Cell and Gene Therapies Drug Product Development (CGDPD) is a department within a Process Development Division in Center of Breakthrough Medicines. CGDPD is responsible for drug product process development and tech transfer for manufacturing of various modalities of allogeneic and autologous cell and gene therapies. CGDPD represents a unique diverse team of scientists and engineers driving end-to-end Drug Product development efforts in advanced therapies. The Scientist in Process Development department, Drug Product group will be a laboratory-based role, operating independently and within a cross-functional team to progress clients’ cell and gene therapy programs and projects. The candidate will be a self-starter responsible leading, designing and performing experiments in support of in support of formulation, tech transfer and fill-finish activities for various modalities of advanced therapies.
- Design and execute phase-appropriate studies in support of formulation selection and drug product manufacturing unit operations including stability and excipient selection, freeze/thaw, mixing, sterile filtration, and filling.
- Monitor and drive the tech transfer and execution of drug product development and cGMP manufacturing plans for gene and cell therapy customers.
- Design and execute in-use stability and compatibility studies to support clinical administration of novel advanced therapies
- Set-up and lead stability studies and data interpretation.
- Organize and participate in technical discussions aimed at resolution of issues with suppliers, processes, and deviations.
- Interface with clients to establish/maintain a positive relationship, ensure expectations are clear, plan for right-first-time execution, and complete studies to successfully deliver against the program.
- Prepare technical reports and present the finding to colleagues and management
- Supervise, guide, and mentor junior scientists within the drug product process development team.
- Follow general laboratory safety and training requirements
- BS in Biological, Pharmaceutical sciences, Engineering or Chemistry with 5 years experience, or MS with 3 years of work experience, or PHD with at least 1 year of experience.
- Biologics or gene therapy development experience.
- Experience in development, scale-up, technology transfer, and optimization of aseptic drug product manufacturing processes.
- Demonstrated hands on experience with parenteral DP manufacturing including technical transfers and process validation deliverables.
- Ability to interpret and analyze data from analytical assays and design appropriate experiments.
- Excellent written and verbal communication skills
- Ability to use scientific literature to support novel projects and/or experimental data
- Proven publication and presentation history.