Associate Director, Cell Culture and Fermentation Sciences
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 Director in the CCFS group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule program activities within CCFS. This person will be responsible for leading a team 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.
- Coordinate project planning, resourcing, staffing, supply and subcontract management, progress reporting, troubleshooting and people management.
- Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.
- Responsible for 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.
- Monitors performance and recommends schedule changes, cost adjustments or resource additions.
- Solves technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.
- Provides timely and accurate information and status updates to project sponsors and management.
- Participates in budget development and evaluating how project plan changes impact cost and schedule.
- Will oversee and coordinate work performed by outside contractors.
- May be responsible for managing large multifaceted projects as the leader of a cross-functional team.
- Ph.D. or Master’s in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum 4 year (Ph.D.), 6 years (Masters), 8 years (Bachelors) of industry experience.
Required Experience and Skills:
- Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins
- Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.)
- Comprehension of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors and bioreactor scale-up principles from laboratory to large scale
- Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.
- Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors
- Demonstrated ability for taking initiative, creativity, and innovation in problem-solving
- Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.
- Outstanding communication and people skills. Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
- Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions
Preferred Experience and Skills
- Experience with cell culture process development for both biologics and vaccines.
- Experience with 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.
- Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts)
- Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.
- 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 (FDA, EMA, JNDA, TGA).
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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