(Sr) Technician, Downstream Process

Job Description

Job Description

About GenScriptFounded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

About ProBio:

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

About the job:

The (Sr) Technician, Downstream Process will work within the Downstream Processing group and performs the following activities while executing Downstream operations:

• Preparation of stock solutions, and buffers.
• Filtration of stock solutions and buffers.
• Operates all production equipment in assigned functional area such as single use chromatography systems, chromatography columns, other disposable Bioprocess equipment, and solution preparation equipment as per written procedures.
• The (Sr) Technician, Downstream Process supports relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Location: Pennington, NJ

Responsibilities:

• Executes routine complex manufacturing assignments per written procedures; recognizes deviations from procedures and raises issue to management for resolution.
• Adheres to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
• Performs routine microbial and mammalian purification. Monitors chromatography and tangential flow filtration (TFF) systems during processing.
• Weighs and checks raw materials, assembles process equipment, and monitors processes.
• Completes work instructions and maintains clean room environment to comply with regulatory requirements
• Operates all production equipment in assigned functional area such as single use chromatography systems, chromatography columns, other disposable Bioprocess equipment, and solution preparation equipment as per written procedures.
• Authors solution preparation Master Batch Records (MBRs) by transferring technical information from scientific and development documents.
• Proposes and routes revisions to existing SOP's for functional area equipment.
• Works to become proficient on common bioprocessing equipment.
• Conducts Safety and GMP self-auditing walkthroughs, documenting observations for assignment and closure dates. Tracks and ensures closure of observations.
• Logs and submits samples in Laboratory Information Management System (LIMS); tracks results and compiles data.
• Reviews own work for completeness on executed Master Batch Records (MBRs).
• Coordinate the tracking and return of executed records to Quality department for review.
• Coordinates with Logistics to ensure needed materials are delivered to the production area timely. Monitors future needs against material supply to alert Logistics of shortfalls.
• Performs other tasks and assignments as needed and specified by management.

Qualifications:

• Bachelor's degree in science or engineering with a 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.

The estimated pay range for the role is between $60,000 - $75,000 based on qualifications and experience.

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Benefits:

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure 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.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.