Team Lead, Manufacturing Associate PC 1509

Miltenyi Biotec•Gaithersburg, MD

About The Position

This position manufactures biologics (LV) under cGMP conditions. The team lead follows established procedures, executes batch production records using good documentation practices, and adheres to cleanroom gowning requirements. The role provides technical and operational leadership and assists the Department Head in ensuring timely execution of operations. The role supports daily production, technical issue resolution, scheduling and resource allocation, materials requests, and training of new team members. It also leads the authoring, review, and execution of controlled manufacturing documents and records. The position is responsible for cleaning equipment and work areas and maintaining and using production equipment in accordance with cGMPs, SOPs, and safety policies. Miltenyi Bioindustry is a contract development and manufacturing organization providing development and manufacturing services for lentiviral vectors and cell and gene therapy products.

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 mindset.
Ability to learn quickly.
Good eye/hand coordination.
Ability to use a keyboard, computer, and phone; detect or distinguish hearing and smell; maintain visual acuity; position oneself, move or traverse, reach, and maintain a stationary position; calibrate precise measurements; transport 15 kg; safely operate hand tools; and perform repetitive movements.
Regular and predictable attendance.
Ability to work irregular hours, often including nights and weekends, and in multiple locations.

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 apply technical, process, and equipment knowledge to resolve issues and deviations.
Assist Supervisors with scheduling and resource allocation for daily work.
Request materials and consumables for manufacturing.
Conduct manufacturing training for new team members.
Lead 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.