Merck Scientist, Biologics Process Development & Commercialization in West Point, Pennsylvania

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.

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines, biologics and consumer health products, as well as 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 people 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.

Biologics Process Development and Commercialization (BPDC), a manufacturing sciences organization within the Merck Manufacturing Division (MMD), is responsible for the commercialization of biological processes (novel therapeutic proteins) from Phase III through launch and transfer to the commercial supply network. Activities include process scale-up/scale-down, characterization and optimization, interfacing with a network of facilities for product manufacturing and subsequent validation and filing documentation, tech transfer to the supply network, and commercial product support, including investigations, post-launch process improvement, and development of second generation processes post-approval.

Under the general scientific and administrative direction of the Director of BPDC Upstream Process Development and Commercialization, and working in conjunction with internal and external partners, this individual will support late stage bulk process development, characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to therapeutic proteins. The individual will demonstrate scientific, experimental and tech transfer skills focused on cell culture processes.

Responsibilities:

  • Provide technical support in manufacturing sciences for drug substance development, characterization and commercialization teams, including the design, execution, and interpretation of lab-scale, pilot-scale and manufacturing-scale elements of a technical program to ensure processes are suitable for PPQ, licensure, and commercial manufacturing

  • Support definition and development of process control strategy

  • Support continuous improvement of post-launch manufacturing process

  • Identify and evaluate new/innovative technologies and work to implement new platforms with cross-functional early and late stage development teams

  • Partnering with commercial manufacturing teams to provide upstream technical support to ongoing manufacturing activities

  • Provide global support for commercial products (e.g. technical support, trouble shooting, deviation resolution, change control)

Education Minimum Requirement:

  • B.S.in Chemical Engineering or Biochemical Engineering or related fieldwith a minimum 2 years of relevant experience; or Master's degree with aminimum 1 year of relevant experience.

Required Experience and Skills ** :

  • Upstreamprocess development and manufacturing sciences experience.

  • Abilityto foster a collaborative work environment

  • Outstandingcommunication and people skills

  • Abilityto execute studies and experiments in the context of long-termcommercialization plans

  • Experiencewith Design of Experiments (DOE), and Lean Six Sigma principles

  • Experiencein using software and statistical tools (JMP, Spotfire, SIMCA) for datamining, data analysis, modeling and statistical process control (SPC)

Preferred Experience and Skills:

  • Upstreamprocess development, characterization and manufacturing sciencesexpertise across multiple programs and platforms

  • Knowledgeablein Drug Substance, end to end process development. Strong crossfunctional background.

  • Abilityto provide scientific support to technical coworkers and colleagueswithin and outside of Merck

  • Experiencesupporting/writing regulatory filings (IND, BLA)

  • cGMPexperience

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

For more information about personal rights under Equal Employment Opportunity, visit:

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

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

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: Scientist, Biologics Process Development & Commercialization

Primary Location: NA-US-PA-West Point

Requisition ID: PRO017314