Manufacturing Scientist

Global Life Science Hub is seeking a Manufacturing Scientist for a prominent biotech client located in Piscataway, NJ. This role is critical in supporting both upstream and downstream manufacturing processes for high-quality biotech products intended for clinical and commercial use.

Shift Hours: Monday – Friday, 10:00 pm – 6:00 am

Key Responsibilities:

• Bioreactor Operations: Monitor and manage bioreactor performance during the night shift, covering 70% of shift responsibilities.
• Documentation & SOPs: Author, review, and update Standard Operating Procedures (SOPs) and support the preparation of production systems, batch records, and related documentation in line with cGMP requirements.
• Upstream Support: Involve in fermentation and inoculation processes, utilizing expertise in upstream manufacturing to support the bioreactor and buffer/media preparation.
• Downstream Process Support: Assist with downstream activities, such as cleaning chromatography columns, performing sampling, and conducting essential protein purification steps.
• Quality Compliance: Collaborate with Quality and Compliance teams during regulatory audits, ensuring data integrity and adherence to regulatory standards.
• Calibration & Equipment Maintenance: Handle the calibration and verification of lab equipment, including pH/conductivity meters, osmometers, and scales.
• Data Compilation & Logbook Review: Compile process data and conduct logbook verification to ensure all documentation meets internal and external regulatory standards.
• Routine Cleaning: Participate in routine cleaning of production areas, ensuring adherence to cleaning validation programs.

Qualifications:

• Education: Bachelor’s or Master’s degree in Chemistry, Biology, Biochemistry, or a related field.
• Experience: Minimum of 2 years in biopharmaceutical manufacturing, particularly in both upstream and downstream processes within a cGMP environment.
• Specialized Skills: Experience with fermentation, protein purification, aseptic processing, and an understanding of both drug substance and drug product manufacturing.

Desired Skills:

• Proficiency in MS Word, Excel, PowerPoint, and Outlook; familiarity with experimental design, data collection, and statistical analysis.
• Strong verbal and written communication skills, with a high attention to detail and quality orientation.
• Ability to troubleshoot and resolve technical issues, exercising independent judgment for projects of significance.
• Prior experience as a Certified Quality Auditor (CQA) or in Risk Assessment (RA) and Failure Mode Analysis (FMAE) is beneficial but not required.

Work Environment & Physical Demands:

• Flexibility: Schedules may vary based on production needs, and holiday coverage may be required, rotating fairly among team members.
• Physical Requirements: Must be capable of lifting up to 50 lbs and moving within the facility to operate equipment.