Drug Substance Downstream Process Support Lab Senior Specialist:
Merck USA

Merck USA
Durham North Carolina
Requisition ID: CHE005814

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 Maurice R. Hilleman Center for Vaccine Manufacturing islocated in Durham, NC. This state of the art facility, established in 2004,manufactures Merck’s lifesaving vaccines in bulk and finished forms.  Due to the importance of this facility inMerck’s Vaccine Manufacturing network, the facility has seen rapid growth inproduction volumes and new employees over the last several years; currentlyDurham employs 1,000+ people.


Durham’s Drug Substance Process Support Lab’s DownstreamLead will be a technical leader with strong interpersonal,communication, and collaboration skills responsible for implementation oftechnology transfer process knowledge, post approval support, and postcommercial process enhancements activities for pipeline vaccine programs.


Key responsibilities may include but are not limited to:

  • Provide direct, hands-on execution of lab scale experimentsand author associated technical reports anddocuments
  • Provide technical/team support and leadership for late stagedownstream process development, scale-down modeldevelopment/execution/implementation, process characterization, commercialtechnology transfer, and qualification studies associated with the developmentand implementation of bulk processes, systems and facilities related to vaccinebulk products
  • Embed with  VaccinesProcess Development & Commercialization (V-PDC) to provide support forpipeline vaccines from phase II through launch, as required
  • Support definition and development of process controlstrategy including identification of critical process parameters and criticalmaterial attributes for downstream process and raw materials
  • Conduct experimental studies as needed using the TechnicalOperations laboratory (investigational and/or developmental studies)
  • Provide post approval support and downstream subject matterexpertise support to ongoing manufacturing activities.
  • Provide deep SME knowledge for  manufacturing investigations support (Productand process deviations and complex material-related)
  • Collaborate with internal/external partners, e.g.Procurement, Supplier Development & Performance Management
  • Develop effective data analytics methodologies for processand raw materials including statistical process control
  • Actively participate on cross-functional manufacturing teamsto advance projects goals and deliverables related to process and raw materials
  • Author, review, and/or edit technical documents to supportregulatory filings including technical reports, risk assessments, and CTDsections
  • Lead aspects of regulatory inspections by presenting anddefending technical documentation, investigations, and change controls
  • Evaluate and develop innovative process technologies,continuous process improvements and post launch process enhancements

This position begins 100% at the West Point PA site for anestimated duration of 1 year, then transition to the Durham NC site, which isthe position’s permanent location.  Thistransition will be managed under applicable Merck’s Global Mobilitypolicies.  After the West Pointassignment has concluded, the role will revert to Durham. 


Education Minimum Requirement:

Bachelor of Science Degree in Chemical Engineering,Biochemical Engineering, Bioengineering, or related field with five (5) yearsof relevant GMP experience - OR -  a Master of Science Degree with three (3) years ofrelevant GMP experience - OR -  a Ph.D. with relevant academic experience .

Required Experience and Skills:

  • Experience in vaccine or biologics manufacturing within anaseptic, cGMP environment
  • Experience authoring technical documentation within a cGMPcontext
  • Proven leader with influence and outstanding communication(written & presentation) skills
  • Experience with project strategic plan development andmanagement
  • Ability to foster a collaborative work environment focusedon mentorship, coaching, and Subject Matter Expert development.


Preferred Experience and Skills:

  • Hands-on expertise in execution of downstream large moleculeprocess development with multiple unit operations
  • Large molecule process development, or relevant, experienceincluding scaling (up and down) and tech transfer of downstream large moleculedrug substance processes (e.g chromatography, centrifugation, filtration)
  • Technical knowledge and experience with large moleculepurification
  • Experience with on-the-floor cGMP manufacturing supportincluding providing immediate responses on the shop floor to deviations andpotential deviations 
  • Experience in new product introduction and technologytransfer
  • Ability to drive studies and experiments in the context of along-term commercialization plan
  • Ability to provide scientific mentorship and guidance totechnical colleagues
  • Proficient using statistical tools (JMP or Minitab) forexperimental design, data analysis and modeling
  • Lean Six Sigma belt certification
  • Experience with Quality by Design (QbD)
  • Experience with Design of Experiments (DOE)
  • Strong understanding of process risk assessment tools
  • Experience authoring technical documents supportingregulatory filings (IND, BLA)
  • Experience with responding to regulatory questions withmultiple agencies (FDA, EMA, JNDA,).
  • Experience with face to face presentation of technicallycomplex subjects to regulatory inspectors 
  • Advanced degree (MS, PhD) in science or engineering

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 [email protected].


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.


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Job: Chemical Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications