Grifols Diagnostics Solutions Inc is seeking a Team Lead, Manufacturing in San Diego, CA. The Team Lead role will lead manufacturing run 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 Fill Technicians.

We are seeking individuals with expertise in fill/finish manufacturing, team leadership, with at least a Bachelors in biological or physical sciences and at least 6 years of experience in the biotechnology/medical device industry. At least 5 years of experience supporting a GMP environment.

Shift Requirement: Variable shifts

Responsibilities:

• Guide and lead the work of department associates executing daily operations.
• Act as a point of contact for the production of an assigned antigen 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, ATLAS, and TrackWise based system knowledge a plus.
• Strong technical knowledge in commercial Purification and separation 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.
• Established troubleshooting abilities including process monitoring
• Must have a thorough knowledge of cGMPs including equipment, technology, and quality systems requirements

Education:

Minimum requirements: BS/BA in one of the biological or physical sciences

Experience:

Minimum of 6 years’ experience in the biotechnology / medical devices industry and a minimum of 5 years working in a regulated environment.

Occupational Demands:

• Ability to lift and or push 35 lbs.

Pay Scale

The estimated pay scale for this Team Lead, Manufacturing role based in San Diego, California is $40.69 to $50.87 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Pay: $40.69 - $50.87 per hour

Work Location: In person