Laboratory Analyst II - III

Onsite; this is not a remote position

Operating in CS Analytical’s cGMP, FDA-registered laboratory in Clifton, NJ, the Laboratory Analyst II - III is responsible for executing client testing and supporting overall laboratory operations. This position brings an intermediate to advanced level of technical experience to independently execute projects, author protocols and reports, and support junior staff. Title, level, and responsibilities will be determined by the candidate’s experience and demonstrated technical expertise.

This role focuses on analytical chemistry testing of raw materials and finished products, as well as container qualification. All duties and responsibilities below fall within this scientific focus.

Analyst II - III Responsibilities

Responsibilities are scaled to the level at which the candidate is placed. Analyst III responsibilities include the full scope below.

• Perform analytical testing on raw materials, finished products, containers, and stability samples using advanced chromatographic techniques, including HPLC, GC (liquid and headspace), and ICP-MS.
• Support other wet chemical analysis testing as needed.
• Perform routine preventive maintenance (PM) and serve as the subject matter expert for chromatographic instrumentation.
• Serve as system owner for a broad range of complex instrumentation, maintaining SOPs, ERs, calibration, and qualification, including new systems as they are introduced.
• Perform basic and complex analyses and measurements, including development, R&D, internal projects, and investigations.
• Scope new work from a technical perspective, supporting lab management and Business Operations in determining and acquiring supplies for each study.
• Independently author technical protocols, WIPs, and test methods, coordinating internally and externally for document approvals.
• Act as the primary laboratory representative for quality events and investigations, such as deviations, OOS, and OOT.
• Assist the management team in completing laboratory quality events, such as OOS investigations and deviations.
• Assist with technical peer review for data acquired by other team members.
• Train peers in advanced chromatographic testing as needed.
• Oversee and support junior staff with day-to-day operations, training, and requests for assistance.
• Perform laboratory peer review of analyst work.
• Contact clients for updates or clarifications as directed by a project lead or laboratory management.
• Assist with all other duties as assigned.

General Responsibilities

• Maintain the cleanliness of the immediate work environment.
• Work with Lab, QA, and Business Operations to ensure chemicals, materials, and supplies are available by inventorying stock, placing orders upon request, and verifying receipt.
• Assist with sample intake, disposal, shipping, and receiving as required.
• Document all information by maintaining LIMS records, electronic lab notebook entries, and Qualio documents (such as ERs) as necessary.
• Keep job knowledge current by participating in educational opportunities, seeking training on new instruments and test methods, and reviewing relevant industry guidance and documentation.
• Take ownership of new and different requests, and explore opportunities to add value to overall laboratory operations.

Qualifications

Education

• Bachelor’s degree in chemistry or a related field, with 3+ years of relevant experience, or
• Master’s degree in chemistry or a related field, with 1+ years of relevant experience, or
• PhD in chemistry or a related field, with 0-2 years of relevant experience.

Required Experience and Skills

• Experience in a QC laboratory or similar setting.
• Prior work experience in a cGMP laboratory.
• Hands-on experience with GC and HPLC (advanced expertise expected at the Analyst III level).
• Ability to troubleshoot instrumentation, such as GC, LC, and ICP-MS.
• Ability to adhere to procedures and guidelines associated with a cGMP, FDA-registered environment.
• Strong attention to detail.

Preferred

• Experience with Waters Empower chromatography software.

This is NOT a remote position. You will be working onsite at our Clifton, NJ facility.

To Apply, please send a cover letter and resume to [email protected]