We are seeking Senior Scientist candidates with extensive biotech industry experience in developing, optimizing, and scaling up downstream manufacturing processes from bench to pilot-scale production (preferably cGMP manufacturing).
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 (detergent, low pH). Candidates with Bio-Rad NGC and/or GE AKTA experience and with basic protein analytical skills (HPLC and capillary electrophoresis or SDS-PAGE) are preferred.
In addition to the above, candidates for the Senior Scientist position will demonstrate additional working knowledge in one or more of the following: DOE and statistical tools for design and analysis of experiments, QbD principles, scale-down model development and qualification, as well as process linkage and characterization studies. Senior scientist candidates should also have a good working understanding of current FDA and ICH guidelines and preferably have some IND CMC and regulatory filing experience.
Candidates must have excellent communication and writing skills, with extensive experience preparing technical documents (e.g. SOPs, protocols, technical reports, and/or batch records). Candidates must have a demonstrated ability to work independently, design and execute appropriately controlled experiments, analyze and interpret data critically, and maintain up-to-date laboratory notebooks.
- B.A/B.S., M.S. or PhD. in life sciences or biochemical engineering with a minimum of 10 years of biotech industry experience in downstream process development, optimization, and scale-up.
- Basic knowledge of GxP guidelines for the biotech industry
- Experience with BioRad NGC and/or GE AKTA systems and protein analytical methods preferred.
- Extensive working knowledge of all common chromatography and filtration methodologies.
- Tech transfer and/or pilot- or large-scale cGMP manufacturing experience a plus.
- 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
- 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.
- Senior Scientist position will demonstrate working knowledge in or more of the following: statistical tools and DOE, QbD principles, process characterization studies, FDA and ICH guidelines, IND and/or regulatory (CMC) filing experience.
- Plan, design, execute, and record experiments, and independently analyze results using good scientific principles and with keen attention to detail and quality. Maintain up-to-date GLP compliant lab notebook.
- 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 CMO if required) and conduct engineering and cGMP pilot manufacturing runs.
- Perform standard in-process analytical techniques including HPLC, SDS-PAGE/CE, and protein assays.
- Write development reports (progress, summary, tech transfer), protocols, and SOPs.
- Support drafting and/or revisions of production batch records for cGMP manufacturing as well as close-out of executed batch records with QA.