Merck Associate Principal Scientist 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:

Leading process development activities to execute large molecule upstream 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.

Direct management of 1-4 scientists.

Required:

B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 10 years of relevant experience; or Master's degree with 8 years of relevant experience; or Ph.D. with 4 years of relevant experience.

Large molecule process development, or relevant, experience including scaling (up and down) and tech transfer of large molecule drug substance processes.

Hands-on expertise in execution of process development with multiple programs and upstream and/or downstream 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.

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.

Preferred:

Knowledgeable in Drug Substance, end-to-end process development.

Subject Matter Expertise with upstream operations (aseptic operations, shake flasks, lab or pilot scale bioreactors running microbial or cell culture processes, single use systems) and/or downstream operations (lab or pilot-scale chromatography, filtration, centrifugation, or conjugation chemistry).

Experience with upstream and/or 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 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

Minimum 2 years of direct people management experience.

EEOC Poster at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at http://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

LHH-Sanofi-062018

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: Associate Principal Scientist

Primary Location: NA-US-PA-West Point

Requisition ID: PRO017533