About the roleSecretome is seeking a highly motivated Senior Scientist, Process Development, reporting directly to the Head of Process Sciences, to lead process development and optimization in support of our novel allogeneic cell therapies.
This role will be responsible for the design, optimization and scale -up of cell processing workflows, the execution of cell processing runs and ensuring high yield, quality and regulatory compliance of the drug product.
This role will work closely with Analytical Development, other cross-functional teams and external entities to establish fit-for-purpose processes, generate high-quality data and support process understanding, product characterization and technical transfer of processes into a GMP environment.
What you'll do- Support optimization of cell therapy workflows from cell expansion to harvest and formulation
- Execution of small to medium scale cell processing in 3D Bioreactor
- Resolve challenges and explore alternative equipment or production units
- Coordinate with the Analytics team the in-process sampling and characterization of cell products and other relevant product attributes
- Troubleshoot existing processes and experimental challenges, identify root causes, and implement scientifically sound solutions, propose improvements through clear communication to senior management
- Develop protocols, reports, technical summaries, and other scientific documentation in accordance with company procedures and applicable regulatory expectations
- Maintain accurate and complete laboratory records and ensure work is performed in accordance with safety and compliance requirements
- Present results, scientific conclusions and process improvements to cross-functional project teams
- Support laboratory operations, ensure material and equipment readiness
- Work strategically to accelerate the development and implementation of novel technologies for integration into new and existing drug products
- Develop platforms to support current and new product formats, increased product control, lower cost, and lower operational laboratory complexity
- Participate in project team meetings and decisions, working closely with other functions such as Research, Analytical, Manufacturing, Program Management, and others
- Prepare and present to collaborators and external entities (CDMO), on plans and roadmap to meet GMP manufacturing goals
- Support technology transfer of processes, and serve as SME with external organizations
- Support CMC (Chemistry, Manufacturing, and Controls) sections for regulatory filings (IND/BLA)
Qualifications- Ph. D/ Master degree in Biochemistry, Cell Biology, Bioengineering, Biological Sciences with min. 4/ 6 years of relevant industry experience in process development for cell therapies
- Strong hands-on experience with stirred tank bioreactors at various scales
- Innovative, problem-solving and organizational skills are required
- In-depth knowledge of biotherapeutics processes with preferred experience using small and medium scale stirred tank bioreactors for cell therapies
- Demonstrated ability to design and execute cell process development, assist in process gap analysis and provide scientific guidance and recommendations on process optimization
- Hands-on experience in upstream/downstream bioprocessing
- Familiar with the FDA regulatory requirements for drug products and IND filing
- Knowledgeable of cGMP requirements for processes and technology transfer
- Ability to technically troubleshoot and resolve challenges to successfully produce cell therapy products at a high-performance rate
- Must have strong interpersonal and communication skills, be a team player and be willing to work in a cross-functional environment
- Support generation of batch records and technical transfer packages
