Associate Principal Scientist, Downstream Vaccine Process Development and Commercialization:
Merck

PRO016709-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: PRO016709

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 latestage process development, technology transfer, and in-line support of vaccineproducts.  We seek an energetic,people-oriented leader with strong scientific and technical skills to lead thedevelopment and commercialization activities supporting multiple vaccineprograms.  


In this role, you will beresponsible for:

  • Leading process development activities to execute largemolecule downstream processing including lab-scale process development,in-process assay support, and process scale-up/scale-down.
  • Execution of lab scale experiments and authoringassociated technical reports and documents.
  • Collaborating with commercial manufacturing teams tosupport facility start-up activities and provide on-the-floor support for drugsubstance manufacturing, both within the Merck network and at contractmanufacturing organizations (CMOs).
  • Leading assignment execution against accelerated,critical-path timelines in a right-first-time manner.
  • Authoring and/or reviewing technical documents to supportProcess Performance Qualification (PPQ) and licensure.
  • Provide mentorship and technical direction toother members of the team which may include dotted-line reporting relationships.

Qualifications

Education: 

  • Bachelors Degree in Chemical Engineering, Biochemical Engineering  Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with a minimum of seven (7) years of relevant experience
  • Masters Degree with a minimum of five (5) years of relevant experience
  • Ph.D. with a minimum of three (3) years of relevant experience

Required:

  • Large molecule process development, or relevant, experience including scaling (up and down) and tech transfer of downstream large molecule drug substance processes (lysis, normal and tangential-flow filtration, chromatography, continuous centrifugation, precipitation, and conjugation chemistry).
  • Subject Matter Expertise with downstream lab or pilot-scale chromatography, filtration, centrifugation, or conjugation chemistry. 
Preferred:
  • Expertise in lab scale experimental execution and experience with Design of Experiments (DOE), statistical data analysis and presentation of results/conclusions.
  • 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.

Preferred: 

  • Knowledgeable in Drug Substance, end-to-end process development. 
  • Large molecule downstream process development expertise with multiple vaccine or biologics platforms including: recombinant protein, live viral, polysaccharide, and conjugate
  • 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

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.

 

Visa sponsorship is not available for this position.

 

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

 

            EEOC Poster

            EEOC GINA Supplement 



Job: Process Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications
Requirement