Current jobs related to Bioprocess Specialist - Hopewell, New Jersey - GenScriptProBio

We are seeking a highly skilled Bioprocess Specialist - Upstream Processing to join our team at GenScript/ProBio. As a key member of our Upstream Processing group, you will be responsible for executing upstream operations, including preparation of stock solutions, buffers, and media, filtration of stock solutions, buffers, and media, and set-up and operation of disposable fermenters/bioreactors and other disposable bioprocess equipment.

• Execute routine complex manufacturing assignments per written procedures, recognizing deviations from procedures and raising issues to management for resolution.
• Adhere to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
• Perform routine microbial and mammalian cell culture using aseptic techniques, monitoring microbial fermenters and mammalian cell cultures bioreactors.
• Weigh and check raw materials, assemble process equipment, and monitor processes.
• Complete work instructions and maintain a clean room environment to comply with regulatory requirements, removing red bag waste as required.
• Operate all production equipment in assigned functional area, such as disposable fermenters, bioreactors, other disposable bioprocess equipment, and media preparation equipment, as per written procedures.
• Author solution preparation Master Batch Records (MBRs) by transferring technical information from scientific and development documents.
• Propose and route revisions to existing SOPs for functional area equipment.
• Work to become proficient on common bioprocessing equipment.
• Participate in low-risk deviations investigations, assisting in the implementation of Corrective Action/Preventative Actions (CAPA) action items within agreed-upon timelines.
• Conduct Safety and GMP self-auditing walkthroughs, documenting observations for assignment and closure dates, tracking and ensuring closure of observations.
• Log and submit samples in Laboratory Information Management System (LIMS), track results, and compile data.
• Review own work for completeness on executed Master Batch Records (MBRs).
• Coordinate the tracking and return of executed records to Quality department for review.
• Coordinate with Logistics to ensure needed materials are delivered to the production area timely, monitoring future needs against material supply to alert Logistics of shortfalls.

• Bachelor's degree in science or engineering with 0-5 years relevant experience, or an associate's degree in science or engineering with a minimum of 3 years relevant experience, or a high school diploma with a minimum of 7 years relevant experience.
• Demonstrated ability to follow written instructions and procedures.
• Demonstrated ability to pay strict attention to detail.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication and skills.
• Ability to work collaboratively as part of a team, in a fast-paced, matrixed, team environment consisting of internal and external team members.

GenScript/ProBio is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We are committed to ensuring equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.