Manager Internal Fill/Finish MFG

Role Summary

Manager Internal Fill/Finish Manufacturing (MFG) position responsible for managing all facets of internal clinical and commercial scale fill/finish, inspection, assembly and packaging activities, with leadership over manufacturing team, policy development, and capital planning.

Responsibilities

• Participates in equipment and technology design, installation and qualification; acts as fill/finish SME, coordinating with cross-functional teams.
• Drives innovation in sterile/aseptic processing and implements advancements to meet business needs.
• Guides and oversees validation and technical transfer activities for fill/finish equipment and processes.
• Interfaces with Facilities, Process Development, Process Analytical Sciences, Combination Products, Regulatory, QA, and QC.
• Builds capability and teams; oversees training of operations and maintains organizational metrics.
• Provides leadership and management to the manufacturing team; develops policies, schedules, procedures, and programs.
• Recommends capital expenditures and supports capital project realization.
• Represents manufacturing during regulatory and client audits.
• Develops department goals and objectives; collaborates with staff to manage individual goals.
• Performs personnel management tasks including vacation scheduling, development, and performance evaluations.
• Tracks and trends technical and business process metrics to ensure efficient operations.
• Reviews and approves SOPs, specifications, regulatory filings, or other controlled documents as needed.
• Participates in long-term process, staff, and budget planning.

Qualifications

• Required: BS/BA in engineering, materials science, physical or biological sciences and 6 years of cGMP manufacturing experience, including prior supervisory experience, or equivalent.
• Preferred: Experience in regulatory inspections as SME; technology transfer and equipment/process validation in aseptic parenteral fill/finish; change control and compliance investigations; technical support; operation/qualification of highly automated equipment; creation of batch records and SOPs.

Skills

• Knowledge of cGMP manufacturing environment; familiarity with formulation, aseptic filling, visual inspection, assembly, labeling, and packaging of liquid and lyophilized injectables.
• Strong interpersonal, cross-cultural, communication, negotiation, and problem-solving skills.
• High emotional intelligence; ingenuity, creativity, and resourcefulness.
• Ability to interpret instructions and work toward goals individually or as part of a team.
• Ability to understand team and stakeholder needs and foster a positive environment.
• Experience with regulatory inspections as SME (preferred).

Education

• BS/BA in engineering, materials science, physical or biological sciences

Additional Requirements

• Level determined by relevant education and experience.
• Travel or physical demands not specified as essential; none listed.