2nd Shift Manufacturing Supervisor – Filling and Packaging
Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling, and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.
Position and Scope
The purpose of this position is to assist with organization and execution of production flows as well as documentation of production results for our operations teams in a GMP level facility. This is a hands-on position, which will require supporting the team in day-to-day activities, ensuring training compliance, and batch records are completed on time and error-free. The individual will also support continuous improvements within the manufacturing team and support process qualifications. We are looking for an energetic, hands-on, knowledgeable problem solver who can assist with the implementation of new filling/finishing labs, SOPs, and laboratory equipment as necessary to complete client projects. Strong time management and organization skills along with interpersonal skills are needed for this exciting new opportunity to help create a highly efficient manufacturing team.
Position Requirements and Experience
The desired candidate will have:
- BS in Molecular Biology, Biochemistry, BBA in Supply Chain Management, and 2+ years of experience in an industrial environment (manufacturing or R&D) with focus on molecular biology or 4 – 5+ years of relevant experience
- Proven knowledge in process validation
- Knowledge of aseptic techniques
- Experience using scales/balances, mixers and stir plates
- Plating platforms, labeling equipment, and sealing equipment experience
- Good documentation practices
- Strong communication skills and the ability to work with and lead cross-functional teams under strict timelines
- Excellent problem solving / troubleshooting skills and the ability to analyze and interpret data to make business-critical decisions
- Ability to execute validation experiments
- Quality system compliance while working in a cGMP and ISO 13485 production environment
- Attention to detail and disciplined in execution
- Strong initiative and willingness to take ownership and drive projects to completion
- Interest, ability, and willingness to work in the production lab for extended periods of time
- Be a mentor and train manufacturing team members, providing technical guidance and leadership as necessary
- Ability to work independently and also in a team-based environment effectively
- Ability to create and revise manufacturing documentation, processing documents, SOPs, manufacturing pilot plans, etc.
- Capable of serving as a subject matter expert for manufacturing during varied audits by customers and regulatory bodies
- Advise the manager of factors that may affect the quality of the product, initiate problem reports for deviations and non-conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA)
- Ability to supervise a team of 20 to 30 direct reports and interview candidates as the team grows
- Organized, responsible, dependable with an ability to work in a team environment
- Knowledge in lab space layout and design from a Lean Manufacturing perspective
- Experience following standard operating procedures and recording data extemporaneously in batch documentation while following good documentation practices
- Experienced in the use of Master Controls and LIMS for manufacturing applications
- Experience with product transfers or new product implementations
- ERP implementation and operational experience with Net Suites
- Working knowledge of 5S and Lean Manufacturing Principles
- Hands-on experience in molecular biology (2 years) with proven skills of high-throughput filling processes handling DNA, RNA, sequencing, microarray products
Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
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