Team Lead, Manufacturing Associate *PC 1509
Your Role:
This position is responsible for manufacturing biologics (LV) under cGMP conditions. Staff must follow established procedures, execute batch production records using good documentation practices and adhere to gowning procedures required for work in cleanroom environment.
Provides technical and operational leadership, assists Department head to ensure on time execution of operations.
Essential Duties and Responsibilities:
- Adhere to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, modes of operation.
- Execute manufacturing process by batch record instructions and perform GMP documentation review to ensure completeness and accuracy.
- Assist Manufacturing Supervisors in managing daily production activities.
- Works with MS&T, Manufacturing Supervisors and the Manufacturing team to provide technical, process and equipment knowledge in resolving issues and deviations.
- Assists Supervisors in scheduling and resource allocation for daily work, requests materials and consumables for manufacturing.
- Conduct Manufacturing training for new team members.
- Lead in authoring, reviewing and execution of Standard Operating Procedures (SOPs), Material Specifications (MSs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs), Change Controls, Deviation Investigations.
- Responsible for the cleaning of equipment, cleaning of work areas, maintenance and use of production equipment in strict accordance with cGMPs, SOPs and safety policies.
Requirements:
- High School Diploma; 4+ years of related experience.
- Previous GMP and aseptic technique experience is desired.
Skills:
- Ability to articulate with production equipment and / or manufacturing process problems.
- Able to provide detailed communication to multiple departments.
- Excellent computer skills
- Strong verbal and written communication skills.
- Must have a Quality and safety mindset and be a fast learner.
Physical Demands:
- Good eye/hand coordination
- Use keyboard/computer/phone
- Detect/Distinguish hearing
- Position self to move
- Calibrate precise measurements
- Move/Transport 15 kg
- Visual Acuity
- Detect/Distinguish smell
- Maintain stationary position
- Move/Traverse
- Reaching
- Ability to safely operate hand tools
- Repetitive movement activities
Work Environment:
- Regular and predictable attendance
- Work irregular hours that often include nights and weekends
- Work in multiple locations
- The role will most likely transition from 5 - 8 hour shifts to 4 - 10 hour shifts late in 2027.
The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, location, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate of possible compensation at the time of posting.
In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.Miltenyi Biotec, Inc is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity
Miltenyi Biotec, Inc. participates in E-Verify.The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.
Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry — our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.