**Manufacturing Manager, Fill / Finish**
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The Manufacturing Manager is responsible for the production of
clinical biopharmaceuticals in a multi-product environment. The
position is responsible for supervising and overseeing all drug
product aseptic filling and finish manufacturing activities,
including final formulation and filtration, component preparation,
filling/capping, labeling and inspection operations. The position
requires significant on-the-floor activities, and subject matter
expertise in aseptic filling operations. Additional job
responsibilities include generation, execution and review of
manufacturing and technical documentation, equipment and
trouble-shooting, staff training, compliance, and scheduling.
The manager may also participate in validation activities,
continuous improvement activities, investigations and
trouble-shooting activities, support regulatory and site
inspections, and provide input for capital and expense budgets.
The Manager is accountable for managing the activities of
manufacturing staff, monitoring the maintenance of production
equipment and facilities in the manufacturing area, overseeing
complete documentation of all required production activities and
ensuring compliance with current Good Manufacturing Practices
(cGMP), Standard Operating Procedures (SOPs), product licenses,
corporate policies and safety practices.
Supervisory and Management:
- Manage the upstream manufacturing work unit to meet production
requirements and schedules. Monitor inventories and departmental
- Staff positions as required, including interviewing and
candidate selection. Ensure optimal staffing and scheduling of
- Supervise the training of upstream manufacturing staff. Ensure
that departmental cGMP and safety training is performed and
- Author, review and/or approve departmental documentation and
procedures, including batch records, SOPs, validation protocols,
- Assure that production equipment and facilities are maintained
in proper working condition and cGMP compliance.
- Lead and roll out Operational Excellence programs targeting
department efficiency, production improvements, cost reductions,
and deviation reductions.
- Provide leadership and career development to the manufacturing
staff. Author and review staff performance evaluations and
- Provide a safe and compliant work environment. Ensure that
routine safety and in-house compliance audits are conducted.
- Handle employees' complaints and disciplining when
- Schedule all upstream manufacturing operations and regularly
communicate the schedule within the manufacturing department and to
other groups as necessary.
Technical Leadership and Documentation:
- Act as subject matter expert for fill / finish manufacturing
- Troubleshoot equipment and process failures.
- Provide technical expertise to resolve manufacturing
- Lead process control and optimization programs.
- Lead process/technology transfer projects, and the final
stages of process development.
- Supervise and perform, as needed, the creation and revision of
production documents in order to maintain GMP compliance and
efficiency. Ensure that all SOPs and batch records are maintained
to reflect current manufacturing methods and are in conformance
with product licenses.
- Ensure timely submission and completion of all manufacturing
investigation reports and documentation of deviations to minimize
- Ensure that all compliance commitments are completed on time
and provide documented evidence to support closure of each item
according to the established timeline.
- Generate, review and/or approve all manufacturing operations
related documentation, including process validation protocols and
variance reports, and the respective follow-up (Document Change
Request forms, Engineering and Facility
Change Control Request forms, Purchase orders, and
Instrumentation Deviation Reports).
EXPERIENCE / QUALIFICATIONS:
- 3 years direct supervisory experience in a GMP environment
- 5 years direct experience in aseptic filling
- Cell culture experience (Preferred)
- Bachelor's (Preferred)
**_For immediate consideration apply today!_**
**_Questions? Please reach out to Dustin at
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