Senior Scientist, Downstream Vaccine Process Development and Commercialization Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Vaccine Process Development and Commercialization (V-PDC) group within the Merck Manufacturing Division (MMD) focuses on late stage process development, technology transfer, and in-line support of vaccine products. 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 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 Merck 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 mentorship and technical direction to other members of the team which may include dotted-line reporting relationships.
- Required: B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 5 years of relevant experience; or Master's degree with 4 years of relevant experience; or Ph.D. with relevant academic experience.
- Hands-on expertise in execution of downstream process development with multiple programs and unit operations
- Expertise in lab scale experimental execution and experience with Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions.
- Experience authoring technical documentation to support regulatory submissions.
- Experience with large molecule assay development and execution (HPLC, UPLC, MS).
- Outstanding communication and people skills.
- Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
- Experience with project strategic planning.
- cGMP experience.
- Knowledgeable in Drug Substance, end-to-end process development.
- 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 mentorship and guidance to technical coworkers and colleagues within and outside of Merck.
- Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA) .
- Experience with on-the-floor GMP manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Process Engineering
Job Title:Sr. Scientist, Engineering
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 3
Hazardous Materials: Potential to work with BSL2 compunds, live virus vaccines, general laboratory chemicals
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Scientific, Chemistry, Biomedical Engineering, Biochemistry, Microbiology, Engineering, Science