Director, Vaccines Analytical Research & Development ( MERCUSR130304ENUS)
The Director, Analytical Research & Development is responsible for providing strategic and technical leadership for Good Manufacturing Practice (GMP) analytics at our West Point PA Facility for vaccines candidates in the clinical development space. This includes not only oversight of the execution of GMP release and stability activities supporting the vaccines development pipeline, but also oversight of analytical method transfer from development labs, interfacing with external partners, and supporting regulatory filings including Investigational New Drugs/ Investigational Medicinal Product Dossiers (INDs/IMPDs) and Biologics License Applications (BLAs). This position includes strategic partnering with process research and development in the development of DS and DP process development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in commercialization and manufacturing.
The Director reports to the Executive Director, Vaccines Analytical Research & Development and will be directly responsible for a team of 10-15 senior and associate level scientists. The position is accountable for delivering phase-appropriate qualification/validation, execution of on-time release and stability, partnering with development 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 collaborate 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 analytical science and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. The incumbent will be responsible for the recruiting, appraisal and development of personnel under her/his supervision.
The 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 collaboration with various partners and stakeholders in development.
Excellent verbal and written communication skills, 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
Ph.D. in analytical chemistry 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.
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.
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.
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