Biologics Manufacturing Team Lead (GMP)

Miltenyi Biotec; 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 is seeking a professional to manufacture biologics in a cGMP environment at Gaithersburg, MD. You will follow established procedures, execute batch production records, and maintain strict documentation and gowning practices for cleanrooms.

You will provide technical leadership, assist department heads, and help ensure on-time execution of operations while coordinating with MS&T and supervisory teams to address issues and deviations.

Qualifications

• Adhere to clean room SOPs, gowning, and traffic flows.
• Execute manufacturing process by batch records with GMP documentation.
• Assist supervisors with daily production activities.
• Lead in drafting and executing SOPs, MSs, SMPs, BPRs, Change Controls, deviations.
• Maintain equipment cleaning and safe operation per cGMPs.

Responsibilities

• Follow SOPs for gowning and cleanroom procedures.
• Complete batch records and GMP documentation review.
• Support daily production scheduling and resource allocation.
• Collaborate with MS&T and supervisors to resolve deviations.
• Train new team members in manufacturing processes.
• Author and review SOPs, MSs, SMPs, BPRs, Change Controls, deviations.
• Ensure equipment cleaning and safe operation.

Skills

GMP knowledge

Aseptic technique

Documentation

Cleanroom

Communication

Education

High School Diploma

Job description

Miltenyi Biotec is seeking a professional to manufacture biologics in a cGMP environment at Gaithersburg, MD. You will follow established procedures, execute batch production records, and maintain strict documentation and gowning practices for cleanrooms.

You will provide technical leadership, assist department heads, and help ensure on-time execution of operations while coordinating with MS&T and supervisory teams to address issues and deviations.