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.
Associate Director Chemistry
In Bayer’s Pharmaceuticals division, we focus on researching, developing, and marketing specialty-focused innovative medicines that provide significant clinical benefit and value, primarily in the therapeutic areas of cardiology, oncology, gynecology, hematology, and ophthalmology. With our innovative products, we seek to achieve therapeutic benefit for patients, while at the same time satisfying the growing requirements of physicians and health insurers. As one of the leading research-based pharmaceutical companies worldwide, we have nearly 50 ongoing development projects in clinical trials.
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Associate Director Chemistry, are to:
- Provide definitive technical review of data generated for all purposes, including the manufacture, testing and distribution of commercial and clinical products, and special studies;
- Evaluate the data with respect to potential product impact;
- Ensure conformance to all regulatory requirements, including those of the FDA and various international regulatory governmental bodies;
- Interpret regulatory agency requirements to staff, and guide those personnel as they respond to changing regulatory requirements;
- Interact directly with auditors and inspectors from FDA, other governmental regulatory agencies, and partners and suppliers;
- Own the design of product tracking and trending systems and programs that assist in the testing, evaluation, and monitoring of production quality;
- Guide personnel of various levels as they create, implement, and support those systems and programs;
- Lead and represent the function at operational and cross functional meetings, including discrepancy investigations, and providing technical expertise and disseminating information back to their functional groups;
- Interact with departments related to product and process design, product and process transfer, product manufacture, release and distribution as needed;
- Create, revise, and review documents of all types, including Standard Operating procedures, Discrepancy and Action Reports, written reports of investigations, technical reports, submissions to regulatory agencies;
- Respond to regulatory comments, and validation protocols and reports;
- Establish and maintain streamlined laboratory operations minimizing workload, optimizing resources, streamlining existing systems and ensuring adherence to all appropriate guidance both internally and externally;
- Contribute to continuous improvement opportunities encouraging the submission of simplification ideas;
- Provide leadership for team performance, daily operational activities, safety and environmental compliance with current site, regulatory and Bayer directives;
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor's degree in a Science, Technical or related discipline;
- Knowledgeable of cGMP and regulatory compliance (US and other international agencies);
- Demonstrated practical knowledge and sound understanding of pharmaceutical, biologics, Pharmacopeia requirements and instrumental and wet chemistry analytical techniques;
- Strong leadership, interpersonal, communication and team building skills;
- Ability to multi-task and adapt to changing business requirements in a dynamic corporate environment;
- Minimum 10 years of laboratory experience in pharmaceuticals or a related industry with minimum five years in management positions, or an equivalent combination of education and experience.
Employees can expect to be paid a salary of approximately $105,500 to $158,183. Additional compensation may include a bonus or commission (if relevant). Other benefits include health care, vision, dental, retirement, PTO, sick leave, etc. If selected for this role, the offer may vary based on market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.
Bayer 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.
|IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its employees to be fully vaccinated against COVID-19. Bayer active employees are also expected to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status to Occupational Medicine. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer employees are also required to comply with state, local and customer requirements.|
|Location:||United States : California : Berkeley|