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Manufacturing Team Lead
1 month ago
We are seeking a highly skilled and experienced Manufacturing Team Lead to join our team in San Diego, CA.
Job Summary:The Manufacturing Team Lead will be responsible for leading manufacturing run activities, including pre-production and post-production tasks, to support the full process. This role will also provide leadership and guidance to other manufacturing associates assigned to the applicable run.
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.
- Coach and mentor whenever necessary, fostering a positive, result-driven teamwork environment.
- Thorough knowledge of cGMPs, including equipment, technology, and quality systems requirements.
- Computer skills, including 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.
- Experience supporting and/or leading deviation investigations.
- Excellent communication, organizational, writing, and problem-solving skills.
- Ability to work independently and make critical decisions.
- Establish proper priorities and manage time and available resources.
- 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 and Lean manufacturing knowledge a plus.
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.
Occupational Demands:- Ability to lift and/or push 35 lbs.
Grifols offers a competitive salary range of $38.88 to $58.31 per hour, plus up to 5% of the company bonus pool. We also offer a wide variety of benefits, including medical, dental, vision, PTO, up to 5% 401(K) match, and tuition reimbursement. Final compensation packages will 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.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, non-expired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department.
Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter.
All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic or status protected by law.
