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.

Night Shift - Drug Substance, Manufacturing Shift Lead 

Responsible for leading one of the shift teams within the rFVIII Manufacturing Operations Disciplines. Will act as the Subject Matter Expert for area’s shift activities and drive daily shift operations as required by rFVIII schedule. 

YOUR TASKS AND RESPONSIBILITIES 

The primary responsibilities of this role are to:   

• Leads team in achieving the daily scheduled activities which support short term outcomes and the overall rFVIII mission. Responsible for the shift’s adherence to the schedule. 

• Develops and builds the shift’s capabilities needed to create value for customers and stakeholders. 

• Trains shift and ensures sustainment on site and corporate initiatives such as Dynamic Shared Ownership, Product Supply Pillars, Operation Excellence concepts, etc. 

• Partners and aligns with the other shifts within rFVIII Manufacturing in developing and achieving common goals/90day sprints. Collectively meets or exceeds team goals. 

• Seeks cost savings (VIP) opportunities and is an active participant in the execution plan through completion. Understands department budget and responsible for shift team adherence to the budget.  

• Provide education, coaching and feedback to establish a Quality and Safety team mindset. 

• Coaches team through the problem-solving process. Responsible for leading the team in determining root causes of shift discrepancies and write-offs, implementing effective corrective actions and sharing learnings with other shifts to reduce the department’s deviations and write-offs. 

• Utilizes common tools within rFVIII to evaluate/improve/communicate daily performance. Ensures and responsible for the shift’s PSS and tools, such as shift handover, 24 hr performance dialogue, standard work, pre-job briefs, etc. 

• Supports diversity initiatives. 

WHO YOU ARE 

Bayer seeks an incumbent who possesses the following: 

Required Qualifications: 

• BS with 8+ years of industry experience, or MS with 6+ years of industry experience, or PhD with 4+ years of industry experience, or an equivalent combination of education and experience would be considered.  

• 5+ years of direct manufacturing experience is required 

• Advanced understanding of pharmaceutical operations within API (cell culture and purification), FPM (fill/finish, packaging), QC (environmental and product monitoring and sampling, assays, specification setting), Supply Chain and Warehouse Management, Validation, and Quality Systems (Deviation and CAPA management, Change Control, Audit & Observation management, Risk Management, etc.) 

• Demonstrated experience leading teams and fostering a high-performance culture with the ability to coach, inspire, mentor, attract and develop inclusive teams 

• Proven success transforming change and instilling ownership, trust and accountability 

• Understands the standard budgeting process and resource planning 

• Expert knowledge and experience in Current Good Manufacturing Practices (cGMP) and regulatory requirements (FDA, EMEA, ICH, etc.) 

• Excellent written, verbal, and presentation skills with the ability to adjust presentation style to accommodate various audiences 

• Ability to plan and prioritize complex and conflicting activities on a daily basis. 

• Effectively perform under pressure; anticipate and assess risk and proactively prevent or mitigate issues 

• Demonstrates ability to have a Safety, Compliance, and Continuous Improvement mindset and hold team accountable 

• Experience leading the decision-making process through critical and independent thinking and logical reasoning 

• Knowledge/experience of Microsoft Office Suite (Word, Excel, Outlook & PowerPoint, Teams), SAP, Dev@Com, ValGenesis, PharmDoss, and MES 

Preferred Qualifications: 

• Knowledge/experience applying the Berkeley Site’s current Collective Bargaining Agreement 

This role includes alternating shift work every other week based on the following schedule: 

Week 1 

Days: Wednesday Evening – Sunday Morning (4 Nights) 

Hours: 6pm – 6:30am PST 

Week 2 

Days:  Wednesday Evening – Saturday Morning (3 Nights) 

Hours: 6pm – 6:30am PST 

Employees can expect to be paid a salary between $101,858.00 to $152,787.00. Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..  This salary (or salary range) is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors. 

This posting will be available for application until at least May 5th.