Production Laboratory Manager
More Diagnostics is a well-established in vitro diagnostics (IVD) supply company based in Los Osos, CA. We have achieved an international reputation for developing reliable products that allow our clinical laboratory customers to obtain highly accurate test results.
The Production Laboratory Manager is essential to the ongoing success of More Diagnostics. This position will be responsible for sustaining our high-quality production process and advancing our analytical laboratory operations.
If you desire the opportunity to join a flexible and nimble business, based in the beautiful San Luis Obispo area, then keep reading. The ideal candidate will have a strong science background with a record of accomplishment in a laboratory production environment. Proven experience of success working in a small company culture is a must.
Oversight for the production process for the company
- Schedule production operations with input from Operations and Sales
- Manufacture a variety of clinical controls to meet product specifications
- Develop and follow production schedules to assure on-time delivery of finished product
- Maintain schedule for product testing at appropriate intervals from time of manufacture through product expiration
- Write and verify production and analytical SOP’S
- Ensure that all production records are complete and on time
Management of the analytical laboratory operations
- Understands quality requirements related to MDI product production
- Supervise production and laboratory personnel
- Performs or delegates assays to assure that products meet existing requirements for purity, activity, and functionality
- Specify, authorize, and purchase production or analytical lab equipment and supplies
- In coordination with QA Unit, responsible for investigation and correction of NCR’s and CAPA’s where Production is assigned as responsible dept
- Perform Research & Development projects, when requested
- Provide technical support to customers when directed
- Collaborate with industry partners
- Understands and complies with ethical, legal, and regulatory requirements applicable to MDI
- Problem solver, creative thinker, organized, and sound multi-tasking skills
- Proven ability to work as part of a team
- Solid written and verbal communication abilities
- Ability to interpret and communicate scientific results
- Self-starter and accountable to setting goals, implementing project plans, and monitoring progress
- Ability to quickly examine details and commit them to memory
- This role is accountable for all facets of production, testing and monitoring to ensure our high quality is consistently maintained. Self-auditing is essential.
- Learning equally from mistakes and successes. Being able to correct and accept responsibility when something deviates from SOP, and not taking “corrective actions” personally. Necessary for honest and compliant work in an IVD lab.
- Ability to simplify science to business colleagues and act as technical service liaison for customer inquiries/complaints.
- Bachelor’s Degree in biochemistry, chemistry, biology, or related field
- Minimum 3-years’ experience working in a laboratory production environment
- Proficiency with computers and Microsoft Office Suite
- Ability to excel in an entrepreneurial environment while understanding the importance of closely following regulatory and quality procedures
- Working knowledge or experience with ISO 13485:2016 standards and FDA regulations
- Prior medical device industry experience