Manager / TL Aseptic Manufacturing 1100am-730pm

Role Summary

Manager / Team Lead, Aseptic Manufacturing. Onsite role at the Rochester site, overseeing a team of manufacturing operators in the aseptic production of sterile injectable products. Responsible for leading production, ensuring regulatory compliance, driving continuous improvement, and delivering quality output on schedule. Core shift is 11:00am–7:30pm, Monday through Friday; role involves collaboration with quality, production, procurement, and other cross-functional teams to support patient needs.

Responsibilities

• Oversee a team of manufacturing operators engaged in aseptic production; provide leadership, planning, and accountability; manage production cost centers; supervise personnel to ensure high-quality output; uphold regulatory compliance and drive continuous improvement.
• Oversee aseptic prep, micronizing, gel compounding, formulation, and filling of sterile injectables at the Rochester site; collaborate with managers and technical staff; troubleshoot and resolve process/equipment issues; ensure compliance with pharmaceutical, pharmacological, biological, biochemical, medical, and microbiological principles.
• Accountable for achieving objectives and preparing resource forecasts; provide technical guidance and oversight; support problem-solving and professional development; implement counseling and corrective actions when necessary.
• Demonstrate comprehensive understanding of industry, functional, and Pfizer-specific principles; lead defined processes and production teams; apply foundational leadership practices.
• Develop solutions to complex issues using analysis, innovation, and practical judgement; adapt to changing priorities while adhering to HR policies and colleague relations guidelines.
• Support Pfizer’s mission to reach milestones and help patients worldwide.
• Manage staff in production ensuring compliance with regulatory requirements; coordinate cross-functional projects; devise solutions; work with quality, procurement, suppliers, and forwarding agents; liaise with senior personnel; support investigations and continuous improvement; maintain audit readiness and daily production activity schedules; mentor and develop team members; deliver products on time and within budget; design workflows; act as SME; promote aseptic best practices; assist with OJT documentation; complete SAP transactions; review batch records; oversee DOC operations; initiate maintenance orders; distribute SOPs; manage material order checklists; review logbooks for accuracy; maintain operator qualifications; conduct timecard reviews; supervise Manufacturing and Aseptic Technicians; prepare Manufacturing Event Reports.

Qualifications

• Required: Bachelor's degree with at least 4 years of experience; OR Master's degree with at least 2 years; OR PhD with 0+ years; OR Associate's degree with 8 years; OR a high school diploma (or equivalent) and 10 years of relevant experience.
• Required: Previous supervisory or related experience.
• Required: A strong personal motivation and aptitude for coaching, leading, and managing individuals and teams.
• Required: An aptitude for understanding process technology and equipment, aseptic processing, proven leadership ability, decision making ability, and excellent oral and written communication skills.
• Required: Demonstrated ability to interact effectively with all levels of the organization.
• Required: Candidate must possess flexibility to respond to constantly changing conditions and priorities.
• Preferred: Relevant pharmaceutical industry experience.
• Preferred: Previous leadership experience.
• Preferred: Experience in providing technical leadership while working remotely.
• Preferred: Strong project management skills.
• Preferred: Ability to navigate complex organizational structures.
• Preferred: Experience in fostering both behavioral and technical growth within an organization.
• Preferred: Strong collaboration skills.
• Preferred: Experience in setting objectives and forecasting resource needs.
• Preferred: Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity; interest in responsible AI practices, risk management, and ethical use.

Skills

• Leadership and people management
• Cross-functional collaboration and stakeholder management
• Regulatory compliance knowledge (cGMP, GDP)
• Aseptic processing and manufacturing operations
• Process design, optimization, and troubleshooting
• Analytical thinking and problem solving
• Project management and scheduling
• Documentation and training development (OJT, SOPs, SAP transactions)
• Quality systems and batch record review
• Effective communication across all organizational levels

Education

• Education aligned with qualifications above: Bachelor's degree with 4+ years of experience; or Master's with 2+; or PhD with 0+; or Associate's with 8; or high school diploma with 10 years of relevant experience.

Additional Requirements

• Physical/Mental: Spend majority of time on the shop floor and be trained in appropriate gowning.
• Schedule: Onsite position with core hours from 11:00am to 7:30pm (Monday through Friday); occasional weekend/alternative shifts may be required.
• Environment: This position is in a Penicillin facility; candidates must not be allergic to penicillin.
• Travel: Limited travel may be required.