Bioprocess Specialist, Downstream Processing
1 month ago
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.
-
Process Development Scientist
2 weeks ago
Pennington, United States EPM Scientific Full timeWe are currently working with a Gene Therapy company that are looking for a Scientist/Engineer to join their process development downstream team.The successful applicant will have experience in laboratory research, and a desire to continue in a laboratory-focused role. This position will join a team of scientists/engineers focused on developing and...
-
Sr. Automation Engineer, GMP
2 weeks ago
Pennington, United States GenScriptProBio Full timeJob DescriptionJob DescriptionAbout GenScriptGenScript 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...
-
Sr. Automation Engineer, GMP
3 weeks ago
Pennington, United States GenScriptProBio Full timeAbout 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...
-
Distributed Database Specialist
4 weeks ago
Pennington, New Jersey, United States Tata Consultancy Services Full timeJob Title: Distributed Database SpecialistLocation: VariousRoles & Responsibilities:•Proficiency in both SQL Server and CockroachDB database skills.•Deep understanding of distributed database systems.•Proficiency in database schema design, code development, and transformation.•Ability to anticipate potential roadblocks and design mitigation...
-
Clinical Care Specialist
6 days ago
Pennington, New Jersey, United States Capital Health Full timeAbout This RoleCapital Health is seeking a highly skilled Clinical Care Specialist - Acute CT to join our team. As a key member of our healthcare team, you will be responsible for providing high-quality patient care and ensuring the best possible outcomes for our patients.Key ResponsibilitiesAssessment and PlanningYou will perform comprehensive assessments...
-
Brokerage Operations
4 weeks ago
Pennington, United States BCForward Full timeJob DescriptionJob DescriptionBCforward is currently seeking a highly motivated Operations Specialist opportunity in Pennington, NJ!Position Title: Operations SpecialistLocation: Pennington, NJ 08534Anticipated Start Date: ASAPExpected Duration: 9 monthsJob Type: FULL-TIME, CONTRACT, ONSITEPay Range: $22.28/hrWork scheduled: Monday- Friday 8:00AM -...
-
QA Technical Ops Specialist
1 month ago
Pennington, United States GenScript Full timeAbout 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...
-
IT Security Specialist
1 month ago
Pennington, United States Genesis Corp dba Genesis10 Full timeGenesis10 is currently seeking an IT Security Specialist with our client in the financial industry located in Pennington, NJ. This is a 12+ month contract position. Responsibilities: Responsible for setting up and maintaining the Machine Learning (Client) platform on client's internal infrastructure Involved in research and development efforts to choose...
-
IT Security Specialist
1 month ago
Pennington, United States Genesis10 Full timeGenesis10 is currently seeking an IT Security Specialist with our client in the financial industry located in Pennington, NJ. This is a 12+ month contract position.Responsibilities: Responsible for setting up and maintaining the Machine Learning (Client) platform on client's internal infrastructure Involved in research and development efforts to choose best...
-
Physician Leader for Acute Care
2 weeks ago
Pennington, New Jersey, United States Capital Health Full timeOverviewAt Capital Health, we are committed to delivering high-quality patient care. Our team of healthcare professionals works together to provide comprehensive medical services.SalaryWe offer an attractive salary range of $250,000 - $350,000 per year, commensurate with experience, to our Hospitalist physicians.About the JobThis is a fantastic opportunity...
-
Senior API Automation Specialist
4 weeks ago
Pennington, New Jersey, United States Tata Consultancy Services Full timeManual API Tester RoleWe are seeking a skilled Manual API Tester to join our team at Tata Consultancy Services. As a Manual API Tester, you will be responsible for testing APIs and microservices to ensure they meet the required standards.Key Responsibilities:Minimum 8+ years of strong testing experience.Minimum 3+ years of experience in Test Automation of...
-
Wound Care Specialist
2 weeks ago
Pennington, New Jersey, United States Capital Health (US) Full timeCapital Health is a Magnet-Recognized health system for nursing excellence, comprising two hospitals and a medical group with over 250 physicians. We offer primary and specialty care, as well as hospital-based services, to patients throughout the region.This per diem position plays a critical role in delivering exceptional patient care. If you are passionate...
-
NP/PA Acute
2 weeks ago
Pennington, United States Capital Health (US) Full timeJob DescriptionWork ShiftCapital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health Medical...
-
NP/PA Acute
2 weeks ago
Pennington, United States Capital Health (US) Full timeJob Description Work Shift Capital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health...
-
NP/PA Acute
2 months ago
Pennington, United States Capital Health (US) Full timeJob DescriptionWork ShiftCapital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health...
-
Hospitalist
4 weeks ago
Pennington, United States Capital Health Full timeWork Shift: Capital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health Medical Group is...
-
RN Outpatient Specialty Practice
2 weeks ago
Pennington, United States Capital Health (US) Full timeJob DescriptionWork ShiftCapital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health Medical...
-
NP/PA Acute CT
2 weeks ago
Pennington, United States Capital Health (US) Full timeJob DescriptionWork ShiftCapital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health Medical...
-
NP/PA Acute CT
2 weeks ago
Pennington, United States Capital Health (US) Full timeJob Description Work Shift Capital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health...
-
NP/PA Acute CT
2 months ago
Pennington, United States Capital Health (US) Full timeJob DescriptionWork ShiftCapital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health...
