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Senior Manager, Analytical Development
4 months ago
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.Senior Manager, Analytical Development - Operations, Compliance & Clinical Supplies Senior Manager, Analytical Development – Operations, Compliance & Clinical Supplies PURPOSEThe Senior Manager, Analytical Development (AD) Operations, Compliance and Clinical Supply , with some supervision from the Analytical Development Management, leads all analytical activities for the assigned task(s). This includes management of the analytical work that supports clinical trials and consumer studies, including product release and stability study management. Collaborates with all internal and external functional teams. The role also leads the raw material (RM) activities to support product development. The incumbent helps, as needed, the Analytical Development team to manage stability programs, reference standard certification, method evaluation, method validation, method transfer, etc. The Senior Manager ensures all tasks and documentation are completed in time, in compliance and accurate, and all activities are documented at a high quality. YOUR TASKS AND RESPONSIBILITIESThe Senior Manager is responsible for:Leading and managing all the clinical/consumer study AD activities, such as generating specifications, managing testing, and preparing CoAs to support product shipment on time and meet all GMP requirements;Leading GMP stability activities to support clinical/consumer studies. It includes creating stability plan, preparing stability protocol, managing stability sample pulls and testing, coordinating withCSG on closing memo and managing final stability report;Managing 3rd party activities associated with clinical supplies such as requesting quotes, generating work orders, arranging samples etc.;Supporting GMP raw material procurement, quality release activities;Coordinating with project teams and stakeholders to determine the project RM needs; supporting analytical activities such as critical review and approval of RM specs and CoAs. Compiling and organizing all technical documentation related to raw materials, managing inventory;Ensuring the timelines are met according to Project requirements;Supporting GMP Operations AD activities (e.g., water quality report, documentation review, training etc.);Managing Change Controls, Deviations, CAPAs and Quality Events in CS/RM/Metrology related objectives;Drafting and reviewing SOPs and OIs for Analytical Development.WHO ARE YOUBayer is seeking an incumbent who processes the following:REQUIRED QUALIFICATIONSBachelor’s Degree in Science, or international equivalent with 8 or more years of proven experience OR a Master’s degree in Science, or international equivalent, with 6 or more years of proven experience;High level of experience in the areas of clinical/consumer study in analytical support and raw materials;Expert knowledge in clinical/consumer product release requirements and concurrent stability management, and RM quality management;Excellent oral and written communication (emphasis on clear and concise);Excellent organization skills, multiple task management skills, leadership skills to solve issues from vendors and internal requests.PREFERRED QUALIFICATIONSPreferred experience in LIMS usage;Preferred experience in raw material procurement. YOUR APPLICATIONBayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.Bayer is an E-Verify Employer.Location:United States : New Jersey : Morristown Division:Consumer Health Reference Code:821439Contact UsEmail:hrop_usa@bayer.com
