Sr. Scientist/Engineer - Process Microbiology

Celltrion Branchburg, LLC•Branchburg Township, NJ

5d•$87,000 - $150,000

About The Position

This position provides process microbiological support for biotechnology manufacturing processes, oversees a robust Product Protection Control Strategy against adventitious agents in a cGMP environment, and builds organizational knowledge of aseptic manufacturing operations. The role partners with Operations, QC Microbiology, Engineering, other TS/MS Scientists, and Quality on risk-based assessments, testing strategies, and troubleshooting. The position monitors and analyzes in-process microbiological data, provides on-the-floor support, supports investigations and contamination troubleshooting, and helps implement improvements to reduce microbiological risks. It also oversees process contamination prevention and control, develops in-process microbiological criteria and procedures, and serves as a subject matter expert on microbiological trends. The role supports technology transfer, hold-time and small-scale studies, process validation activities, cleaning and SIP validation, facility and equipment qualification, and site environmental monitoring and clean utilities microbiology programs. It is an exempt, banded role with anticipated compensation of $87,000–$150,000. Hybrid flexibility may be available based on business needs; relocation assistance is not provided.

Requirements

Knowledge of aseptic manufacturing operations.
Strong investigative skills and working knowledge of microbiology assay development and validation.
Demonstrated data-driven decision-making and problem-solving capabilities.
Strong interpersonal skills in a cross-functional teamwork environment.
Strong oral and written communication skills, including technical writing of position papers, validation reports, and microbiological investigations.
Ability to participate in and facilitate decision-making.
B.S. in Microbiology or a related science.
0–7 years of experience in a cGMP biopharmaceutical manufacturing environment; education and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be considered for placement within the band.

Responsibilities

Monitor and trend in-process microbiological data and present analyses in Manufacturing Process Team meetings.
Provide on-the-floor microbiological support for manufacturing processes, including generating and maintaining support documentation such as SOPs, trend analyses, and evaluation protocols.
Assist with or lead deviation investigations and troubleshoot suspected microbiological contamination incidents.
Collaborate with Operations and Engineering to implement equipment, procedure, or automation improvements that mitigate identified microbiological risk points.
Provide microbiology guidance on facility- and process-related controls and changes.
Oversee process contamination prevention and control according to the Product Protection Control Strategy.
Develop in-process microbiological acceptance criteria, sampling requirements, summations, procedures, and reports; collaborate with QC Microbiology on specifications and the microbiological control strategy.
Serve as a subject matter expert for evaluation and mitigation of microbiological trends.
Support microbiological requirements for in-process hold-time studies and small-scale studies supporting hold time, resin cleaning, and other process validation activities.
Collaborate with Validation Technical Services on microbiological requirements for cleaning/SIP validation and facility and equipment qualification.
Collaborate with Quality Control on development and execution of facility-based environmental monitoring and clean utilities microbiology programs.
Build deep technical expertise in the area of responsibility.