Associate Principal Scientist, Engineering (Microbial Fermentation)

Job Description

The Chemical Commercialization Technology (CCT) department, which is part of our company's Manufacturing Division, is seeking self-motivated individuals who are looking for an opportunity to work in a highly collaborative environment that provides substantial technical responsibility and leadership of internal and external work.

The Associate Principal Scientist, Engineering position leverages scientific/technical experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small molecule pipeline.  Given the significant role of biocatalysis and enzymes in the portfolio, the ideal candidate should have a specific expertise in microbial fermentation and downstream processing and is expected to draw on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.   The successful candidate will play a pivotal role in developing internal technical capabilities via mentoring junior staff and enhancing fermentation and downstream processing laboratory capabilities, in addition to supporting transfer of technologies to commercial manufacturing.  The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on experimentation at the laboratory bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities. The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs). 

Position Qualifications:

Education Minimum Requirement:

• The position requires a BS and/or MS in Chemical Engineering, Bioengineering, Biological Engineering, Synthetic Biology or a related field from an accredited college/university plus at least 8 years of relevant work experience in process development or PhD with at least 4 years of relevant work experience post PhD defense. 

Required Experience and Skills:

Relevant work experience in chemical, pharmaceutical, large molecule, or vaccine process development, including the following:

• Experience and knowledge in microbial fermentation and downstream process development and optimization, as well as process scale-up and scale-down

• Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity

• Experience with process scale-up and technology transfer, moving from laboratory to pilot plant or factory

• Ability to mentor technical staff in the laboratory and through data analysis

• Highly effective communication and collaboration skills

• Good organizational, interpersonal, writing, and time management skills

• Lead and operate within a cross-functional process development team

Preferred Experience and Skills:

• Experience performing lab-based research/process development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and crystallization

• Experience leading file authoring, validation planning and execution

• Experience guiding internal/external technical discussions

• Familiarity with statistical design and analysis tools

• Familiarity with concepts and application of current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, e.g. in a pilot and/or factory setting

• Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design (QbD) principles. 

• Experience supporting/writing regulatory filings.

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