Summary:
The Manufacturing Supervisor II is responsible for a Manufacturing department’s day to day operations to ensure the manufacture of products are within cGMP, safety regulations and policies and procedures. The Manufacturing Supervisor II will be reporting to the Manufacturing manager and this is an onsite position located in San Diego, CA. At this level, assignments and problem-solving techniques are at a moderate/high complexity. Serves as an SME within field of assigned Manufacturing area - Immunohematology.
In order to qualify for the Manufacturing Supervisor II, individuals must have a Bachelor's degree with at least 3 years of supervisory experience, or a Master's degree with at least 1 year of supervisory experience. Additionally, candidates must have experience in immunohematology or a similarly biological-based production environment, with direct experience managing immunohematology processes being highly preferred.
Shift: Variable - must be open to variable shifts
Primary Responsibilities:
- Performs the duties defined in the Manufacturing Supervisor level position.
- Leads process/product troubleshooting in order to correct/maintain desirable process parameter.
- Acts as an initial point of contact for partner groups (i.e. Maintenance, Quality, Tech Doc Support, etc.). Research and address process deviations, documentation errors, etc.
- Manage balance between technical and management issues using multiple skill sets (analyzing, evaluating, creating, reasoning and reaching conclusion) and meet changing priorities.
- Develops alternative solutions to problems, handles moderate problems independently.
- SME within field of assigned Manufacturing area - Immunohematology.
- Immunohematology manufacturing responsibilities and sufficient technical knowledge to ensure business continuity for Blood Typing Solutions San Diego (processes, product lines, controlled environments)
- Availability to support and interface with all three shifts to maintain full operational coverage and alignment
- Knowledge of diagnostics manufacturing processes, including regulated environments (FDA/ISO 13485), quality systems, and reagent/materials workflows
- Experience with production machinery and Gel Cards/RRBC performance metrics (KPIs), including equipment operation, troubleshooting, and throughput optimization
- Strong organizational, planning, and workflow‑management capabilities to coordinate resources, SAP transactions, materials, documentation, and shift execution
Knowledge Skills and Abilities:
- Ability to communicate effectively at all levels of the organization.
- Ability to lead teams and promote a positive and thriving team environment.
- Ability to troubleshoot and provide sound solutions for process related matters.
- Working knowledge of Immunohematology processes and demonstrated independent decision making ability
- Demonstrated experience at a supervisor level managing timelines and processes, establishing priorities, setting goals for team, driving accountability and meeting deliverables.
Education and Experience:
- BA/BS degree plus 3 years of supervisory experience
- Master’s degree plus 1 year of supervisory experience
- Prior direct experience managing immunohematology processes is highly preferred.
- Prior experience with Immunohematology or similar biological-based production is required.
Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Occupational Demands:
Physical Requirements - Able to lift and push up to 50 lbs.