Merck Senior Scientist, Vaccines Process Development & Commercialization in West Point, Pennsylvania

**Please note: this posting is being used to pipeline candidates for future openings

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

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:

  • Leadingprocess development activities to execute large molecule upstream and/ordownstream processing including lab-scale process development, in-processassay support, and process scale-up/scale-down.

  • Executionof lab scale experiments and authoring associated technical reports anddocuments.

  • Collaboratingwith commercial manufacturing teams to support facility start-upactivities and provide on-the-floor support for drug substancemanufacturing, both within the Merck network and at contract manufacturingorganizations (CMOs).

  • Leadingassignment execution against accelerated, critical-path timelines in aright-first-time manner.

  • Authoringand/or reviewing technical documents to support Process PerformanceQualification (PPQ) and licensure.

  • Provide mentorship andtechnical direction to other members of the team which may includedotted-line reporting relationships.

Required:

  • B.S. in Chemical Engineering, Biochemical EngineeringBioengineering, Pharmaceuticals, Biochemistry, Microbiology plus 6 yearsof experience OR an MS plus 4 Years of experience

  • Large molecule process development, or relevant, experienceincluding scaling (up and down) and tech transfer of large molecule drugsubstance processes.

  • Hands-on expertisein execution of process development with multiple programs and unit operationsacross upstream and/or downstream unit operations.

  • Expertise in lab scale experimental execution and experience withDesign of Experiments (DOE), statistical data analysis and presentation ofresults/conclusions.

  • Experience authoring technical documentation to support regulatorysubmissions.

  • Outstanding communication and people skills.

  • Ability to foster a collaborative work environment focused onmentorship, coaching, and Subject Matter Expert development.

  • Experience with project strategic planning.

Preferred:

  • Knowledgeable in Drug Substance, end-to-end process developmentexperience.

  • Experience with upstream and/or downstream unit operationmathematical modeling, theoretical scaling calculations, computational fluiddynamics (CFD) modeling.

  • Experiencewith large molecule assay development and execution (HPLC, UPLC, MS).

  • Experience with Quality by Design (QbD) and Lean Six Sigmaprinciples.

  • Strong cross-functional background, enabling teams to reach peakperformance.

  • Ability to provide scientific mentorship and guidance to technicalcoworkers 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 includingproviding immediate responses on the shop floor to deviations and potentialdeviations.

  • cGMPexperience.

MMDHJ

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Process Engineering

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Senior Scientist, Vaccines Process Development & Commercialization

Primary Location: NA-US-PA-West Point

Requisition ID: PRO017532