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Reporting to the Executive Director of Process Development and Commercialization (PDC), the incumbent will be responsible for developing and executing a comprehensive strategy leading the department of approximately 16 scientists and engineers in the late-stage development, scale-up and characterization of cell culture and downstream purification processes for Merck's innovative protein therapeutic products (both mammalian and microbial products) and biosimilar product pipeline. The Director of Manufacturing Sciences will be responsible for manufacturing process transfer and support to a Merck commercial manufacturing facility of up to 15,000 L bioreactor scale or to external contract manufacturing organization facilities, providing technical expertise and support for clinical manufacturing, process characterization and performance qualification, commercial launch and manufacturing (L+3) and post-launch process improvements ensuring the scalability, robustness and competitive economics of drug substance manufacturing processes. The incumbent will provide oversight and participate in the management and monitoring of cGMP-compliant contracted manufacturing operations and will work with quality assurance, compliance and regulatory functions to meet project demands and contribute to submissions to regulatory authorities including BLAs/MAAs.
Key job responsibilities include:
§ Provide expertise to, lead and integrate activities of a team of scientists and engineers in support of the development and characterization of state-of-the-art cell culture and purification processes for producing therapeutic protein products with emphasis on fundamental understanding of product interactions and impact of all unit operations;
§ Provide leadership in establishing and implementing manufacturing process characterization methods (QbD / DoE / PAT) and the development of effective scale-down models enabling transfer in and translation of laboratory and pilot-scale processes to clinical and commercial manufacturing scale;
§ Support technical transfer and deliver robust processes and process control strategies that generate products of high quality, are economically viable and are operationally appropriate for the intended manufacturing facility and meet or exceed current regulatory and quality expectations;
§ Working with existing Manufacturing Operations, Quality and Technology management and staff to ensure timely production of phase 3 clinical drug substance;
§ Working with existing operations management to support completion of performance qualification campaigns and product launch; responsibility of Manufacturing Sciences to commercial manufacturing extends through the release of the initial commercial supply campaigns until process and scale-down model robustness is proven (typically 2 - 3 years post launch);
§ Provide subject matter expertise in key regulatory interactions, provide oversight and delivery of necessary technical reports and white papers and author relevant CMC sections of regulatory submissions in support of clinical development and product registration;
§ As a functional area leader, create and foster a vision of scientific and operational excellence, energize staff and foster a culture that is inclusive, developmentally empowered and focused on working collaboratively in an integrated, interdependent community across MMD, MRL and Commercial Operations to meet product development needs;
§ Contribute to the building of a center of excellence with deep expertise in therapeutic protein processing that will catalyze the identification of scientific and technological opportunities to improve upon product cost, process robustness, productivity, and quality compliance.
In support of these key responsibilities, the incumbent will:
§ Develop and maintain a strong collaborative relationship within PDC and BMSC and with other departments including Biologics Technical Operations, BioProcess Development (Merck Research Laboratories (MRL) early-stage process /analytical / formulation development team) and Merck quality and regulatory organizations;
§ Partner with MRL for technology transfer of drug substance manufacturing processes developed by MRL or with technical transfer teams for in-licensed development candidates into the phase 3 manufacturing facility - in all cases, the phase 3 manufacturing facility is intended to transition to the final commercial manufacturing facility;
§ Coordinate with the Biologics Technical Operations group to identify opportunities for improving existing processes with a focus on leaning processes and continuously improving COGS - responsible for laboratory-based project work in support of process improvements that will require regulatory/licensing approvals;
§ Provide leadership in the innovative development of new gene expression, cell culture, and purification technologies and process platforms from early process development strategies through commercial product launch and partner with MRL regarding new manufacturing technology and implementing that technology in commercial manufacturing facilities (e.g., single-use technology);
§ Act as a liaison between the company and external clients, partners or potential partners, and occasionally, serve as the primary contact between Merck and its 3rd party collaborators with regard to the manufacture of biopharmaceutical products, implementation of the project timelines, and participation in the definition of supply forecasts for supply agreements;
§ Ensure the effective management and administration of the departmental budget, headcount, assets, and expenses;
§ Be responsible for the recruiting, training and development of Manufacturing Sciences staff;
§ Maintain overall responsibility for the organization achieving its departmental compliance objectives, including safety, environmental, quality and business compliance obligations.
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