Senior Microbiology Scientist - Biopharma Process

Celltrion Branchburg; Branchburg Township (NJ); Hybrid; USD 87,000 - 150,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) retirement plan

Wellness programs

Short- and long-term disability

Job summary

Celltrion Branchburg, LLC is seeking an experienced microbiologist to provide process microbiological support for biotechnology manufacturing within a cGMP environment. This role collaborates with Operations, QC Microbiology, Engineering, and QA to manage risk-based assessments and improvements.

Responsibilities include monitoring trends, leading deviations, and developing acceptance criteria, with travel up to 10% and hybrid work flexibility.

Qualifications

• B.S. in Microbiology or related field with cGMP biopharmaceutical experience.
• Experience in aseptic manufacturing operations and microbiology assay development/validation.
• Strong data-driven decision-making and problem-solving abilities.
• Excellent cross-functional teamwork and communication skills.
• Ability to write technical reports and investigations.
• Experience leading deviation investigations.

Responsibilities

• Monitor process microbiological data and present analyses in manufacturing team meetings.
• Provide on-the-floor microbiological support and maintain manufacturing documentation.
• Lead deviation investigations and troubleshoot contamination incidents.
• Collaborate with Operations and Engineering to implement improvements mitigating risk points.
• Provide microbiology guidance on facility and process-related controls and changes.
• Oversee process contamination prevention and control per Product Protection.
• Develop in-process microbiological acceptance criteria and sampling requirements.
• Serve as SME for evaluation and mitigation of microbiological trends.
• Support hold time studies and small-scale studies for process validation.

Skills

Data-driven decisions

Problem solving

Cross-functional teamwork

Strong communication

Technical writing

Interpersonal skills

Education

B.S. in Microbiology or related field

Job description

Celltrion Branchburg, LLC is seeking an experienced microbiologist to provide process microbiological support for biotechnology manufacturing within a cGMP environment. This role collaborates with Operations, QC Microbiology, Engineering, and QA to manage risk-based assessments and improvements.

Responsibilities include monitoring trends, leading deviations, and developing acceptance criteria, with travel up to 10% and hybrid work flexibility.