Requisition ID: PRO018911
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 late stage process development, technology transfer, and in-line support of vaccine products. We seek an energetic, people-oriented leader with strong scientific and technical skills to lead the development and commercialization activities supporting multiple vaccine programs. In this role, you will be responsible for:
- Leading process development activities to execute large molecule downstream processing including lab-scale process development and optimization, in-process assay support, and process scale-up/scale-down.
- Execution of lab-scale experiments and authoring associated technical reports and documents.
- Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing.
- Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner.
- Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.
- Provide mentorship and technical direction to other members of the team which may include dotted-line reporting relationships.
Education Minimum Requirement:
- B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field plus 6 years of relevant experience
- Master's degree plus 4 years of relevant experience
- Ph.D. with relevant academic experience.
Required Experience and Skills:
- Large and/or Small molecule purification
- Lab scale experimental execution, statistical data analysis, presentation of results/conclusions, and the application of principles/theory into process design and practice.
- Experience authoring technical documentation.
- Experience with project strategic planning.
- Outstanding communication and people skills.
- Ability to foster a collaborative work environment focused on mentorship,coaching, and Subject Matter Expert development.
Preferred Experience and Skills:
- Hands-on expertise in execution of process development with multiple programs and unit operations
- Large molecule drug substance process development, scaling (up and down) and tech transfer
- cGMP experience.
- Analytical method execution or development.
- Experience with Design of Experiments (DOE).
- Experience with Quality by Design (QbD) and Lean Six Sigma principles.
- Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.
- 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 with on-the-floor GMP manufacturing support.
- Expertise in data visualization and working with large database sets.
- Experience with the following softwares: JMP, Spotfire, PI ProcessBook, or similar.
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 firstname.lastname@example.org .
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Visa sponsorship is not available for this position.
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Job: Process Engineering
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: access to areas working on Biosafety-level 2 organisms, working with hazardous chemicals (phenol, among others)
Company Trade Name: Merck
Nearest Major Market: Philadelphia