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25 days old

Manufacturing Manager (Fill/Finish) - Richmond, CA

Kelly Services
Richmond, CA 94802
**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 process

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.


JOB FUNCTIONS:


Supervisory and Management:


- Manage the upstream manufacturing work unit to meet production requirements and schedules. Monitor inventories and departmental budget.

- Staff positions as required, including interviewing and candidate selection. Ensure optimal staffing and scheduling of personnel.

- Supervise the training of upstream manufacturing staff. Ensure that departmental cGMP and safety training is performed and documented.

- Author, review and/or approve departmental documentation and procedures, including batch records, SOPs, validation protocols, etc.

- 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 promotion recommendations.

- Provide a safe and compliant work environment. Ensure that routine safety and in-house compliance audits are conducted.

- Handle employees complaints and disciplining when necessary.

- 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 operations.

- Troubleshoot equipment and process failures.

- Provide technical expertise to resolve manufacturing issues.

- 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 production delays.

- 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:


Experience:

- 3 years direct supervisory experience in a GMP environment (Required)

- 5 years direct experience in aseptic filling

- Cell culture experience (Preferred)


Education:

- Bachelor's (Preferred)


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Dustin at DUSG877@kellyservices.com_**


**_\#TJP2021_SPEC_**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-03-29 Expires: 2021-04-29

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Manufacturing Manager (Fill/Finish) - Richmond, CA

Kelly Services
Richmond, CA 94802

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