Drug Substance Process Support Lab Specialist
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 DrugSubstance Process Support Lab’s Specialist will be a technicalcontributor with strong interpersonal, communication, and collaboration skillsresponsible for process development execution and post commercial processenhancements activities for multiple 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 and documents
- Provide technical/team support for late stage cell cultureprocess development, scale-down model development/execution/implementation,process characterization, commercial technology transfer, and qualificationstudies associated with the development and implementation of bulk processes,systems and facilities related to vaccine bulk 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 upstream process and raw materials
- Execute experimental studies as needed using the TechnicalOperations laboratory (investigational and/or developmental studies)
- Employ statistical tools for process analysis
- Actively participate on cross-functional manufacturing teamsto advance projects goals and deliverables related to process
- Author technical documents to support regulatory filingsincluding technical reports and risk assessments
Education Minimum Requirement:
- Bachelor of Science Degree in Chemical Engineering,Biochemical Engineering, Bioengineering, or related field with a minimum of two(2) years of relevant GMP experience.
Required Experience and Skills:
- Experience in vaccine or biologics drug substancemanufacturing within an aseptic, cGMP environment
- Experience authoring technical documentation within a cGMPcontext.
- Proven technical communication (written & presentation)skills
- Experience with project strategic plan development andmanagement
Preferred Experience and Skills:
- Hands-on expertise with lab or pilot-scale culture process(fermenters, bioreactors, static cell culture) and/or with large moleculepurification (chromatography, filtration, centrifugation)
- Technical knowledge and experience with cell culture, viruspropagation, and/or large molecule purification
- 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)
- Working 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 oftechnically complex subjects to regulatory inspectors
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.
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Job: Chemical Engineering
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck