The Upstream Cell Culture process development group is seeking a highly motivated and innovative Cell Culture and Media Lead. S/he will be responsible for leading a team of scientists and associate scientists to develop robust and scalable cell culture processes in support of Spark’s gene therapy clinical pipeline. The incumbent will supervise the planning and execution of development activities, as well as monitor and maintain the quality of the team's project outputs to meet organizational objectives. The incumbent will work with the downstream team and partner with the R&D organization to accelerate clinical candidates to the clinic, and partner with MS&T to support internal and external technical transfers of early-stage and late-stage clinical programs.
He/she will be responsible to:
- Lead the efforts of platform medium development to support growth and production of rAAV via triple transfection and/or use of a packaging and/or producer cell line.
- Provide technical leadership in upstream process design, optimization, characterization, and tech transfer, apply Quality by Design, risk assessment / prioritization to balance speed to clinic and product quality/yield/economic considerations to guide phase appropriate process development.
- Analyze and interpret process and analytical data and understand the process implications to make decisions on projects
- Oversee the preparation of technical reports, data summaries, tech transfer reports and technical presentations
- Author and review CMC sections to ensure high quality content for regulatory submissions. Serve as upstream technical SME for regulatory responses.
- Provide technical support for tech transfer, process validation and PAI.
- Represent Process Development group on cross-functional CMC teams, working proactively and collaboratively with other functional areas including R&D, Analytical Development, MS&T, Regulatory, Quality, internal manufacturing, external Manufacturing & CDMO group and Project Management.
- Drive new technology initiatives, establishing internal and external collaborations, and directing the necessary experiments for evaluation and implementation
- Manage an upstream team to achieve business goals and objectives.
- Hire & onboard new talent into the organization, manage performance and develop talent.
- Model the company’s values & culture in accordance with established policies
The PD Upstream Cell Culture and Media Lead position requires the following:
- The successful candidate will have in-depth familiarity and deep knowledge of cell culture development and use cutting edge techniques.
- He/she should have hands on working experience in media and feed development, suspension cell culture, and capability for troubleshooting process and/or equipment issues.
- He/she should have experience in mentoring and providing technical leadership to scientists and associates in cell culture and media development related activities.
% of Time
Job Function and Description
Responsible for leading the effort for a Cell Culture Team in alignment with Corporate Objectives and Process & Technology Development Department Goals. Fosters the Spark Culture: hires & integrates staff, manages performance and develops people. Actively participates as a member of the Upstream Process Development management team. Serves as an SME on upstream process and media development.
Responsible for leading the effort for Medium Development in alignment with Corporate Objectives and Process & Technology Development Department Goals. This effort will consist of parallel paths of in-house and outsourced efforts.
Responsible for Technology Transfer of upstream production processes to both internal and external stakeholders.
Draft protocols for studies and the subsequent technical reports as needed.
Attend meetings and perform administrative duties as needed.
Education and Experience Requirements
Key Skills, Abilities, and Competencies
- Ph.D. in Chemical/Biochemical engineering, Biochemistry, Virology, Cell Biology, Molecular Biology or a related scientific discipline with greater than >6 years of upstream process and media development experience in the biopharmaceutical industry.
- B.S./M.S. in Biology, Virology, Cell Biology, Molecular Biology, Biochemistry, Chemical Engineering or a related discipline with greater than >10 years of relevant experience
- In depth knowledge in upstream unit operations including harvest
- Versed in biologics CMC regulatory requirements and cGMPs
- Experience with process scale up, tech transfer, process characterization, PPQ and regulatory filing
- Effective project management and matrix leadership experience of technical teams/programs
- Experience with gene therapy product is a plus.
- Knowledge on microbial production processes is a plus.
- Applies QbD principles and scientific knowledge to the development of upstream manufacturing production processes that are robust, reproducible, and scalable.
Complexity and Problem Solving
- Expertise in developing media and feeds for mammalian cell culture processes
- Self-motivated, take initiatives and result oriented
- Expertise in Design of Experiments (DOE). Applying Quality by Design, risk assessment / prioritization to process development and characterization. Strong process data management and statistical analysis skills.
- Needs to be comfortable in a fast-paced environment and be able to collaborate with multi-disciplinary research teams at Spark.
- Ability to develop solutions to a variety of complex problems
- Excellent verbal and written communication skills
- Demonstrated ability to build and manage a high performing team
- Demonstrate expert problem-solving skills when faced with technical issues; capable of working on multiple tasks and developing solutions for a variety of highly complex problems.
- Ability to work collaboratively across a collaborative scientific and development environment.
- Must be comfortable in the fast-paced, biotech environment and interact with multi-
disciplinary Research and Development, Technical Development, Manufacturing, Quality
Assurance, Quality Control and Regulatory Affairs teams at Spark, as well as with Roche family
Internal and External Contacts
Other Job Requirements
- Fellow Upstream PD Team Members including Cell Line Development
- Fellow Technical Development Team Members such as: TD Downstream, TD Formulation, Pre-Clinical Operations (PCO), TD Lab Operations, and TD High-Throughput Automation.
- Cross-functional Team Members – Discovery Research, Quality Assurance, Analytical and Quality Control, Manufacturing Science & Technology, Manufacturing, Materials Management, Facilities, EHS, Regulatory Affairs and CMC Program Management.
- External Vendors that offer equipment and/or services for various aspects of Cell Culture process & technology development.
- Must be able to lift 25 pounds.
- Due to the inherent nature of cell culture, some weekend work and/or work on holidays may be needed. On occasion, long work hours may be required depending upon the experiment schedule.
- Handling large volumes of cell culture or related materials, such as tens of liters, may be required. Also, several viral materials, including AAV, adenovirus and lentivirus may be involved in the work.
- Ability to travel domestically and internationally as needed.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.