Back to jobs

Bioprocess Specialist, Downstream Processing

Pennington, NJ

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology

About ProBio

ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, \ProBio has a stable and high-yield viral vector platform.

Job Scope:

The Bioprocess Specialist works within the Downstream Processing group.  The Bioprocess Specialist will perform the following activities while executing downstream operations:

 

·       Preparation of solutions

·       Filtration

·       Chromatography

·       Tangential flow filtration

·       Homogenizing

·       Drug substance formulation

·       Drug product formulation

·       Drug product vial filling

The incumbent works cross-functionally with internal departments and external resources on gene therapy manufacturing related issues. 

 

The incumbent supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

Position Information:

Worl Location: Pennington, NJ

Reports to: Senior Manager, Downstream Process

 

Roles and 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 cell culture using aseptic techniques.  Monitors microbial fermenters and mammalian cell cultures bioreactors.
  • Weighs and checks raw materials, assembles process equipment, and monitors processes.
  • Completes work instructions and maintains clean room environment to comply with regulatory requirements. Removes red bag waste as required.
  • Operates all production equipment in assigned functional area such as disposable fermenters, bioreactors, other disposable Bioprocess equipment, and media 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.
  • Participates in low risk deviations investigations. Assists in the implementation of Corrective Action / Preventative Actions (CAPA) action items within agreed upon timelines.
  • 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. 

 

#LI-SL3

#PB

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.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...

U.S. Standard Demographic Questions

We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in GenScript/ProBio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.