rFVIII Drug Product Team Lead - Berkeley, CA

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rFVIII Drug Product Team Lead - Berkeley, CA

As an rFVIII DP Team Lead, you lead the rFVIII Drug Product work team with accountability for cGMP-compliant manufacturing operations, ensuring adherence to quality systems, regulatory requirements, and standard operating procedures; You provide subject matter expertise for rFVIII Drug Product processes and support the successful execution of tech transfer activities to a Contract Manufacturing Organization (CMO), including process knowledge transfer, compliance alignment, and operational readiness; You play a pivotal role in connecting manufacturing excellence with strategic tech transfer, partnering closely with cross-functional and external stakeholders to ensure reliable supply of high-quality therapies for patients worldwide.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, rFVIII DP Team Lead, are to:

• Lead the rFVIII Drug Product work team by setting clear operational priorities, removing barriers, and ensuring consistent delivery of production objectives in a cGMP-compliant environment;

• Serve as subject matter expert for rFVIII Drug Product operations, supporting internal and external regulatory inspections and leading process and knowledge transfer activities during technology transfer to the CMO;

• Ensure effective resource planning and execution in collaboration with Home and Shift Leads, aligning staffing, production schedules, and project timelines to meet manufacturing and business objectives;

• Drive manufacturing performance and reliability through routine review of DOP and OEE metrics, identifying root causes and implementing sustainable performance and reliability improvements in partnership with Maintenance and Engineering;

• Safeguard adherence to quality systems and regulatory requirements by promoting robust cGMP compliance, including deviation management, CAPA, change control, and ongoing inspection readiness;

• Support financial and operational performance by driving cost of goods improvements, advancing value improvement projects, and identifying sustainable cost optimization opportunities;

• Lead and sponsor key operational and strategic initiatives, including site and corporate programs (such as DSO, Product Supply Pillars and Operational Excellence), partnering cross-functionally to execute priorities and continuous improvement efforts;

• Build a high-performing, inclusive team culture by fostering safety, quality, engagement and belonging, while supporting employee development and participation in site and community initiatives.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor's degree in a relevant scientific or engineering discipline or an equivalent combination of education and experience;

• Demonstrated experience in pharmaceutical or biotech manufacturing operations in a cGMP environment, preferably in sterile fill/finish or drug product operations;

• Proven experience leading teams in a highly regulated manufacturing environment;

• Demonstrated site presence and responsiveness in an office-based role requiring regular on-site support at the Berkeley facility to enable manufacturing operations and project execution, including the ability to respond to business needs on short notice;

• Proven sterile manufacturing and aseptic expertise, including deep knowledge of aseptic techniques, environmental controls, contamination control strategy and visual inspection requirements to ensure product quality, regulatory compliance and successful technology transfer to a CMO;

• Strong technical expertise in fill/finish equipment and systems, including filling lines, lyophilizers, VHP systems, sterilizers, ALUS, capping systems and associated utilities;

• Broad understanding of end-to-end pharmaceutical operations, including API (cell culture and purification), fill/finish and packaging, QC testing and environmental monitoring, supply chain and warehouse operations, validation and quality systems (such as deviation and CAPA management, change control, audit management and risk management);

• In-depth knowledge of cGMP requirements and global regulatory expectations (for example FDA, EMA/EMEA and ICH), including inspection readiness and compliance during internal and external audits;

• Experience with Product Supply Systems and continuous improvement methodologies (such as Lean, DSO and Operational Excellence), with a track record of driving performance improvements and sustaining results;

• Demonstrated financial and project management acumen, including experience in budgeting, cost management and resource planning, as well as proficiency with project management tools and methodologies to support complex initiatives such as tech transfer;

• Strong leadership and influencing skills, with the ability to build effective partnerships, influence stakeholders (including on challenging or non-aligned positions) and enable team-level decision-making within a highly regulated environment;

• Excellent written, verbal and presentation skills, with the ability to tailor messaging to diverse audiences, including senior leadership, regulatory agencies and external partners such as CMOs;

• Proven people leadership and development capabilities, including coaching and mentoring skills, with the ability to build inclusive, high-performing teams, foster engagement and support employee growth and development;

• Consistent demonstration of a safety-first and quality-first mindset, with a focus on compliance, risk mitigation and continuous improvement;

• Proficiency in relevant systems and digital tools, such as Microsoft Office, SAP, MES, ValGenesis, PharmDoss, View email address on click.appcast.io or equivalent manufacturing and quality systems;

• Ability to meet occupational and physical requirements associated with a manufacturing environment.

Strongly Preferred Qualifications:

• Bachelor's degree with extensive (typically 12+ years) relevant pharmaceutical or biotech manufacturing operations experience, including direct manufacturing experience in a cGMP environment, preferably in sterile fill/finish or drug product operations; or a master's degree with significant (typically 10+ years) relevant experience; or a Ph.D. with substantial (typically 6+ years) relevant experience;

• At least 5 years of progressive experience leading teams;

• Prior experience working in a unionized manufacturing environment and applying a Collective Bargaining Agreement in day-to-day operations;

• Experience supporting or leading tech transfer activities, including direct interactions with CMOs;

• Working knowledge of the Berkeley site Collective Bargaining Agreement and its practical application in a unionized setting;

• Demonstrated application of VACC leadership principles (Visionary, Architect, Catalyst, Coach) by showing self and system awareness, seeking and providing feedback, applying strategic thinking and business insight, focusing on high-impact outcomes, collaborating with accountability, co-creating customer-centric solutions, acting with agility in iterative cycles, leading inclusively and authentically and aligning talent and capabilities to business priorities.

Employees can expect to be paid a salary between $154,640.00 - $231,960.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.

This salary 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 6-16-26.

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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 Health for all, Hunger for none, 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.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.

Bayer is an E-Verify Employer.

Location: United States : California : Berkeley

Division: Pharmaceuticals

Reference Code: 873309

Contact Us

Email: View email address on click.appcast.io