Associate Principal Scientist, Upstream, Biologics Process Development and Commercialization
- Kenilworth, NJ
Our company, 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 our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being 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 our Manufacturing Division, within Global Vaccines and Biologics Commercialization, the Biologics Process Development and Commercialization department provides the technical process leadership and laboratory capabilities in support of late stage pipeline and commercial manufacturing processes for biologics (therapeutic proteins). For pipeline programs, we support 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 investigations and trend evaluations, process enhancements, next generation process (i.e., post approval) development and characterization, process validation, and regulatory submission authoring.
Under the general scientific and administrative direction of the Director in Upstream Commercialization and working in conjunction with internal and external partners, this individual will support these late stage and commercial biologics program activities, focusing on upstream processing. We are seeking an energetic individual with strong scientific, collaboration, communication and interpersonal skills, including capability for team leadership and mentoring of junior staff, for this role.
- Participates in and/or leads cross-divisional technical teams focusing on late stage clinical process development, characterization, and technology transfer and validation with line-of-sight for licensure and commercialization.
- Responsible for laboratory-scale and manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. Provides technical leadership for the design of experiments, data analysis and interpretation, as well as management of external laboratory activities and/or mentoring of junior staff in the execution of internal laboratory activities.
- Provides technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness
- Primary focus will be on upstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including downstream processing, analytical, and site readiness.
- Actively interacts with internal and external counterparts. Represents functional area on cross-functional and cross-divisional teams.
- Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to standard company practices.
Education Minimum Requirement:
- BS, MS or PhD in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 10 years (for BS), 8 years (for MS), or 4 years (PhD) relevant experience.
Required Experience and Skills:
- Technical expertise in mammalian cell culture process development, process characterization and scale-down bioreactor models for upstream cell culture processes.
- Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture.
- Solid experience in using statistical tools (JMP, Design Expert, Spotfire, SIMCA, etc.) for data mining, data analysis, DoE design and modeling.
- Excellent oral and written communication skills. 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 mammalian cell culture for the production of biological molecules required, experience in perfusion processes, harvest and primary recovery unit operations (centrifugation, depth filtration), media/feed development and raw materials understanding is desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.
- Technical operations experience in the manufacture of biological molecules at the pilot- and/or commercial-scale is a plus.
- Prior experience in process performance qualification and validation, site readiness, batch record reviews, and/or working with external contract organization for development and or manufacturing.
- Experience supporting/writing regulatory filings (IND, BLA), responding to regulatory questions and inspections with multiple agencies (FDA, EMA, JNDA).
- Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) 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.
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.
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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