Merck Senior Director Microbiology COE in West Point, Pennsylvania
If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law
The Senior Director, Microbiology is accountable for providing strategic and technical leadership supporting the small molecule, biologics, and vaccine candidates in the clinical development space across the our Research & Development Division microbiology network (site based teams in Rahway NJ, West Point PA, WAG Switzerland and Dunboyne Ireland at developing BioNX Facility). This includes not only oversight of the execution of GMP release and stability activities supporting the development pipeline, but facility environmental monitoring, and oversight of analytical method transfer from the embedded microbiology development team, transfer support to commercial sites and supporting regulatory filings including INDs/IMPDs and BLAs. This team is also responsible for evaluation and implementation of new analytical technologies, including continued development and execution on rapid microbiology methodology implementation.
Strategic partnering with Analytical Research and Development teams, Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential. The incumbent will also be key in partnering across our Microbiology Network, both within our research site based microbiology teams, and strategically across our network with the Microbiology COE and commercial sites to ensure line of sight to analytical transfers and with industry forums and regulatory partners to drive forward looking strategies. The Senior Director will also have oversight of all raw material testing, and IPC analysis, and aligned methodologies for all critical quality attributes tested on process intermediates.
The Senior Director reports to the Associate Vice President of Small Molecule Analytical Research and Development and will be directly responsible for a team of approximately 25 internal and external scientists. The position is accountable for delivering phase-appropriate qualification/validation, verification of compendial microbiological and IPC assays, execution of on-time release, stability and environmental monitoring, partnering with interfacing teams to transfer and implement forward looking analytical technologies and innovative approaches, and GMP execution with the highest scientific standards. The incumbent will be responsible for managing area status and GMP readiness, providing oversight for equipment readiness, oversight of documentation systems, authoring, reviewing and approving of GMP documentation, review and approval of site and global SOPs, including oversight of the departmental SOP system, oversight of change management documentation, investigations and corrective action plans, oversee training plans and documentation and facilitation and participation in on-site audits and inspections.
The successful candidate must function well and be able to partner in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including strong background and experience in microbiological and analytical chemical techniques, project and team management and publication of research results. The incumbent will be responsible for the recruiting, appraisal and development of personnel under her/his supervision. The Senior Director selects, trains, and effectively works with colleagues to action development plans of personnel under her/his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and promotion planning). Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and alliance with various partners and stakeholders in development.
Education Minimum Requirement:
- Ph.D. in microbiology or related field with 8+ years of relevant experience in the pharmaceutical industry; MS with 10+ years of relevant experience; BS with 14+ years of relevant experience in the Pharmaceutical Industry.
Excellent verbal and written communication skills in English and preferred business-proficient to fluent in German, demonstrated creativity, strong interpersonal and collaborative skills
Demonstrated ability in leading cross-functional groups with proven talent development skillsets.
Ability to work in a team environment with cross-functional interactions is essential
Strength in delivering results on firm deadlines in support of compound from development through commercialization
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., Kenilworth, 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 …
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 .
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Requisition ID: R144377