Scientist - Quality Control & Analytical Product Development
BCforward is currently seeking highly motivated Scientist - Quality Control & Analytical Product Development
Title: Scientist - Quality Control & Analytical Product Development
Location: Somerset, NJ
Duration: 6+ months Contract
Job Type: Contract
Anticipated Start Date: ASAP
(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.)
Job Type: Contract (40 hrs. a week)
Pay Rate: $39/hr
Please note that actual compensation may vary within this range due to factors such as location, experience, and job responsibilities, and does not encompass additional non-standard compensation (e.g., benefits, paid time off, per diem, etc.).
Key Responsibilities
Analytical Testing: Perform assays, dissolution, hardness tests, water content, content/blend uniformity, and related substances using wet chemistry as per compendial monographs.
Laboratory Analysis: Conduct analytical testing of excipients, APIs, in-process, and finished pharmaceutical products, including stability testing under ICH conditions.
Instrumentation: Operate and maintain lab instruments such as HPLC, GC, UPLC, Karl Fischer (KF), dissolution apparatus, hardness tester, and disintegration apparatus.
Data Management: Perform tests, record and report data as per approved procedures, and conduct data review, trending, and laboratory investigations (TrackWise system).
Regulatory Compliance: Follow SOPs, cGMP guidelines, and regulatory procedures while ensuring adherence to internal methods and monographs.
Team Collaboration: Assist other scientists to ensure timely project completion and provide support to lab personnel as required.
Special Projects: Perform operational excellence activities, SOP revisions, and other assigned tasks.
Role Highlights
Perform stability and QC release testing on finished products.
Conduct experiments from R&D to clinical and commercial release.
Work with DEA-controlled substances following regulatory procedures.
Ensure compliance with ICH and GMP regulations.
Qualifications
Education:
Bachelor's degree in Analytical Chemistry, Pharmaceutics, or related field.
Master's degree preferred.
Experience:
Minimum 3 years of industry experience in pharmaceutical product development.
Expertise in analytical techniques including HPLC, GC, UPLC, FTIR, UV, KF, and wet chemistry.
Skills:
Strong knowledge of GMP and ICH regulations.
Excellent written and verbal communication skills.
Ability to interpret instructions in various formats (written, oral, diagram, schedule).
Proficiency in data analysis and problem-solving under tight deadlines.
Physical Requirements:
Ability to sit, stand, walk regularly, and occasionally lift 0-15 pounds.
Interested candidates please send resume in Word format Please reference job code 232251 when responding to this ad.
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