating and performance parameters; Implement and maintain a state-of-the art knowledge management system
• Foster the growth and development of Viral Vector process design staff, including hands-on training if needed
• Guide the execution of Viral Vector process development, characterization, and phase-appropriate validation activities, as well as transfer of processes to manufacturing facilities
• Provide technical expertise and strategic leadership within project teams and in a matrix environment with a focus on upstream process development for LVV
• Provide Viral Safety subject matter expertise as needed to ensure robust viral safety testing strategies are implemented across all viral vector processes, including stringent adventitious virus testing plans that align with regulatory requirements and guidelines. Additionally, provide technical expertise to risk assessments and mitigation plans to address potential viral safety concerns throughout process development and manufacturing
• Leads a team that generates technical documentation, including but not limited to study protocols, process development and validation reports and process/manufacturing sections of regulatory documents
• Draft Viral Vector process development timeline scenarios and develop resource projections to enable pipeline project execution and inform portfolio decisions, including risk assessments, mitigation plans, lessons learned, standard methodologies
• Participate and influence a cross-functional development team to advance production activities
• Perform Viral Vector process analysis and trend process performance
• Build and maintain a collaborative culture with key partners (site and global) and customers including Research, Manufacturing and Quality
• In collaboration with other functions, implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines
• Oversee or serve on cross functional teams as needed.

Education and Experience:

• Advanced scientific degree (i.e. MD, PharmD, PhD) in in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering, Biotechnology and 8+ years of related experience OR
• Master’s Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 10+ years of related experience OR
• Bachelor’s Degree in Biochemical Engineering, Virology, Chemical Engineering, Biomedical Engineering or Biotechnology and 12+ years of related experience

Preferred Qualifications:

• Demonstrated previous experience and excellence in Lentiviral Vector process development with a focus on Upstream Process Development used for Cell/Gene Therapies, process technology transfer, scale translation and statistical DOE (design of experiments)
• Proven leadership in viral safety assessments
• Experience scaling Lentiviral Vector processes to clinical/commercial manufacturing scales
• Excellent communication and presentation skills and aptitude for problem solving
• Experience with the preparation of regulatory filings for US and external markets
• Understanding of GMP manufacturing
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, LVV processing technologies, cell therapy and gene therapy products, and process development execution
• Practical demonstration of hands-on process development including use of statistical design
• Comprehensive expertise in biosafety testing principles, viral clearance studies and virus risk mitigation strategies specific to viral vector manufacturing processes
• Deep understanding of regulatory guidelines and industry best practices related to adventitious virus testing and viral safety control
• Practical experience of cGMP manufacturing operations and fluency of regulatory regulations
• Experience with automation technologies
• Ability to think critically, and demonstrate troubleshooting and problem-solving skills
• Ability to lead and manage teams including track record of coaching and mentoring talent
• Excellent interpersonal, verbal, and written communication skills
• Ability to function efficiently and independently in a constantly evolving environment.
• Self-motivated with a strong sense of ownership and willingness to accept temporary responsibilities
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload
• Demonstrate ability to work and collaborate in cross functional and matrixed teams
• Experience driving and motivating teams to meet aggressive timelines and deliverables
• High energy level and a positive outlook with “can do” attitude to achieve goals and overcome obstacles
• Ability to travel based on business priorities

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .

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Job Requisition ID R0045650

Full Time/Part Time Full-Time

Job Level Director

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We're the global leader in flexible workspace solutions, serving over 8 million people worldwide through our portfolio of premium brands. Our business model combines traditional office leasing with innovative service delivery, creating workspace solutions for everyone from solo entrepreneurs to Fortune 500 companies.

Join one of the world's largest and fastest-growing flexible workspace companies as we execute an aggressive expansion strategy across North America. We're seeking a dynamic Regional Vice President to lead sales performance and operational excellence across a multi-state region, managing approximately 400 locations with ambitious growth targets ahead.

This is a career-defining opportunity for a proven sales leader ready to step into a senior executive role with clear advancement potential in a high-growth environment.

As Regional Vice President, you'll be the driving force behind both sales performance and operational excellence across our Midwest region. This is fundamentally a sales leadership role - you'll spend 60% of your time driving two distinct sales channels while ensuring operational standards across hundreds of locations.

Key Responsibilities:

• Sales Leadership: Manage and optimize performance of two sales teams: Growth Directors (B2B new location acquisition/partnerships) and Area Sales Managers (B2C/B2B client acquisition)
• Regional Management: Lead regional strategy to meet or exceed revenue, occupancy, growth and profitability targets. Drive data-informed decision-making and continuous innovation in line with market trends
• Performance Management: Drive KPI performance across dispersed sales teams through data-driven leadership and hands-on coaching
• Business Development: Identify and capitalize on growth opportunities, including new market entry and expansion within existing markets. Partner with sales and marketing teams to drive regional conversion and customer acquisition. Monitor real estate market trends to identify emerging opportunities and assess project profitability
• Operational Oversight: Ensure consistent service delivery and operational standards across all locations. Monitor customer satisfaction metrics and implement action plans to improve experience and retention
• Strategic Execution: Lead regional growth initiatives as we scale

• MBA or equivalent advanced business degree
• 10+ years of progressive sales leadership experience at a multi-location company (retail, restaurants, services, commercial real estate- corporate side, telecommunications, financial services with branch networks, or similar dispersed business models)
• Multi-unit sales leadership across geographic regions (regional VP level experience strongly preferred)
• Hands-on sales background - you've had a progressive career in sales and personally closed deals earlier in your career
• B2B and B2C sales experience - comfortable with both corporate accounts and individual business clients
• Fast-paced, entrepreneurial environment experience with rapid growth/change
• Willing to travel regularly across the region

Location: Remote (But must be based in Chicago )

Competitive compensation package including:

• Base salary range: $300,000-$350,000
• Performance bonus
• Long-term incentive plan with equity component
• Comprehensive benefits package

Equal Employment Opportunity and Non-Discrimination Policy

Equal Employment Opportunity Statement: Both Keller Executive Search and our clients are Equal Opportunity Employers. For all positions, whether with Keller Executive Search or our clients, qualified applicants will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status.

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Compensation Information: For client positions, compensation information is available in the job post. If not provided, it will be shared during the interview process in accordance with applicable laws. When required by law, salary ranges will be included in job postings. Actual salary may depend on skills, experience, and comparison to current employees in similar roles. Salary ranges may vary based on role and location.

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• Rhode Island: We do not request or require salary history from applicants.
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Note: This job posting may be for a position with Keller Executive Search or one of our clients. The specific employer will be identified during the application and interview process. Employment laws and requirements may vary depending on the employer and location.