Manufacturing Team Lead

Job Description

Manufacturing Team Lead

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 while 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 a daily thorough check of the equipment and clean room areas and follows through with service requests to for maintenance/automation/facilities teams to correct identified issues.

Essential Duties and Job Functions:

· Attends mandatory company training and ensures he/she is trained on 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 on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.

· 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) daily.

· Demonstrates ability to successfully supervise and support junior staff.

Basic Qualifications:

· At least 6 years of relevant experience and a BS or BA.

· At least 4 years of relevant experience and a MS.

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

· At least 2 years of prior people management preferred.

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