Principal Scientist, Engineering

Job Description

As part of Our Company’s Manufacturing Division, within the Vaccines Drug Substance Commercialization (VDSC), the Upstream department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for the upstream portion of vaccines drug substance processes. VDSC 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 the Director in the VDSC-Upstream group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule program activities. The individual will be responsible for leading a team to support development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing commitments for vaccines. 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.

In this role, the successful candidate will be responsible for:

• Coordinating project planning, resourcing, progress reporting, troubleshooting and potentially people management.

• Serving as the scientific/technical mentor for junior staff.  Providing technical guidance in the various aspects of vaccine upstream process development/commercialization for large molecule products. This role may include management of direct reports.

• Guiding process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.

• Managing large multifaceted projects as the leader of a cross-functional team. 

• Develop, align, and ensuring project results meet requirements regarding technical quality, reliability, schedule, and cost.

• Monitoring performance and recommends schedule changes, cost adjustments or resource additions.

• Solving technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.

• Providing timely and accurate information and status updates to project sponsors and management, including escalation/de-escalation as required.

• Championing compliance and safety; promoting a culture of diversity, inclusion, and equity.

Education Requirements:  

• Ph.D. or Master’s in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum 8 year (for Ph.D.), 12 years (for Masters), 16 years (for Bachelors) of industry experience.

Required Experience, Skills and Competencies:

• Strong fundamental knowledge and subject matter expertise with processing of biologics/vaccines (large molecule products), recent advances, and challenges in the field

• Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.

• Experience in leadership of CMC development teams.

• Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.

• Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.

• Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.

• Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.

• Demonstrated commitment and experience to coach and mentor staff to maximize talent development and utilization.

• Excellent interpersonal and communication skills

Preferred Experience and Skills:

• Experience with fermentation/cell culture process development for both biologics and vaccines.

• Experience with stainless steel and high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.

• Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.