Biologics Manufacturing Team Lead

Lentigen-Technology-Inc.; Gaithersburg (MD); On-site; USD 73,000 - 86,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

401(k) plan

Bonuses or commissions

Job summary

Miltenyi Biotec, Inc. in Gaithersburg, MD is seeking a manufacturing specialist to produce biologics under cGMP conditions. The role requires adhering to SOPs, gowning, and accurate documentation in a cleanroom environment.

You will lead with operations, support supervisors, and collaborate with MS&T to resolve deviations, while training new staff and helping schedule daily work.

The position offers a competitive salary and benefits package with health, vision, dental insurance and a 401(k).

Qualifications

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

Responsibilities

• Adhere to clean room SOPs for gowning, traffic flows, modes of operation.
• Execute manufacturing process by batch record instructions and perform GMP documentation review.
• 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 SOPs, MSs, SMPs, 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.

Skills

GMP knowledge

Aseptic technique

Gowning procedures

SOPs

Documentation review

Computer skills

Communication skills

Quality mindset

Education

High School Diploma

Job description

Miltenyi Biotec, Inc. in Gaithersburg, MD is seeking a manufacturing specialist to produce biologics under cGMP conditions. The role requires adhering to SOPs, gowning, and accurate documentation in a cleanroom environment.

You will lead with operations, support supervisors, and collaborate with MS&T to resolve deviations, while training new staff and helping schedule daily work.

The position offers a competitive salary and benefits package with health, vision, dental insurance and a 401(k).