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 $88,651 to $132,977. 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.
YOUR APPLICATION
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.
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.
Bayer is an E-Verify Employer.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Location: United States : California : Berkeley
Division: Pharmaceuticals
Reference Code: 842629
Contact Us
Email: hrop_usa@bayer.com
Job Segment: Compliance, Pharmaceutical, CAPA, Night, Operations, Legal, Science, Management
