Supervisor, Manufacturing

仕事内容

The Manufacturing Supervisor oversees a team of technicians in a cGMP-regulated pharmaceutical environment, ensuring safe, compliant, and efficient production operations. The role includes managing daily workflows, training and evaluating staff, maintaining equipment and cleanroom standards, and coordinating with QA, QC, and Inventory Control to support production goals. The supervisor also leads process‑improvement initiatives using Six Sigma/Kaizen methods, reviews documentation for batch release, handles hazardous materials, and applies strong GMP knowledge to troubleshoot moderately complex issues with minimal supervision.

Role and Responsibilities:

• Manages a team or shift of personnel and serves as a mentor to junior staff.

• Has an ability to communicate clearly and effectively with peers within the organization.

• Leads special team projects within the manufacturing unit/function.

• Serves as a representative on cross-functional projects to support more senior colleagues in the function.

• Exercises diplomacy and critical thinking skills when troubleshooting issues with internal and external groups.

• Clearly and concisely explains process/product features, performance and deviations to multiple audiences.

• Manages the storage, replenishment, usage, and discarding of hazardous and volatile chemicals.

• Performs daily checks of the equipment and clean room areas and follows through with service requests to correct identified issues.

Essential Duties and Job Functions:

• Attends mandatory company training and ensures he/she is trained in production processes.

• Provides hands-on guidance to Manufacturing technicians.

• Conducts technicians’ performance evaluations, one on one meetings, and quarterly check ins.

• Expedites production scheduling through communication with QA/QC and Inventory Control personnel.

• Delegates and oversees corrective maintenance work orders for clean room equipment and rooms.

• Establishes and maintains 6S housekeeping standards for manufacturing owned areas.

• Maintains an accurate inventory of product components within L10 storage locations.

• Supervises personnel, including organizing and prioritizing daily tasks, performing/scheduling training, writing performance reviews.

• Works 9

• Uses advanced statistical techniques to complete projects.

• Uses more complex research techniques and methodologies like Six Sigma and Kaizen to improve process/product quality.

• Demonstrates proficiency in regulatory affairs and applies knowledge to processes.

• Writes and/or implements changes to controlled documents (e.g., SOP’s, Specifications, Methods, etc.) as needed.

• Exercises judgment within well-defined and established procedures and practices to determine appropriate action with minimal supervision.

• Develops solutions to moderately complex problems and conducts final reviews of logbooks and production records prior to batch release.

Knowledge, Experience and Skills:

• Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents (i.e. SUPAC, PACPAC).

• Is able to provide solutions to moderately complex to semi-routine problems

• Demonstrates excellent verbal, written, and interpersonal communication skills

• Demonstrates strong computer, organizational, and project management skills.

• Demonstrates ability to recognize deviation from accepted practice.

• Demonstrates ability to apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis.

• Demonstrates ability to successfully supervise and support junior staff.

Basic Qualifications:

• BA and 6+ years of relevant experience

• MS and 4+ years of relevant experience

• Prior experience in a cGMP related industry is required, within Biopharmaceutical or Pharmaceutical industry preferred.

• +2 years of prior people management preferred.

• Flexibility to work 12 hour shifts that cover 24/7 production schedules (including all major US Holidays)