Team Lead, Manufacturing Associate PC 1459

Miltenyi Biomedicine•Gaithersburg, MD

3d•$73,283 - $86,224

About The Position

This position is responsible for manufacturing biologics (LV) under cGMP conditions. Staff follow established procedures, execute batch production records using good documentation practices, and adhere to gowning procedures required for cleanroom work. The role provides technical and operational leadership and assists the Department Head in ensuring timely execution of operations. The position supports daily manufacturing activities, troubleshooting, scheduling, resource allocation, materials requests, and training. It also leads the authoring, review, and execution of manufacturing documentation and change or deviation records. The employee is responsible for cleaning equipment and work areas and maintaining and using production equipment in accordance with cGMPs, SOPs, and safety policies. The role requires regular and predictable attendance, work at multiple locations, and irregular hours that often include nights and weekends. Shifts are expected to transition from five 8-hour shifts to four 10-hour shifts late in 2027. The hiring range is $73,283–$86,224 per year. The company offers health, vision, and dental insurance and a 401(k) plan, subject to eligibility requirements; certain positions may also be eligible for bonuses or commissions.

Requirements

High school diploma.
At least 4 years of related experience.
Ability to articulate production equipment and/or manufacturing process problems.
Ability to provide detailed communication to multiple departments.
Excellent computer skills.
Strong verbal and written communication skills.
Quality- and safety-minded, with the ability to learn quickly.

Nice To Haves

Previous GMP experience.
Previous aseptic technique experience.

Responsibilities

Follow cleanroom SOPs for gowning, traffic flows, and modes of operation.
Execute manufacturing processes according to batch record instructions and review GMP documentation for completeness and accuracy.
Assist Manufacturing Supervisors in managing daily production activities.
Work with MS&T, Manufacturing Supervisors, and the Manufacturing team to provide technical, process, and equipment knowledge to resolve issues and deviations.
Assist Supervisors with scheduling and resource allocation for daily work, and request manufacturing materials and consumables.
Conduct manufacturing training for new team members.
Lead the authoring, reviewing, and execution of SOPs, Material Specifications (MSs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs), Change Controls, and Deviation Investigations.
Clean equipment and work areas, and maintain and use production equipment in accordance with cGMPs, SOPs, and safety policies.