Senior Scientist, Vaccine Process Development and Commercialization (Downstream)
- Spring House, PA
The Vaccine Process Development and Commercialization (VPDC) group within our Company's Manufacturing Division focuses on late stage process development, technology transfer, and in-line support of vaccine products (live-attenuated vaccines, inactivated vaccines, subunit, recombinant, polysaccharide, and conjugate vaccines).
We are committed to keeping pace with the ever-evolving infectious disease landscape by researching and developing vaccine candidates for important diseases. We are also developing promising new therapeutic approaches for cancer treatment, including gene and oncolytic virus therapies, which maybe the next breakthrough in cancer treatment. We seek an energetic, people-oriented leader with strong scientific and technical skills to lead the development and commercialization activities supporting multiple vaccine programs in late stage development.
In this role, you will be responsible for:
- Leading process development activities to execute large molecule downstream processing including lab-scale process development, in-process assay support, and process scale-up/scale-down.
- Execution of lab scale experiments and authoring associated technical reports and documents.
- Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within the Company network and at contract manufacturing organizations (CMOs).
- Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
- Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
- Provide mentor-ship and technical direction to other members of the team.
Education Minimum Requirement:
- B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 6+ years of relevant experience; or Master's degree with 4+ years of relevant experience; or Ph.D. with of relevant experience.
Required Experience and Skills:
- Large molecule process development, or relevant experience including scaling (up and down) and tech transfer of downstream large molecule drug substance processes (chromatography, filtration, analytics, single use systems).
- Experience with downstream lab or pilot-scale microbial and/or mammalian cell based large molecule processing.
- Expertise in lab scale experimental execution and experience with statistical data analysis and presentation of results/conclusions.
- Experience with authoring technical documentation.
- Outstanding communication and people skills.
- Ability to foster a collaborative work environment focused on mentor-ship, coaching, and learning.
- Experience with project strategic planning.
Preferred Experience and Skills:
- Knowledgeable in Drug Substance, end-to-end process development, including microbial, live virus vaccine, gene therapy, or oncolytic virus processes.
- Experience with downstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling.
- Experience with Quality by Design (QbD) and Lean Six Sigma principles
- Strong cross-functional background, enabling teams to reach peak performance.
- Ability to provide scientific mentor-ship and guidance to technical coworkers
- Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA)
- Experience with on-the-floor Good Manufacturing Practice ( GMP) manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations
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 ...
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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