Celltrion Inc · 1 day ago
Scientist/Engineer Process Microbiology
Branchburg, NJ
Full-time
Hybrid
New Grad, Entry, Mid Level
$72K/yr - $116K/yr
0+ years expCelltrion Inc is focused on biotechnology manufacturing and is seeking a Scientist/Engineer in Process Microbiology. This role is responsible for contamination control support in a cGMP environment, collaborating with various teams to implement strategies and troubleshoot microbiological issues.
Health CarePharmaceutical
Responsibilities
Monitors (trends) in-process microbiological data and presents analyses in Manufacturing Process Team meetings
Provide on-the-floor contamination control support for manufacturing processes including generation and maintenance of manufacturing support documentation (e.g. SOPs, trend analyses, evaluation protocols)
Assist/Lead deviation investigations. Troubleshoot suspected microbiological contamination incidents
Collaborate with Operations and Engineering to implement equipment, procedure and/or automation improvements to mitigate identified contamination risk points
Provide contamination control guidance on facility and process-related controls and changes
Oversee process contamination prevention and control according to Product Protection Control Strategy
Develop in-process microbiological acceptance criteria, sampling requirements, summations, procedures, and reports. Collaborate with QC Microbiology on specifications and microbiological control strategy
Serve as subject matter expert for evaluation and mitigation of microbiological trends
Support microbiological requirements for in-process hold time studies as well as small-scale studies to support hold time, resin cleaning, and other process validation activities
Collaborate with Validation Technical Services on microbiological requirements for cleaning/SIP validation and facility/equipment qualification
Collaborate with Quality Control in the development and execution of the facility-based environmental monitoring and clean utilities microbiology programs for the site
Build deep technical expertise in the area of responsibility
Qualification
Required
Knowledge of aseptic manufacturing operations
Strong investigational skill, working knowledge of microbiology assay development and validation
Demonstrated strong data-driven decision-making and problem-solving capabilities
Demonstrated strong interpersonal skills in cross-functional teamwork environment
Demonstrated strong communication skills, both oral and written. Technical writing including position papers, validation reports, and microbiological investigations
Demonstrated ability to participate in and facilitate decision-making
B.S. in Microbiology or related science or engineering with a minimum of 0-5 years experience in a cGMP biopharmaceutical manufacturing environment
Benefits
Paid time off (holidays, vacation, and additional leave)
Medical, dental, and vision insurance
Life insurance
A company-matched retirement savings plan
Wellness programs
Short- and long-term disability benefits
Company
Celltrion Inc
Celltrion is a fully integrated biopharmaceutical company dedicated to delivering innovative and affordable medications to improve patients’ access to advanced therapies.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-08-17Acquired
2017-07-28IPO
Recent News
2025-12-31
Company data provided by crunchbase