Biologics Manufacturing Team Lead

Lentigen-Technology-Inc.; Gaithersburg (MD); Sur place; USD 73 000 - 86 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) plan

Bonuses/commissions

Résumé du poste

Miltenyi Biotec, Inc. in Gaithersburg, MD is seeking a manufacturing professional to produce biologics under cGMP. The role requires following SOPs, completing batch records, and maintaining cleanroom procedures.

You will mentor staff, support supervisors, and help drive on-time production with strong documentation. Applicants should have a High School Diploma and 4+ years in GMP/aseptic settings, with excellent communication and computer skills.

Qualifications

• Ability to articulate with production equipment and manufacturing processes.
• Excellent written and verbal communication across departments.
• Proficient computer skills for documentation and data entry.
• Knowledge of cleanroom SOPs and gowning procedures.

Responsabilités

• Adhere to clean room SOPs for gowning and workflows.
• Execute manufacturing processes per batch records and ensure GMP documentation.
• Assist Supervisors in planning and resource allocation for daily work.
• Collaborate with MS&T and manufacturing teams to resolve issues and deviations.
• Lead in authoring and maintaining SOPs, MSs, SMPs, BPRs, change controls and deviations.
• Ensure equipment cleaning, area cleanliness, and safety compliance.

Connaissances

Troubleshooting

Communication

Computer skills

Cleanroom SOPs

Formation

High School Diploma

Description du poste

Miltenyi Biotec, Inc. in Gaithersburg, MD is seeking a manufacturing professional to produce biologics under cGMP. The role requires following SOPs, completing batch records, and maintaining cleanroom procedures.

You will mentor staff, support supervisors, and help drive on-time production with strong documentation. Applicants should have a High School Diploma and 4+ years in GMP/aseptic settings, with excellent communication and computer skills.