Job description

Job description

We are growing and need to hire for all positions. Join the dynamic team at Scientech Laboratories, a contract analytical laboratory for the pharmaceutical, nutraceutical, and cosmetic industries, located in Central New Jersey.

EXPERIENCED ANALYTICAL CHEMIST. (Chemist II)

We are looking for a highly qualified individual with extensive experience in overseeing the technical operations of a state-of-the-art cGMP laboratory. In-depth knowledge of FDA/CMC regulations and ICH, and USP compliance. Extensive experience in managing projects and timelines with CMO, CRO, and Contract labs. Thorough knowledge of analytical methods development and validation; reference standard qualification; implementation of quality systems; implementation of emerging new technologies; setting in-house specifications for raw materials and finished products. Must have strong communication and organizational skills, and be capable of handling multiple tasks and projects within specific deadlines.

Required Skills, Knowledge, and Abilities

Must have experience in running an analytical testing laboratory, including directing and managing all activities including:

• In-depth knowledge of cGMP regulations, governing analytical testing for pharmaceutical, nutraceutical, and cosmetic clients.
• Proven ability to interact affirmatively with regulatory authorities, such as FDA.
• Extensive experience with analytical instrumentation such as HPLC,GC, UV, FTIR, AA, ICP-MS.
• Working knowledge of compendial methods and international standards such as USP, AOAC, EP, BP, JP, ICH, etc.
• Proven experience with Method Development and Method Validation/Verification.
• Past experience with developing and writing method protocols and standard operating procedures.
• Experience with the procurement of lab equipment.
• Experience with establishing systems for cGMP compliance.
• Experience in preparing control documents such as Monographs, Specifications, Protocols, Reports, SOPs, OOS, OOT investigations, Change Controls, CMC section for ANDA submissions, and responses to FDA deficiencies.
• Experience in the testing of packaging systems for liquid and solid dosage forms (USP Extractable/Leachable, USP1663, 661, and 671) and Elemental Impurities (USP 232, 233).
• Must have knowledge of current industry standards: USP/EP/ICH/cGMP and FDA.
• Must have experience with troubleshooting and maintenance of modern analytical instruments such as HPLC, UPLC, LC/MS, GC, GC/MS, ICP-MS, GPC, TGA/DSC, AA, UV-vis., FTIR.
• Experience with Methods Development and Validation for in-process finished and stability products in compliance with cGMP, USP, and ICH guidelines.
• Experience with processes of ANDA submissions.
• Experience with Impurity profiles for drug substances.
• Experience with writing and Reviewing Validation reports for FDA submissions.
• Exceptional oral and communication skills, and the ability to understand the technical and regulatory needs of new and existing clients.
• Proven team player with extensive troubleshooting experience.

Education and Work Experience

• M.S., or Ph.D. in Analytical Chemistry or similar field.
• 10 Plus years of working experience working in an analytical laboratory, for Pharma, or related industry.
• Must have extensive experience with running and managing the demands of a modern laboratory.
• Must be self-motivated, innovative, creative, and possess a positive, can-do attitude.
• Must be willing to work both independently and as a team player, as circumstances warrant.
• Ability to multitask and managed several projects simultaneously.

The position offers an excellent salary, major benefits, and the opportunity to advance to positions of higher responsibility with advanced wages and bonuses.

Job Type: Full-time

Pay: $62,500 - $68,800 per year

Job Type: Full-time

Pay: $62,547.00 - $68,000.00 per year

Benefits:

• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Evening shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• South Plainfield, NJ 07080: Reliably commute or planning to relocate before starting work (Required)

Experience:

• CGMP: 5 years (Required)

Work Location: One location

arclintfl.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, arclintfl.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, arclintfl.com is the ideal place to find your next job.