- Perform QC biochemistry assay validation and transfer activities, including testing (e.g., DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
- Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, testing record keeping, etc.
- Manage inventory of reagents and supplies for the laboratory.
- Lead investigations of OOS, discrepancies, errors, failures requiring documented review and action.
- Participate in internal and external GMP audits where possible.
- Lead method transfer and method validation activities, prepare protocols and reports.
- Train other junior level analysts and new hires.
- Subject matter expert in one or more areas of required testing.
- Undertake any other duties as required.
- Minimum of 2+ years with a bachelor's or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline. 5+ years of experience preferred.
- Working experience in an FDA-regulated biotechnology, pharmaceutical company are required.
- Serve as subject matter expert for residual DNA by qPCR, host cell protein ELISA, Residual Protein A ELISA, binding activity ELISA, Capillary Electrophoresis (CE), and capillary isoelectric focusing electrophoresis(cIEF), including qualification, assay validation and transfer activities.
- Working knowledge with USP/EP and cGMP/EU GMP.
- Familiar with instrument and equipment validation.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Strong leadership/team management skills and experience.
- Credible and confident communicator (written and verbal) at all levels.
- Strong analytical and problem-solving ability.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Committed to learning and development.
- MS Office skills (Outlook, Word, Excel, PowerPoint)
-
QC Biochemistry Analyst
6 days ago
Snelling Staffing El Paso, Texas Hopewell, United StatesDuties: · Perform QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures. · ...
-
QC Biochemistry Analyst
1 week ago
Planet Pharma Hopewell, United States6-month initial contract · 3 openings · Perform QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, ...
-
QC Biochemistry Analyst
2 weeks ago
Planet Pharma Hopewell, United States6-month initial contract · 3 openings · Perform QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, c ...
-
QC Biochemistry Analyst
2 weeks ago
Snelling Staffing El Paso, Texas Hopewell, United StatesDuties: · Perform QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures. · E ...
-
QC Biochemistry Analyst
1 day ago
Innova Solutions Pennington, United StatesInnova Solutions is immediately hiring for a n QC Biochemistry Analyst · Position type: Full-time; Contract · Duration: 06+ Months · Location: Pennington, NJ · Pay range: $ 45 - $ 50 /hr on W2 · As a QC Biochemistry Analyst Professional you will: · Job Description: · Perf ...
-
Quality Control Biochemistry Analyst
2 weeks ago
GroupA Hopewell, United StatesQuality Control Biochemistry Analyst · We are looking for a Quality Control Biochemistry Analyst to join our team on-site in Hopewell, NJ. You will be responsible for QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and rel ...
-
Analytical Development Analyst
2 weeks ago
Randstad Life Sciences US Hopewell, United StatesTitle: Analytical Development Analyst · Duration: 12 Months · Pay Rate: $48/hr on W2 · Location: Hopewell, NJ · Duties: · Perform analytical tests to support process development and transfer analytical methods to QC department. · Essential Functions of the job: · Write SOP, exper ...
-
Analytical Development Analyst
2 weeks ago
Randstad Life Sciences US Hopewell, United StatesTitle: Analytical Development Analyst · Duration: 12 Months · Pay Rate: $48/hr on W2 · Location: Hopewell, NJ · Duties: · Perform analytical tests to support process development and transfer analytical methods to QC department. · Essential Functions of the job: · Write SOP ...
-
Analyst, Analytical Development
1 week ago
IT Solutions LLC Hopewell, United StatesJob Title: Analyst, Analytical Development · Onsite: Hopewell Site · Department: Analytical Development · Reports To: Manager - US Site · Full-Time Hours: 40 hours/week · OT: Over-Time may be required on occasion · DUTIES · Perform analytical tests to support process development ...
-
Analytical Chemist
2 weeks ago
Ivory Systems Hopewell, United StatesJob Title: Analyst, Analytical Development · Education Required: · Minimum of 2+ years working experience with a bachelor's or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline. · General Description: · Perform analytical tests t ...
-
Senior Biohemistry Analyst
2 weeks ago
Kelly Services, Inc. Princeton, United StatesKelly Science is seeking a Senior Biochemistry Analyst for a consultation position for a growing company located near Princeton, NJ. Pay: $50-60/hour depending on experience Employment Type: 6 month contract with possible extension Job Duties: Perfor Analyst, Chemistry, Senior, O ...
-
Biochemist
1 week ago
Kelly Science, Engineering, Technology & Telecom East Brunswick, United StatesJob Title: Senior QC Biochemistry Scientist · Essential Functions: · Lead and execute QC biochemistry assay validation and transfer activities, including testing for Drug Substance, Drug Product release, and stability testing, ensuring timely generation and reporting of test resu ...
-
Scientist - I (Assistant)
2 weeks ago
eTeam Inc Rahway, NJ, United States*NIT1* · About the company · eTeam was formed in 1999 with the goal of becoming the company of choice for clients, talent and staffing professionals. Today, we're one of the fastest-growing global companies and ranked as one of the best companies to work for by Staffing Industry ...
-
Validation Engineer
2 weeks ago
NavitsPartners Lansdale, United StatesJob Description · Job Description · Position: Validation Engineer - II · Location: West Point, PA · Duration: 12 Months · Note: · M-F/40hrs/week-100% onsite. · Job Description: · Candidate will work within the PCD metrology team that supports regulated equipment and systems ...
-
Analyst, Laboratory Quality Control
5 days ago
J&J Family of Companies Raritan, United StatesAnalyst, Laboratory Quality Control (1 of W · Description · Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Laboratory Quality Control - CAR-T in Raritan, NJ · At the Janssen Pharmaceutical Companies of Johnson ...
-
Summer Lab Interns- multiple openings
2 weeks ago
NMS Labs Horsham, United StatesReference #: 1952 Title:Summer Lab Interns Department: various Job Type:Temporary Full Time Location: Horsham, PA Shift: Monday through Friday 8:00 am to 4:30 pm · Company Summary: · NMS Labs has developed an extensive menu of more than 2,500 tests to support clients in forensic, ...
-
QC Analyst I/II
1 week ago
Kashiv BioSciences LLC Plainfield, United StatesThe QC Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. A strong background in protein chemistry will be essential to perform and t ...
-
QC Analyst I/II
1 week ago
Kashiv BioSciences LLC Plainfield, United States· The QC Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. A strong background in protein chemistry will be essential to perform an ...
-
Senior Automation Scientist
2 days ago
American Cybersystems New Brunswick, United StatesAMERICAN CYBERSYSTEMS INC. · Senior Automation Scientist · New Brunswick , · New Jersey · Apply Now · Innova Solutions is immediately hiring a Senior Automation Scientist (Analytical lab instruments) Job Title: Senior Automation Scientist (Analytical lab instruments) Positio ...
-
Automation Scientist
1 day ago
Primary Talent Partners, Inc. New Brunswick, United States1 week ago · Be among the first 25 applicants · Primary Talent Partners has a 12-month contract opening in New Brunswick, NJ for an Automation Scientist to join a great pharma client of ours. This is an on-site position. · Pay Rate = $ $50.00 · Top Must Have's that must be det ...
Quality Control Biochemistry Analyst - Hopewell, United States - GroupA
Description
We are looking for a Quality Control Biochemistry Analyst to join our team on-site in Hopewell, NJ. You will be responsible for QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, company processes and procedures.
Key Responsibilities:
Requirements:
Travel: Must be willing to travel approximately 10%
