Bayer Prin Product Specialist in Berkeley, CA, California
Your tasks and responsibilities
Position purpose: API Cell Bank and Expansion subject matter expert capable of leading the production process, overseeing the cell bank management process, and making technical and compliance decisions independently.
Major tasks and responsibilities of position (max. 8 key topics) 1) Leads and executes rFVIII-FS, rFVIII-PF, and rFVIII-N manufacturing operations (cell bank management, cell expansion and bioreactor operations) under cGMP conditions. 2) Provides technical expertise as a process (Cell Bank Management) SME and influences technical and compliance decisions. 3) Drives and maintains departmental Production Supply System to achieve suitable operational standards, operational excellence methods and tools, performance culture, mindset and Behavior. 4) Creates, owns, reviews and revises controlled documents such as SOPs, electronic batch records, change applications, risk assessments, process descriptions, validation protocol, qualification reports and etc. 5) Participates in deviation investigations. Collaborates with cross-functional departments on root cause identifications and appropriate corrective action assignments. 6) Prepares for and participates GMP and safety inspections. 7) Trains, mentors and coaches peers/colleagues in area of expertise. Responds to on-floor technical emergencies. 8) Oversees departmental project portfolio; Responsible for appropriate project task assignments and executions.
Who you are
Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, and Efficiency) values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Qualifications: BS in science, engineering or equivalent BS 8+ years MS 2-6+ years PhD 0-4+ years of experience in a regulated cGMP pharmaceutical/biotech operations/manufacturing environment and experience in cell biology, tissue cell culture or an equivalent combination of education and experience 1. Knowledge of and experience with mammalian cell culture and cryopreservation. Experience with cell bank management and testing requirements. 2. Experience with regulatory and cGMP requirements for pharmaceutical manufacturing. 3. Understanding of business process management (bpm) principles and uses bpm effectively. 4. Experience and Knowledge of Microsoft Office, Outlook, Visio, Microsoft project, and web search engines. 5. Strong analytical skills to identify root causes and prepare balanced decisions. 6. Excellent verbal and written communication skills. 7. Experienced in effectively training manufacturing personnel. 8. Excellent influencing skills. 9. Excellent ability to communicate with cross-functional partners compliance requirements and meet production goals. 10. Applies team effectiveness skills and contributes actively to the achievement of department KPIs and objectives. 11. Treats colleagues from all levels as internal customers. Interacts and responds to requests respectively. 12. Is able to expand the fundamental knowledge of the position and broaden own skills.
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. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled