Team Lead Manufacturing - Variable Shift
GRIFOLS, S.A.
Summary
Grifols Diagnostics Solutions Inc is seeking a Team Lead, Manufacturing in San Diego, CA. The Team Lead role will lead the Immunohematology manufacturing activities including all applicable pre-production and post-production tasks required to support the full process. This position will also provide leadership and guidance to other manufacturing associates assigned to the applicable run. The Team Lead, Manufacturing will focus on fill/finish manufacturing and leading a team of Reagent Bulk, Fill and Packaging Technicians.
Job description
Responsibilities
- Guide and lead the work of department associates executing daily operations.
- Act as a point of contact for the production of an assigned run from start to finish.
- Assign production support activities to other associates in accordance with the schedule.
- Ensure that all production operations are conducted in full compliance with Grifols policies, regulatory (GMP, FDA, ISO) and safety requirements.
- Coordinate pre-production checks and activities as required.
- Troubleshoot and resolve applicable technical issues encountered in the process.
- Coordinate and execute applicable analytical testing activities.
- Assist with batch record review and corrections as required.
- Review, initiate, and approve change requests for the department.
- Initiate production related deviations in the associated quality system.
- Manage assigned investigations as required including the implementation of corrective actions.
- Own and manage assigned corrective/preventative (CAPA) actions in the associated quality system.
- Coaching and mentoring whenever necessary, foster positive, result-driven teamwork environment.
- Can perform supervisory activities as needed or as assigned.
Knowledge, Skills, and Abilities
- Must have a thorough knowledge of cGMPs including equipment, technology, and quality systems requirements.
- Computer skills are required (Word, Excel, Outlook). SAP knowledge a plus.
- Strong technical knowledge in commercial Immunohematology techniques.
- Strong troubleshooting abilities including process monitoring to identify opportunities for continuous improvement.
- Strong interpersonal and cross functional team building skills.
- Must have experience supporting and/or leading deviation investigations.
- Excellent communication skills, organizational skills, writing and problem solving skills required.
- Must be able to work independently and make critical decisions.
- Must establish proper priorities and manage time and available resources.
- Must be able to establish and maintain effective working relationships with customers and co-workers.
- Understand the operation of all equipment associated with the process being supervised.
- Understand GMP, FDA and ISO regulatory requirements.
- 5S, Lean manufacturing knowledge a plus.
- Strong organization and time management skills, with the ability to prioritize and get activities completed on-time.
Education and Experience
Minimum requirements: BS/BA in one of the biological or physical sciences. Minimum of 6 years' experience in the biotechnology / medical devices industry and a minimum of 5 years working in a regulated environment. Minimum 2 years of leadership experience in a regulated immunohematology or similar biological-based manufacturing environment.
Occupational Demands
Ability to lift and or push 35 lbs.
Requirements
- BS/BA in one of the biological or physical sciences
- Minimum of 6 years' experience in the biotechnology / medical devices industry
- Minimum of 5 years working in a regulated environment
- Minimum 2 years of leadership experience in a regulated immunohematology or similar biological-based manufacturing environment
- Thorough knowledge of cGMPs including equipment, technology, and quality systems requirements
- Computer skills (Word, Excel, Outlook)
- Strong technical knowledge in commercial Immunohematology techniques
- Strong troubleshooting abilities including process monitoring
- Strong interpersonal and cross functional team building skills
- Experience supporting and/or leading deviation investigations
- Excellent communication, organizational, writing and problem solving skills
- Ability to work independently and make critical decisions
- Understand GMP, FDA and ISO regulatory requirements
- Ability to lift and or push 35 lbs
Benefits
- Medical, Dental & Vision
- Life Insurance
- PTO
- Paid Holidays
- 401(k) Matching
- Tuition Reimbursement
- Company Bonus Pool
Company overview
Grifols, S.A. is a global healthcare company and leading producer of plasma-derived medicines, founded in Barcelona, Spain in 1909. As the European leader and third largest plasma-derived medicine manufacturer worldwide, Grifols specializes in developing, producing, and marketing essential plasma-derived protein therapies for patients suffering from rare, chronic, and life-threatening conditions. The company operates across four main business units: Biopharma (plasma-derived medicines), Diagnostic (transfusion medicine and clinical diagnostics), Bio Supplies (biological materials for research), and Healthcare Solutions for Hospitals. With over 23,800 employees serving more than 110 countries, Grifols maintains 15 industrial facilities across seven countries and operates approximately 400 plasma donation centers globally. The company focuses on therapeutic areas including immunology, infectious diseases, pulmonology, hematology, hepatology, intensive care, and neurology, with more than 1,200 researchers working across 12 R&D centers worldwide. Grifols is publicly traded on both the Madrid Stock Exchange (GRF) and NASDAQ (GRFS), generating approximately €7.2 billion in annual revenue.