Associate Principal Scientist, Biologics Pilot Plant Upstream/Downstream Operations
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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Applications are sought for a leadership opportunity in MRL’s Biologics Pilot Plant (BPP). Individual will have the opportunity to manage a group of scientists/engineers in the day to day activities as well as lead campaign(s) focusing on GMP manufacture of bulk biologics (vaccines and therapeutic proteins) clinical supplies. Candidate is expected to work in a team atmosphere in close collaboration with the development groups. Responsibilities include all aspects of preparation, execution, and closeout of a GMP campaign. Candidate will participate in/oversee a range of specific activities including, but are not limited to, equipment specification, equipment start-up, campaign document preparation/review, process fit within the BPP suites, planning and execution of GMP batches, supporting / coordinating cleaning development / validation, and steam-in-place development / validation as well as directly involved with personnel development and mentorship/guidance of staff.
A key element of this assignment is to coordinate the campaign activities with the process development functions, various groups within the Biologics Pilot Plant (BPP operations, GMP/safety, raw material planning) and support areas such as quality engineering, GMP compliance, and facilities support groups. Individual is expected to supervise a small team typically focusing on 1-2 campaign(s) at a time while coordinating the overall campaign activity across a much larger multi-functional team. In addition to the core responsibilities outlined above, an opportunity exists to contribute towards defining/streamlining various business processes for efficiently managing this multi-product facility to manufacture clinical supplies for products in all phases of development.
- A Bachelor's Degree in Chemical Engineering or Biological Sciences with a minimum of 12 years of relevant experience, OR A Master's Degree in Chemical Engineering or Biological Sciences with a minimum of 8 years of relevant experience, OR a PhD in Chemical Engineering or Biological Sciences with a minimum of 4 years of relevant experience.
- Previous significant experience in processing of biologics and/or vaccines and GMP operations.
- Strong technical background in several bio-process unit operations is required.
- Previous experience leading work groups.
- Proven project management skills.
- Strong leadership/management skills and personnel development aptitude
- Excellent organizational and problem solving skills.
- Demonstrates the ability to work independently and/or in a team environment delivering strong results.
- Demonstrates exceptional conflict management and negotiation skills.
- Ability to help to create and define compelling vision, drive change, influence decision making.
- Good understanding of the regulatory guidelines governing cGMP manufacture is critical.
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: Biological Manuf-Pilot Plant
Employee Status: Regular
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Company Trade Name: Merck