Responsibilities

1. Design, develop, optimize, characterize and execute microbial or mammalian upstream experiments independently or with minimal supervision

2. Scale-up and scale-down upstream processes

3. Transfer technology from client to Process Development (PD), and from PD to Manufacturing

4. Analyze upstream experimental data and develop technical solutions to the problems

5. Troubleshoot equipment and processes

6. Write, and review R&D protocols, batch records, SOPs, and reports

7. Maintain all notebooks and documentation according to department standards.

8. Able to work well in a team environment and independently.

9. Ensure and promote safe environmental and laboratory practices.

Qualifications

1. BS, MS, or PhD degree in Biochemical Engineering or related fields

2. BS with a minimum of 9+ years, MS with 7+ years, and PhD with 5+ years of upstream process development, tech transfer and/or manufacturing experience

3. Strong background in microbial fermentation (E. coli, Pichia pastoris), mammalian cell culture (CHO, HEK293) process development, and/or GMP manufacturing of therapeutic proteins or monoclonal antibodies

4. Extensive experience in fermentation/cell culture process development, primary recovery (centrifugation, depth filtration) optimization, process characterization, scale-up/down, and tech transfer

5. Solid GMP knowledge and CMC experience

6. Advanced written and presentation skills

7. Effective interpersonal and staff management skills

8. Attention to detail, strong organizational skills, and the ability to multitask

9. Proficient with the use of MS Office software (MS Excel, MS Word, MS PowerPoint) and statistical DOE software including JMP, Minitab, Design Expert).

10. Flexible and results-oriented