We are seeking candidates with extensive experience in developing, optimizing, and scaling up downstream processes from bench to pilot-scale; with preferably some experience working in cGMP manufacturing or regulated environment and/or a good understanding of regulatory/quality requirements.
Qualified candidates will demonstrate a broad and current technical/scientific knowledge of downstream process development, optimization, and scale-up methodologies to develop robust and scalable production processes. Suitable candidates will have hands-on experience in all common chromatography separation (affinity, ion exchange, mixed mode, hydrophobic interaction) and filtration methods (depth, traditional/single-pass TFF, virus, sterile) as well as virus inactivation. Candidates with Bio-Rad NGC and/or GE AKTA experience and having basic protein analytical skills (HPLC and capillary electrophoresis or SDS-PAGE) are preferred. Candidates for the Senior Scientist position will demonstrate additional knowledge of, and preferably have experience with, DOE and statistical programs for design and analysis of experiments, QbD, scale-down model development and qualification, as well as process range/linkage/characterization/robustness studies.
Candidates must have excellent technical writing skills and 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, independently determine next steps, analyze and interpret data independently, design and execute appropriately controlled experiments, and maintain up-to-date laboratory notebooks.
Qualifications:
- B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 5 years biotech industry experience in downstream process development, optimization, and scale-up.
- Experience with GE AKTA systems and protein analytical methods preferred.
- Basic knowledge of GxP policies and procedures and regulatory requirements in the biotech industry
- 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), QbD principles, and/or with scale-down model development/qualification, process range, linkage, and/or process characterization studies.
- Proficient with the use of MS Office software (Word, Excel, Power Point) and Unicorn software.
- 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.
Responsibilities:
- Develop, optimize, and scale up robust and efficient purification process for pilot production and subsequent cGMP manufacturing of Phase I candidates.
- Screen different resins and filters systemically and then conduct follow-on optimization, process range finding, and robustness studies to optimize protein yield and purity.
- Perform experiments using Bio-Rad NGC and GE AKTA chromatography systems, conventional and single-pass TFF systems, and industry standard filtration (harvest, sterile, viral) methods at bench and pilot-scale.
- Participate in transfer of downstream processes to in-house pilot GMP production suite or external CMOs.
- Perform standard in-process analytical techniques including HPLC, SDS-PAGE/CE, and protein assays.
- Organize, interpret, analyze, and present results in clear, concise fashion.
- 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.