Executive Director, Biologics Process Development
In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.
The Executive Director, Biologics Process Development is accountable for driving industry-leading innovations in bioprocess that are implemented to enable world class commercial processes for new products at first filing. The scope of this operation includes laboratory-based bioprocess innovation through prep-lab and pilot plant demonstration and partnering across Development Sciences and Clinical Supply (DSCS) and our Manufacturing Division colleagues to complete process characterization, technology transfer to commercial manufacturing sites and authoring of regulatory filing submissions.
Reports to the head of Biologics Process, Research and Development (BPR&D). The department head participates in network wide activities within BPR&D for setting strategic direction, prioritizing allocation of resources and managing budgets to align actions with strategy.
Supervises 3 - 4 leaders and through them, approximately 35 biologists and engineers who work closely within multidisciplinary teams. Responsible for the appraisal and development of personnel under their supervision. Selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under thier direction within the framework of Company policy.
Accountable for driving innovations in drug substance process development for biologics pipeline programs. Strong capabilities in managing progressive timelines, program risks and mitigation strategy. Strong knowledge and experience in bioprocess development, scale-up, technology transfer, and process characterization. In-depth knowledge in upstream cell culture process development, to support bioprocess platform and technology development. The incumbent must excel in leading the conduct of scientific research, both at laboratory and plant scale; translating breakthroughs in fundamental science to afford world class process for biopharmaceuticals. Oversight of the non-clinical drug substance budget as well as any internal activities related to supply of GMP DS for the support of early clinical and preclinical development.
A successful incumbent will excel in collaborating with partner groups within Process R&D, Manufacturing Division, and Regulatory CMC, to ensure new commercial manufacturing processes successfully transfer to manufacturing sites in preparation for first commercial filing and assist in the authoring of regulatory filing submissions for commercial products. Collaborates and influences both technically and strategically the capabilities of the DS network inside the company and with key partners.
Directs the preparation of and approves disclosures prepared within their department to be used as the basis for patent applications.
Establishes, recommends, and maintains for R&D external contracts, including grants, fellowships, and consultants in expressed fields of activity. Is expected to cultivate strong relationships with key opinion leaders and top academics in their field.
Ph.D. in biology, biochemistry, chemical engineering or related pharmaceutical science is required.
Required Experience and Skills:
10+ years drug substance experience and demonstrated ability in leading a research team.
Demonstrated leadership in driving scientific excellence; translating breakthroughs in fundamental science to afford world class biologics manufacturing processes
Must have excellent interpersonal, communication, and collaboration skills and strength in delivering results on firm deadlines.
Must be recognized in the pharmaceutical industry, through publications/presentations, for subject matter expertise.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
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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.
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Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:$191,700.00 - $326,000.00
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Flexible Work Arrangements:Not Specified
Shift:1st - Day
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