Department: Protein Development and Manufacturing
Reports To: VP, PD/MFG
Status: Full Time/Exempt
We are seeking 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.
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 5 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.
- 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.
Qualified, interested candidates should send a resume to: firstname.lastname@example.org