Team Lead, Manufacturing Associate *PC

• Posted on October 21, 2026

• Gaithersburg, MD 20878, USA
• On-site
• Manufacturing
• Full-Time
• Requisition #: TEAML
  003673

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.

• 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.

• High School Diploma; 4+ years of related experience.
• Previous GMP and aseptic technique experience is desired.

• 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.

• 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

• 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 hiring range for this position is expected to fall between $73,283 - $86,224 /year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

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…