Sr. Scientist, Engineering

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

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 Principal Scientist 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, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing vaccines and biologics. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring.

Technical scope:

• Directs project team focusing on process characterization, technology transfer and validation of biopharmaceutical molecules with line-of-sight for licensure and commercialization. 

• Responsible for planning or executing scale studies to support commercial process validation, process characterization, and investigation evaluations, including studies performed either in-house or externally. 

• Design, plan, and execute laboratory experiments to generate high quality data.  Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports. 

• Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within our Company network and at contract manufacturing organizations (CMOs). 

• Provides technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA). Lead technical investigations and process changes that drive improvements to yield and/or robustness.

• Authors required regulatory and technical documentation associated with process Tech Transfer and validation.  Ensures that process/product are developed and documented according to standard company practices.  Supports regulatory queries and inspections as required.

• Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.

Minimum Required Education and Experience: 

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

Required Expertise and Skills: 

• Large molecule process development, including scaling (up and down) and tech transfer of drug substance processes.  

• Expertise in upstream lab scale experimental execution, Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions. 

• Expertise authoring technical documentation to support regulatory submissions leading to product licensure. 

• Outstanding communication and people skills. Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development