Bayer Sr Manager Transfers Specialist Project in Berkeley, CA, California
Your tasks and responsibilities
Bayer seeks high energy leaders ready to help shape the future by confronting new challenges, embracing new experiences and taking on increasing responsibilities.
Provides leadership, management, and technical oversight for the successful validation, verification, and transfer of commercial analytical methods for biologic pharmaceuticals, and raw materials to global sites for testing, and commercial launch. Oversees the progress of product related projects within the QCAC organization and ensures that the departmental goals and metrics are met. Responsibilities include but are not limited to validation and transfer activities, regulatory support, process improvements, team and people building.
More specifically related to this role, the incumbent will have responsibilities to include, but not limited to:
This position is responsible for:
• Lead technical transfer of analytical methods for biologics and raw materials to global, internal and external sites in line with Bayer directives, ICH guidance, and global regulations. Design, manage, and provide oversight of transfer activities. • Write and review and/or provides direction and guidance to authors of analytical method validations and transfer protocols and reports; and evaluate data generated from these activities. Oversee the generation of reports for invalid events; and other departments metrics; Authors and reviews SOPs, technical registration documents and other sections of regulatory submissions. • Evaluate, reduce, manage and communicate risks associated with transfers. Establish new, and improve existing processes for transfer ensuring cross functional alignment with stakeholders across sites. Identify opportunities to reduce costs and operate more efficiently, and make recommendations to management. • Provide strategic and technical guidance and management support for method transfer related discrepancies, corrective and preventative actions and change control. Collaborate effectively with Global Biological Development, QC and QA to manage the initiation, evaluation, and closure of discrepancy events. • Support inspections and audits from internal Bayer functions, external partners and health authorities. Collaborate cross functionally and build relationships with internal stakeholders within QCAC, QC Microbiology and Virology QA, and Global Regulatory Affairs, Global Biological Development, Quality Engineering and with external customers to streamline processes across the organization, implement improvements, and facilitate communication. • Manage multiple projects, set priorities, and work in a fast paced environment. Serve as an SME. Be able to negotiate, influence, and work in a matrix environment and across sites. Represent the organization at outside analytical methods validation and transfer Benchmarking groups, or consortiums. • Stay current with new regulations especially for method validation and analytical transfer requirements. • Ensure personnel are properly trained and adhere to their training plans; ensure compliance with programs and adherence to cGMP, health and safety requirements and environment protection initiatives. • Provide effective leadership including, individual goal setting performance reviews, managing the development of employees, mentoring, recognizing employee contributions, motivating, mitigating conflict and communication problems, planning and facilitating team activities, and supporting workforce diversity and quality.
Who you are
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, and Efficiency) values. Related to this position, we are seeking an incumbent who possess the following: The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:
Bachelor's Degree in a science or technical field. M.S, Ph.D. preferred 8-10 years of experience in pharmaceuticals or a related industry with 4-6 years in management positions. Or, an equivalent combination of education and experience.
• Strong leadership, interpersonal, communication, team building and project management skills. A leader with energy, interest and passion for the job at hand. • Knowledge of cGMP and regulatory compliance (US and other international agencies). • Experience with analytical methods validation and transfers management and data evaluation per ICH guidelines. • Experience with stability indicating analytical methods such as chromatography, potency assays, gel electrophoresis and binding assays. • Experience in drug development spanning early to late development. • Experience with LIMS, SAP and statistical data analysis and trending software for e.g. JMP. • Ability to multi-task and adapt to changing business requirements in a dynamic corporate environment with demonstrated track record of completing projects on time.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. .
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled