Principle Analytical Scientist / Biologics Analytical Sciences Job Job in West Point, Pennsylvania US
Principle Analytical Scientist / Biologics Analytical Sciences Job
Principle Analytical Scientist / Biologics Analytical Sciences-PRO009265 Description Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Reporting to the Senior Director / Director / Associate Director of Biologics Analytical Sciences, the incumbent will be responsible for managing 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 1 - 2 late-stage biopharmaceutical development programs; will 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. Responsibilities include: * Supervise 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 closely with 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; contribute to regulatory filings. * Monitor analytical deviations/OOSs, lead laboratory investigations and participate in manufacturing-related investigations. * Perform on-site representation (person-in-the-plant) during testing of drug substance/product. * Manage drug substance/product stability programs and drug product expiration/retest date notifications. * Where appropriate, serve as primary contact with Contract Research Organizations (CROs)/Chief Medical Officers (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 the management and control of document/records for GMP and GLP operations. Qualifications Education: * Ph.D. in a scientific discipline, i.e. biology, chemistry, engineering, etc., with a minimum of 3 years experience in the biotechnology/pharmaceutical industry, including at least 1 - 2 years experience involving quality control laboratories in a facility manufacturing clinical drug substance and/or drug product for US and/or EU studies; or * B.S. in a scientific discipline and a minimum of 6 years experience in the biotechnology/pharmaceutical industry, including at least 2 - 3 years experience involving quality control laboratories in a facility manufacturing clinical drug substance and/or drug product for US and/or EU studies Required: * 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 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 * Ability to proactively mitigate quality/regulatory risks * Motivated team player with proven leadership abilities 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. merck.com/careers to create a profile and your resume for requisition # PRO009265. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Primary Location: US-PA-West Point Employee Status: Regular Travel : Yes, 10% of the time Number of Openings: 1 *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Merck prefers that you apply to this job directly on their site