Current Available Positions
Director, Biologics Analytical Sciences - Tri-State
Director, Biologics Analytical Sciences
Reporting to the Executive Director of BMSC, the incumbent will be responsible for building and leading the Biologics Analytical Sciences organization. Key job responsibilities include: Leading and managing a group of scientists that will define and manage the analytical development, method transfer and quality control functions in support of in-process, release and stability testing of drug substance and drug product for multiple late-stage biopharmaceutical development programs; will provide oversight and participate in the management and monitoring of cGMP-compliant contracted manufacturing and product and stability testing activities; and will work with quality assurance, compliance and regulatory functions to meet project demands and contribute to submissions to regulatory authorities including BLAs/MAAs.
Position Responsibilities: • Lead and manage the overall scientific, technical and operational efforts of a group of analytical scientists with delivery of analytical testing strategy and methods, timely data review and oversight, and process knowledge needed to meet the company's development program milestones. • Build a center of excellence with deep expertise in characterization and analytical testing of therapeutic proteins to aid in the identification of scientific and technological opportunities to improve upon product testing strategy, method robustness, analytical testing productivity and quality compliance. • Supervise and guide development/optimization of analytical methods for testing and characterization of biopharmaceutical products, including biochemical assays, HPLC, CE, electrophoretic and immunochemical methods and methods related to drug product safety. • Collaborate, guide and influence assay development team members (internal and CRO/CMO-based) during development of new methods, method optimization and feasibility studies. • Manage method transfer and preparation and approval of SOPs, validation protocols and method validation reports; review and revise SOP's; review and contribute to regulatory filings. • Monitor analytical deviations/OOSs, lead laboratory investigations and participate in manufacturing-related investigations. Proactively incorporate learnings to improve and influence method development and optimization. • Perform on-site representation (person-in-the-plant) during testing of drug substance/product. • Manage and guide drug substance/product stability programs and drug product expiration/retest date notifications. • Responsible for primary contact with CROs/CMOs responsible for in-process, release and stability testing and bioanalytical testing in support of manufacturing development, production, preclinical and clinical activity. • Expected to participate in strategic leadership of the management and control of document/records for GMP and GLP operations. Qualifications Position Requirements: • Ph.D. in a scientific discipline, i.e. biology, chemistry, engineering, etc. and at least 12 - 15 years experience in the biotechnology/pharmaceutical industry, including at least 6 - 8 years experience involving quality control laboratories in a facility manufacturing clinical drug substance and/or drug product for US and/or EU studies. • Ability to lead multiple company programs many with multisite testing strategies. • Strong project management and negotiating skills. • Thorough knowledge of biochemistry, bioassay and microbiological methods and associated instrumentation; knowledge of protein stability assessment. • Experience in validation and transfer of methods used for characterization of biological products. • Working knowledge of current Good Manufacturing Practices (cGMPs) for the US and EU, Good Laboratory Practices (GLPs), and ICH guidelines as they relate to testing and characterization efforts for late phase clinical and commercial drug supply and/or biopharmaceutical production. • Ability to prioritize and successfully manage complex and competing projects. • Excellent communication and organizational skills. • Experience interacting with contract manufacturers and/or partners and ability to interface with collaboration partners to resolve issues rapidly. • Ability to proactively mitigate quality/regulatory risks. • Must have the leadership skills to drive change; the successful candidate will have a high energy level, strong organizational management skills, and possess the ability to influence and collaborate internal and external to Merck. Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Please contact firstname.lastname@example.org for more information about this position.
Quality Assurance/Quality Control: Director Quality Compliance
Location: North Carolina
This New Leader is critical to proactively integrate the Quality Compliance functions to all the activities associated with Product Transfers to a new facility. This leader will assure BOH inspection readiness, product license conformance for the Durham site. This new leader reporting to the Site Quality Head, will provide governance, will establish and maintain managerial process all activities related with facilities and product licensing as well as all regulatory communications with FDA, EM...