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QC Scientist
14 Schoolhouse Road East Millstone, NJ 08873 US
Job Description
Responsibilities:
- Perform Finish product Testing (Stability, development), QC release and data review.
- Perform, Assay, related substances, KF, Dissolution, disintegration, Hardness.
- Work on lab instruments (HPLC/GC/UPLC, KF, Dissolution, Hardness, disintegration).
- Perform test and report data as per the Catalent approved procedures.
- Analyst will follow the internal methods, SOPs, procedures, monographs to perform the testing.
- Work on DEA controlled substance.
- Conduct Laboratory investigation using the TrackWise system following SOPs and Procedures.
- Perform Opex activities, data trending, SOPs revisions, as assigned.
- The Scientist reports to the Quality Control & Analytical Product Development, Manager/Senior Scientist/Principal Scientist. The Scientist will be performing routine analysis of Finish products using laboratory techniques and instrumentation such as HPLC, Dissolution, Karl Fisher, pH meter. Analyst will perform Assay, Content Uniformity, Blend Uniformity, Moisture testing, related substances, dissolution on finish product.
- Analyst will test In Process and FP samples and test stability samples at different ICH conditions.
- Our Somerset location is our corporate headquarters. This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to be the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients.
The Role
- Under the supervision of other Scientists, carry out activities in support of the manufacturing of pharmaceutical products. These activities include in-process testing, finished product testing, sample analysis, and physical evaluation of products.
- Conduct experiments which includes scope from R&D to clinical and commercial release
- Perform Assay/Related Substances, Karl Fisher, Dissolution, Hardness, Disintegration etc.
- Instrumentation techniques: HPLC,GC, UPLC, Dissolution, UV, KF
- Assist other Scientists, as necessary for timely project completion and support other lab personnel as required.
- Follow regulatory guidelines, SOPs, cGMPs and Laboratory procedures.
- All other duties as assigned.
The Candidate
- Bachelor of Science in Analytical Chemistry/Pharmaceutics with equivalent industry experience
- Master of Science in Analytical Chemistry/Pharmaceutics preferred
- 3 or more years of applicable industry experience in support of pharmaceutical product development
- Expertise in Instrumentation techniques: HPLC, GC, FTIR, UV, KF, and other wet chemistry testing.
- Experience with GMP and ICH regulations
- Requires excellent written and verbal communication
- Candidate must be comfortable in a fast-paced work environment
- Mathematical and reasoning ability
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to work effectively under pressure to meet deadlines.
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
Pay Rate Range: $30-40/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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