Role Summary
The Plant Manager for Biologicals is responsible for the overall leadership, operational excellence, and strategic direction of the manufacturing site. This role will ensure the safe, compliant, cost-effective and efficient production of biological products in alignment with USDA regulatory standards, corporate strategy, and financial targets.
Key Role Specific Responsibilities
1. Strategic & Operational Leadership
- Develop and execute site strategy aligned with global biological business objectives and ensuring the site's capabilities evolve to meet future portfolio and technology needs
- Drive operational excellence, digital transformation, and continuous improvement
- Lead capacity planning and long-term investment strategy to ensure supply commitments are met
2. Manufacturing & Technical Operations
- Oversee end-to-end manufacturing (upstream, downstream, fill/finish, packaging)
- Maintain a high level of equipment reliability, facility readiness, and technical capability
- Champion process robustness, validation and technology transfers through the use of KPI's
- Support technology transfers, new product introductions, and collaborations with R&D and the commercial team
3. Quality & Compliance
- Promote a strong quality culture of compliance and data integrity
- Partner closely with Quality leadership to ensure audit readiness and successful regulatory inspections
- Ensure timely resolution of deviations, CAPAs, and quality issues are effectively implemented and verified
- Ensure compliance with USDA regulatory requirements, allowing the site to be operated at a constant state of inspection readiness
4. Financial & Business Management
- Provide full P&L ownership for the site
- Lead capital investment planning for facility upgrades, expansions, and new technologies
- Manage site budget, capital expenditure, and cost optimization initiatives
- Optimize resource allocation, productivity, and operational efficiency
5. People & Culture
- Lead, develop, and inspire a high-performing, cross-functional team
- Build succession plans and talent development strategies to maintain strong employee engagement
6. Stakeholder & External Engagement
- Act as the primary site representative to corporate executives, regulators, partners, and local authorities
- Represent the site in global network forums and strategic decision-making bodies
7. EHS & Risk Management
- Ensure compliance with environmental, health, and safety regulations
- Promote a zero-injury safety culture and ensure compliance with EHS regulations
- Oversee risk management programs, biosafety controls, and emergency preparedness for business continuity and risk mitigation planning
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
Competencies Required for the Role
COMPLEXITY/STRESS MANAGEMENT/TIME MANAGEMENT - The ability to keep functioning effectively when under pressure and maintain self-control in the face of hostility or provocation. Cuts through complexity to focus on core issues; ability to manage time smartly; manages resources soundly.
CRITICAL THINKING - is the ability to be thoughtful and draw pertinent conclusions after a discussion or meeting; can eventually support the final outcomes and decisions.
FOSTERING COLLABORATION/TEAMWORK - The ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
RESULTS ORIENTED - The ability to focus on the desired result of one's own department's work, setting challenging goals, focusing on the goals, and meeting or exceeding them.
THOROUGHNESS/DETAIL ORIENTED - Ensuring that one's own and others' work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.
Qualifications
Education
- Bachelor's degree in Life Sciences, Engineering or related field required.
- Advanced degree (MS, PhD, MBA) preferred.
Experience
- 15+ years in biopharmaceutical or vaccine manufacturing.
- 7+ years in leadership roles with operational accountability.
- Proven experience in sterile biologics manufacturing.
- Experience with regulatory inspections and quality standards.
- Demonstrated P&L management experience.
- Proven track record in vaccine, biologics, or sterile manufacturing operations.
What We Offer
- Health Insurance (medical, dental, vision)
- 401(k) plan for retirement savings
- Paid time off (vacation, sick leave, holidays)
- Life insurance
- Employee assistance program
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More Info at www.bimedacareers.com
