Our Company's Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to be the most trusted supplier of biologics, vaccines, 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.
As part of the Our Company Manufacturing Division within Manufacturing Systems Design and Commercialization (MSDC), the Biologics Process Development and Commercialization (BPDC) department provides the technical process leadership and laboratory capabilities in support of late stage pipeline and commercial drug substance manufacturing processes for biologics (therapeutic proteins). For pipeline programs, BPDC supports various commercialization activities, including technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. For commercial programs, the scope includes site-to-site process transfers, manufacturing investigation and trend evaluations, process enhancements, next generation process (i.e., post approval) development and characterization, process validation, and regulatory submission authoring.
Reporting to the Executive Director in Downstream and Process Analytics, this individual will support late stage and commercial biologics programs with a focus on downstream processing. The individual will demonstrate a deep scientific understanding of the product and the process sciences, and will have broad, experience-based skillsets in both large-scale manufacturing sciences and in applicable business processes required for the scope of BPDC activities, including influencing technical direction at Our Company.
- Leads downstream and/or overall drug substance teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.
- Manages and/or mentors junior staff in the Downstream group. Empowers and develops employees to build strong collaboration and find patient focused solutions.
- Drives division wide initiatives that will enable Merck’s biologics manufacturing strategic goals, in areas such as supply chain design, advanced/flexible manufacturing formats, and data digitization/democratization.
- Provides technical leadership for laboratory-scale and manufacturing scale studies to support commercial process validation, characterization, and deviation/trend investigations, including studies performed either in-house or externally.
- Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, analytical, and GMP site readiness.
- Builds and establishes internal and external networks to identify solutions to technical and business problems. Represents functional area on cross-functional and cross-divisional teams.
- Authors and reviews required regulatory and technical documentation.
Education Minimum Requirement:
BS, MS or PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 14 years (for BS), 12 years (for MS), or 8 years (PhD) relevant experience.
Required Experience and Skills**:
- Proven track record of biologics drug substance commercialization and manufacturing science & technology, technology transfer expertise for monoclonal antibodies.
- Experience in downstream processing and process control strategies and working knowledge of upstream & analytics.
- Proven ability to drive Innovation.
- Excellent oral and written communication skills. Demonstrated ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.
Preferred Experience and Skills:
- In-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.
- Prior experience in late stage process development, process characterization including viral clearance studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.
- Working knowledge of statistical methods for DOE design, statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.
- Working understanding of analytical methods to characterize biologics and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus.
- Demonstrated experience in lean leadership/operational excellence with applicability to functional area (e.g. labs) or manufacturing processes.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
Our Company., Inc., Kenilworth, New Jersey, USA is known as “Our Company” in the United States, Canada & Puerto Rico. We are known as “Our Company” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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