Merck KGaA Darmstadt Germany-posted 4 months ago
$169,700 - $267,200/Yr
Full-time • Senior
Onsite • West Point, PA
Chemical Manufacturing

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.

  • 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.
  • 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.
  • Developing, aligning, and ensuring project results meet requirements regarding technical quality, reliability, schedule, and cost.
  • Monitoring performance and recommending schedule changes, cost adjustments or resource additions.
  • Solving technical and non-technical problems throughout the life of the project.
  • Providing timely and accurate information and status updates to project sponsors and management.
  • Championing compliance and safety; promoting a culture of diversity, inclusion, and equity.
  • Ph.D. or Master's in Chemical Engineering, Bioengineering, Biological Engineering, or a related field.
  • Minimum 8 years of industry experience for Ph.D., 12 years for Masters, 16 years for Bachelors.
  • Strong fundamental knowledge and subject matter expertise with processing of biologics/vaccines.
  • 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 process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.
  • Adaptability and agility to prioritize and deliver complex objectives 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.
  • Experience with fermentation/cell culture process development for both biologics and vaccines.
  • Experience with stainless steel and high throughput microbioreactor systems.
  • Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.
  • Background in data science approaches related to cell culture and predictive modeling.
  • Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support.
  • Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles.
  • Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies.
  • Medical, dental, vision healthcare and other insurance benefits (for employee and family).
  • Retirement benefits, including 401(k).
  • Paid holidays, vacation, and compassionate and sick days.
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