Title: Scientist/Senior Scientist, Upstream Process Development
Cellics Therapeutics is seeking a Scientist/Senior Scientist to support development activities including mammalian Cell Line and Cell Culture Development as well as technology transfer and oversight of Contract Development and Manufacturing Organizations (CDMOs) for clinical manufacturing. He/she will also be expected to contribute to cross-functional strategy and authoring of CMC reports and associated regulatory filings.
Essential Duties and Responsibilities:
- Directs mammalian cell line development and robust upstream process development
- Advances internal and external cell culture and general CMC development activities to improve cell density, viability and process robustness for production of lead candidates
- Provides guidance for clone selection and characterization, cell banking and cryopreservation
- Identifies, evaluates and implements new technologies/strategies to optimize CMC development
- Proposes strategies to address technical issues
- Generates protocols and methods; writes and reviews technical documents to support process development at CDMOs
- Efficiently supports and collaborates with downstream, analytical development, translational research, quality and regulatory teams on development programs
- Effectively analyzes, organizes and communicates results and program progress to colleagues and management
- Trains and mentors junior members of the team and collaborates across functional areas
- Ph.D. or M.S. in Cell and Molecular Biology, Biotechnology, Bioengineering or a related discipline.
- 2+ years of Industry or postdoctoral experience for Ph.D. or 5+ years of industry experience for M.S. in biologic cell line development and upstream process development.
- Extensive experience with mammalian cell culture or process development.
- Technical proficiency in screening and characterization of clonal cell lines for use in a cGMP manufacturing environment.
- Experience using design of experiments (DOE) software to guide process optimization.
- Experience working with CDMOs.
- Strong analytical skills and ability to work in a highly collaborative environment.
- Excellent written and oral communication skills.
If interested, please email a copy of your CV to firstname.lastname@example.org.