Senior Microbiology Scientist - Biopharma Process Ops (Hybrid)

Automatic Data Processing, Inc.; Branchburg Township (NJ); Hybride; USD 87 000 - 150 000; Plein temps

Avantages offerts par ce poste

Paid time off

Medical, dental, and vision insurance

Life insurance

Company-matched retirement savings

Wellness programs

Short- and long-term disability

Résumé du poste

Celltrion Branchburg, LLC is seeking a Process Microbiology Specialist to support biotechnology manufacturing in a cGMP environment. You will oversee a robust product protection program against adventitious agents and collaborate with Operations, QC Microbiology, Engineering, and other TS/MS scientists to guide testing strategies and investigations.

Responsibilities include monitoring in-process microbiological data, generating and maintaining documentation, leading deviation investigations, and

Qualifications

• Knowledge of aseptic manufacturing operations.
• Strong investigational skill and microbiology assay development/validation.
• Data-driven decision making and problem-solving capabilities.
• Strong interpersonal skills in a cross-functional teamwork environment.
• Excellent written and oral communication; technical writing including investigations.
• Ability to participate in and facilitate decision-making.

Responsabilités

• Monitor in-process microbiological data and present analyses at team meetings.
• Provide on-the-floor microbiological support and maintain manufacturing documentation.
• Lead deviation investigations; troubleshoot contamination incidents.
• Collaborate to implement equipment, procedure, and automation improvements.
• Provide microbiology guidance on facility/process-related controls and changes.
• Oversee contamination prevention and control per Product Protection.
• Develop in-process microbiological acceptance criteria and sampling requirements.

Connaissances

Aseptic operations

Investigational skills

Data-driven decision making

Interpersonal skills

Effective communication

Facilitate decision-making

Formation

BS in Microbiology or related sciences

Banded placement based on experience

Description du poste

Celltrion Branchburg, LLC is seeking a Process Microbiology Specialist to support biotechnology manufacturing in a cGMP environment. You will oversee a robust product protection program against adventitious agents and collaborate with Operations, QC Microbiology, Engineering, and other TS/MS scientists to guide testing strategies and investigations.

Responsibilities include monitoring in-process microbiological data, generating and maintaining documentation, leading deviation investigations, and