Senior Scientist, Upstream Pilot-Scale Lab Lead

Job Description

As part of Our Company’s Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.  

Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and external partners, this person will support late stage and commercial large molecule program activities within CCFS. The person will be responsible to support development activities in the Pilot-scale lab, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing vaccines and biologics.

Technical scope:

• Lead the hands-on execution of upstream pilot-scale experiments. Typical unit operations include shake flasks, wave rockers, 50 – 500L bioreactors, alternating flow filtration (ATF), centrifugation, and depth filtration.
• Coordinate staffing, inventory, waste management, equipment upkeep, budget management, data analysis, and documentation. Mentor other scientists as a subject-matter expert in pilot-scale operation.
• Collaborate with stakeholders across multiple biologics programs. Perform facility fit analysis to assess processing requests. Support tech transfers, process investigations, study design, and on-the-floor manufacturing support.
• Drive organizational excellence practices such as technical standards, process platforms, operational procedures, data management and visualization, and laboratory safety.
• Effectively communicate study results to stakeholders via presentations and technical reports.
• Provides technical leadership in the interpretations of trends observed in Pilot-scale process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA). Lead technical investigations and process changes that drive improvements to robustness.
• Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.

Required Minimum Education and Experience: 

• Bachelors’ degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with five (5) years of industry experience; OR
• Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or related field with three (3) years of industry experience; OR
• Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or related field with no experience

Required Expertise and Skills: 

• Hands-on experience with one or more of the upstream unit operations mentioned above.
• Mechanistic understanding of upstream unit operations and scale-up principles.
• Ability to manage dynamic timelines and priorities.
• Ability to effectively scope, assign tasks, and allocate resources for meeting project goals.
• Ability to independently design and execute experiments in a manner that meets quality expectations.
• Ability to independently drive continuous improvement.
• Well-developed organizational, record-keeping, and problem-solving skills, with an attention to detail.
• Excellent oral and written communication skills, especially in training others.
• Ability to foster a collaborative work environment focused on mentorship, coaching, and learning.

Preferred Expertise and Skills:

• Hands-on expertise with mammalian cell culture pilot-scale and/or manufacturing environment.
• Experience with process investigations and root cause analysis.
• Laboratory management or team leadership experience.
• Equipment commissioning and user acceptance testing experience.
• Current Good Manufacturing Practice (cGMP) awareness or experience
• Authoring of technical documentation in support of the following: process performance qualification (PPQ), risk assessment, cont