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9 days old

Fill/Finish Manufacturing Supervisor

Kelly Services
Culver City, CA 90231
**Title: Fill/Finish Manufacturing Supervisor**


**Location: El Segundo, CA**


**Job Type: Direct-Hire, Full-Time (M-F 7am-4pm), On-Site**


**Job Description:**

The Fill/Finish Manufacturing Supervisor will play a critical role as the primary point of contact for manufacturing, maintenance, filling and finishing drug product. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and leading with minimal supervision. As a team member of the filling and finishing group you will work to support all activities to ensure the filling and finishing production schedules are met.


The manufacturing skills and training include expertise in biological filling and finishing including aseptic processing, sterile buffer and drug product preparation and clean room maintenance.


**Responsibilities:**

Supervise operations of manufacturing facility in a cGMP environment.

Execute production and resource schedule against operational plan.

Ensure performance of all process steps specific to manufacturing (e.g. filling, packaging, shipping, support).

Facilitate/lead technology transfers from Process Development and participate in CMO interface as required.

Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management.


Generate SOPs, MBRs, and EOPs for equipment and procedures used in routine biologics manufacture.

Complete the final review of completed manufacturing documentation per compliance standards and established timelines.


Provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews.


Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements.


Collaborate within department, cross-functionally, with leaders and outside vendors to meet objectives.

Take corrective action to bring about required changes using CAPA and change control procedures.

Other duties as assigned


**Requirements:**

BS or MS in chemical engineering, genetics, molecular biology, biotechnology, microbiology, biochemistry, or a related field.


Five (5) + years of relevant industry experience or MS with relevant research experience.


**Knowledge / Skills / Abilities:**

Proven track record of running a cGMP facility.

Extensive experience running cGMP manufacturing filling and finishing operations including setup, sterilization, aseptic filling, sampling.


A proven track record of accomplishments and timely delivery on goals.

Knowledge of aseptic filling and subsequent finishing of drug product.

Complex Problem Solving Ability: Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.


Critical Thinking: Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.


Judgment and Decision Making: Considering the relative costs and benefits of potential actions to choose the most appropriate one.


Speaking: Presenting to others to convey information professionally, efficiently and effectively.

Deductive Reasoning: The ability to apply general rules to specific problems to produce answers that make sense.

Demonstrated ability in cGMP bioprocess operations, particularly filling and finishing.

Knowledge of cGMP guidelines and good documentation processes.

Available to work a flexible schedule, including occasionally coming in nights and weekends to support sampling of critical processes.


**_For immediate consideration apply today!_**


**_Questions? Please reach out to Jessica at jessica.rubano@kellyscientific.com_**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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: 2022-05-09 Expires: 2022-06-09

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Fill/Finish Manufacturing Supervisor

Kelly Services
Culver City, CA 90231

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