We are seeking candidates with extensive experience in developing, optimizing, and scaling up cell culture processes from bench to pilot-scale; with preferably some experience with cGMP manufacturing and knowledge of regulations preferred.

Qualified candidates will demonstrate a broad and current technical/scientific knowledge of cell culture process development, optimization, and scale-up methodologies to develop robust, scalable, high-titer cell culture processes. Suitable candidates will have hands-on experience working with different mammalian expression systems, shaker and spinner flask cultures, conventional and single-use bioreactor systems, and have a thorough understanding of cell culture laboratory techniques and practices. Suitable candidates will have experience conducting media screening and feed strategy optimization studies as well as studies to identify and determine appropriate ranges of (critical) process parameters to optimize cell growth and productivity. Candidates should have a thorough understanding of current FDA and ICH guidelines regarding cell culture drug substance processes. Candidates for the Senior Scientist position will demonstrate additional knowledge of, and preferably have experience with, statistical tools, DOE (and software) and QbD principles as well as process range finding and characterization studies.

Candidates must have excellent technical writing skills with experience in preparing SOPs, protocols, technical reports, and/or batch records. Additional IND CMC and regulatory filing experience is a plus. Candidates must have good communication and interpersonal skills. Candidates must have a demonstrated ability to think critically, analyze and interpret data independently.

• B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 5 years biotech industry experience in cell culture process development, optimization, and scale-up.
• Hands-on experience in upstream laboratory activities including the operation of mini/bench to pilot scale bioreactor systems.
• Knowledge of bioreactor characterization and engineering principles as well as robust understanding of biochemistry and cell metabolic pathways.
• Knowledge of CMC regulatory requirements for biological pharmaceutical products, tech transfer and/or pilot- or large-scale cGMP manufacturing a plus.
• Senior level candidates should have knowledge of statistical tools and DoE (incl software) principles as well as basic process range finding and characterization studies.
• Proficient with the use of MS Office software (Word, Excel, Power Point).
• Excellent problem solving, organizational, and time management skills
• Must demonstrate initiative and be self-motivated
• Must have excellent communication and writing skills
• Positive attitude and interpersonal skills and the ability to work in team-oriented environment are essential
• Plan, design, execute, and record experiments using good scientific principles and with keen attention to detail.
• Candidates must have a demonstrated ability to think critically and analyze and interpret data independently.
• Can coordinate and prioritize parallel tasks.
• Must be flexible and able to adapt to changing demands.

• Develop, optimize, and scale up robust and high-yield cell culture fed-batch processes for pilot production and subsequent cGMP manufacturing of Phase I candidates.
• Characterize cell lines and evaluate cell line stability and suitability for pilot/GMP manufacture.
• Use DOE and other scientific methods to determine optimal growth parameters, media formulations, and feed strategies in small-scale shakers and bioreactors.
• Participate in transfer of cell culture processes to in-house pilot GMP production suite or external CMOs.
• Organize, interpret, analyze, and present results in clear, concise fashion.
• Participate in transfer of downstream processes to in-house pilot GMP production suite or external CMOs.
• Write development reports (progress, summary, tech transfer), protocols, and SOPs.
• Draft production batch records for GMP manufacturing, support and troubleshooting GMP production activities
• Maintain up-to-date GLP compliant lab notebook.