Lead, Manufacturing (Front End Nights)

Leadership

Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight.
Promotes collaboration and alignment among peers.
Provides direction and hands-on training for staff.
Supports the management of staff with supervisor.
Lives department values and sets the standards for others to operate.
Fosters an environment of compliance, strong work ethic and ongoing learning.

Contribution

Takes responsibility for moderate level projects.
Effective interaction with peer Leads across manufacturing to create alignment and improvement.
Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities.

Process Knowledge

Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance.
Able to troubleshoot, identify issues and support resolutions with technical groups.
Uses scientific thinking and decision making in daily work.
Required to perform ongoing operational tasks in respective work area.

Technical Competency

• Proven experience with relevant process, theory and equipment.
  Experience with process automation and associated process equipment.
  Assists with review and approval of documentation including Batch Records and logbooks.
  Supports the closure of Manufacturing owned Quality Records (deviations, change requests).

Technical Documentation

• Provide feedback and/or suggested changes to operational procedures.
  Assist in the incorporation of new technologies, practices and standards into procedures.
  Capable of writing and reviewing process documents.

Quality and Compliance

• Complete understanding and adherence to cGMP’s as related to commercial operations.
  Support the closure of manufacturing discrepancies and change requests.
  Experience with business systems (PI ProcessBook, LIMS, Veeva, SAP, MES, etc.).