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Director Cell Line Development information

What are the key skills and qualifications needed to thrive as a Director Cell Line Development, and why are they important?

To excel as a Director Cell Line Development, you need advanced knowledge in cell biology, molecular biology, and bioprocessing, often backed by a Ph.D. and significant industry experience. Expertise with technologies such as CRISPR, high-throughput screening, cell culture automation systems, and regulatory standards like GMP is essential. Strong leadership, strategic planning, and effective communication are vital soft skills for guiding teams and collaborating across departments. These competencies ensure the efficient creation of robust cell lines critical for biologics development and organizational success.

What does a Director of Cell Line Development do?

A Director of Cell Line Development leads teams responsible for creating and optimizing cell lines used in the production of biopharmaceutical products, such as therapeutic proteins and antibodies. This role involves overseeing scientific strategy, ensuring regulatory compliance, and collaborating with cross-functional teams to meet project goals. Directors also provide technical guidance, manage budgets, and contribute to the development of new technologies and processes. Their work is critical in ensuring high-yield, stable, and safe cell lines for large-scale manufacturing.

What are the primary challenges a Director of Cell Line Development faces when overseeing multiple projects simultaneously?

A Director of Cell Line Development often manages several projects at different stages, which requires balancing timelines, resources, and technical challenges. Coordinating cross-functional teams—such as upstream process development, analytical, and quality assurance groups—can be complex, especially when each project has unique scientific hurdles and regulatory requirements. Effective communication, prioritization, and risk mitigation are key skills needed to ensure projects progress smoothly and meet critical milestones. Additionally, maintaining up-to-date knowledge of evolving technologies and regulatory guidelines is essential to lead teams successfully.
What are the most commonly searched types of Cell Line Development jobs in California? The most popular types of Cell Line Development jobs in California are:
What cities in California are hiring for Director Cell Line Development jobs? Cities in California with the most Director Cell Line Development job openings:
Director Cell Line Development jobs near you
Infographic showing various Director Cell Line Development job openings in California as of June 2026, with employment types broken down into 1% Internship, 80% Full Time, 13% Part Time, 5% Contract, and 1% Nights. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.
Sr. Scientist, Downstream and Biologics Formulation Development

Sr. Scientist, Downstream and Biologics Formulation Development

Avid Bioservices

Tustin, CA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 2 days ago

Job description

Description
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
Avid is seeking a highly motivated and technically strong Sr. Scientist, Downstream and Biologics Formulation Development to lead biologics formulation development while contributing to integrated downstream process development within a fast-paced, client-facing environment. This role is responsible for defining formulation strategies, executing technical studies, and supporting cross-functional integration as the capability expands. Additional responsibilities include designing downstream purification processes for protein-based biologics, viral clearance studies, scale-down and scale-up activities, and technology transfer to manufacturing. The individual will collaborate closely with Cell Line Development, Upstream Process Development, Analytical Sciences, MSAT, DS/DP Manufacturing, Program Management, and external partners to support client programs.
Key Responsibilities:
  • Lead formulation development for biologics, including pre-formulation assessments, excipient screening, and stability studies. Demonstrated experience in formulation development for complex biologic modalities-including antibody-drug conjugates (ADCs)-with understanding of modality-specific stability and developability challenges is highly advantageous.
  • Lead downstream process development for biologics, including capture chromatography, polishing chromatography, viral inactivation/filtration, and tangential flow filtration (TFF).
  • Extensive hands-on experience with analytical techniques for protein characterization, including DLS, DSF, SEC, CE, rheology, and spectroscopy. Design and interpret analytical testing strategies including HPLC (SEC & IEX), CE-SDS, SDS-PAGE, UV spectroscopy, and other biophysical assays to support process development and formulation studies.
  • Expertise in developing high concentration protein formulations and resolving issues such as aggregation, viscosity, and solubility. Able to identify and mitigate formulation risks including precipitation and chemical degradation.
  • Design experiments, analyze data, and prepare technical protocols, reports, and development summaries.
  • Establish and drive scientific strategy, workflows, and best practices for early- to late-stage biologics formulation development, with the ability to operate independently in a dynamic, fast-paced, client-facing environment with evolving priorities.
  • Serve as a technical subject matter expert (SME) in client engagements, including proposals, presentations, and project reviews; prior line management or informal leadership experience is advantageous.
  • Collaborate effectively with cross-functional teams to align project timelines, priorities, and resource planning.
  • Mentor and develop junior scientists and technical staff, and support onboarding of new team members.
  • Evaluate and implement new technologies and platform approaches to enhance internal capabilities and drive innovation.
  • Ensure compliance with applicable quality, regulatory, and safety standards.
  • Perform additional responsibilities as required to support evolving business and project needs.
  • Occasional travel may be required (by land or air) to attend conferences, seminars, off-site client meetings, and marketing events as needed.

Minimum Qualifications:
  • Master's degree/PhD degree in Biochemistry, Chemistry, or related field and minimum 4-6 years of relevant experience and demonstrated working knowledge of scientific principles.
  • Prior experience in formulation development, stability studies, and analytical characterization of biologics or strong background in biochemical and biophysical characterization of proteins with deep understanding of protein structure and function.
  • Experience in development of ultra-high concentration and pre-developability assessment
  • Proven record of strong technical writing and communication skills.
  • Ability to thrive in a dynamic, cross-functional environment.

Preferred Qualifications:
  • Ph.D. in Biochemistry, Chemistry, or related field with 4-6 years of industry experience, or M.S. with 6-10 years of experience.
  • Prior experience in formulations process development and/or downstream process development of biologics is a plus.
  • Experience mentoring or leading scientific staff preferred.
  • Candidates with strong expertise in either biologics formulation development or downstream process development will be considered, with opportunities to contribute across both areas.

Position Type/Expected Hours of Work:
This role is a full-time onsite position. Days and hours of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $147,200-$184,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
  • You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
  • Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
  • You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
  • You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.

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