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4 days old

Production Supervisor

Kelly Services
Carlsbad, CA 92008
**Production Supervisor**


**Location:** Carlsbad-CA

**Position Work Hours:** 12/hour Shift - 7AM to 7PM


At Microbial Manufacturing Services (MMS), a new Business Unit within Pharma Services Group, we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.


**How will you make an impact?**


This position requires routine hands-on bioprocess manufacturing within a cGMP cleanroom commensurate with the individuals level of technical expertise, training, and qualification strictly following defined procedures.


**What will you do?**


+ Perform cGMP manufacturing activities for Upstream and Downstream operations according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule

+ Meticulously maintain facility records, batch records, and process/system records as required throughout the manufacturing process according to GDP standards

+ Through strict adherence to manufacturing controls, ensure finished drug substance/drug product and all intermediates comply with applicable regulatory requirements (e.g. FDA, EMA), cGMPs, QA/QC and safety standards

+ Ability to learn biopharmaceutical manufacturing processes including but not limited to: the use of autoclave, buffer preparation, cleaning, stocking, disinfectant prep, decontamination, fumigation, waste management, equipment maintenance, materials movement, staging, etc.

+ Adheres to the production schedule ensuring on-time delivery and efficient production logistics

+ Ability to utilize Quality Systems (Deviations, CAPAs, Change Control, etc.)

+ Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities

+ Promote and facilitate a safe working environment for all employees.

+ Establish work center and individual performance goals and work with other department supervisors to develop and implement common key performance indicators (KPIs). Effectively review metrics to measure and drive team performance.

+ Build and develop team of direct reports, by hiring, providing coaching, training and professional development to employees

+ Work with other functional areas to provide cross training so that all department functions are adequately staffed to meet demand and ensure that business objectives are met, and productivity improvements are implemented.

+ Coordinate with department team members and the planning team to develop a manufacturing schedule and establish controls to ensure customer needs are met.

+ Identify and implement appropriate corrective and preventive actions identified by audits, failures, customer complaints and safety incidents.

+ Work with team to improve production methods managing process change control to maintain compliance with the site quality requirements.

+ Direct the preparation and revision of department owned documentation. Ensure that all relevant documentation and procedures are up-to-date and effective.

+ Identify productivity savings and execute site improvements utilizing PPI, 5S, Lean, and Kaizen methodologies


**Education**


+ Bachelors degree in Chemistry, Engineering or other related discipline required / or equivalent work experience


**Experience:**


+ Minimum 5 years of manufacturing experience in an ISO or QMS regulated environment with at least 3 years of supervisory experience, preferably in a CDMO environment

+ Demonstrated people and project leadership skills with a proven ability to achieve objectives by establishing a vision, determining strategies and directing resources

+ Strong organizational skills to efficiently manage multiple projects with changing priorities and due dates, and work within the department and extended operations team to meet commitments

+ Ability to represent the department with various levels of management and disseminate information between upper management and department staff

+ Experience using Operations, Manufacturing, Supply Chain, and Quality business systems with knowledge of operational transactions and data requirements

+ Excellent documentation and communication skills (oral and written)

+ Proficient in Microsoft Office


**Knowledge, Skills, Abilities**


+ Strong interpersonal and communications skills; written and oral

+ Solid understanding of applicable regulatory requirements

+ Strong working knowledge of Microsoft Office


\#P1


**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** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-23 Expires: 2022-10-24

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Production Supervisor

Kelly Services
Carlsbad, CA 92008

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