Chemist

ONSITE - ASSIGNMENT DURATION - 6 + MONTHS - SHIFT - MON-FRI 8AM - 5PM.

This position supports laboratory data auditing that includes reviewing the technical documents like protocols/reports/test methods, specifications, and the SOPs etc. related to AR&D with minimum supervision from the supervisor. Employees at this level can manage their time effectively while executing a broad range of high visibility tasks to provide scheduling and alignment for the AR&D Department in support of internal and external customers. This position requires strong knowledge of technical and analytical requirements of AR&D laboratory.

Analytical R&D Auditors are responsible for performing technical review of raw material/in process/finished good data for release and stability along with other protocol-based studies that are executed in AR&D for regulatory submissions. In addition, the responsibilities include supporting lab investigations, customer/agency audits and performing analytical testing as per business needs.

II. Specific Tasks & Duties

• Read and understand test methods from multiple compendia (i.e., USP/NF, EP, JP), internal Catalent methods, customer/supplier methods and other technical documents.

• Perform technical review and approval of all data including notebooks/certificate of analysis, stability summaries etc. for compliance with approved test methods, specification, and applicable internal SOPs for routine release testing of raw materials, in-process samples, finished products and stability samples for development batches, GMP/clinical batches and registration activities required for the regulatory submissions.

• Perform technical review and approval of data, protocols and reports related to method qualifications (transfers/verifications/validations) including other protocol-based studies (photostability, comparative dissolution studies, dose dump studies etc.) performed in AR&D required for regulatory submissions.

• Author / review SOP’s that fall within defined area of subject matter expertise. Review other technical documents not limited to specification, test methods, Certificate of analysis/Report of analysis, protocols/reports, and other technical documents as needed.

• Participate in customer/internal/regulatory agency audits as necessary.

• Assist in training analytical scientists.

• Perform analytical testing as per business needs.

• Assist in laboratory investigations.

• Draft or review CAPAs and audit responses as needed.

III. Essential Skills and Experience:

Education or Equivalent:

• Ph.D., M.S, or B.S in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry).

o Work Experience – 3+ years of pharmaceutical industry experience with a Ph.D. degree, and with at least 2 years of analytical testing/research experience using HPLC/GC/UV, etc.

o Work Experience – 4+ years of pharmaceutical industry experience with a M.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.

o Work Experience – 5+ years of pharmaceutical industry experience with a B.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.

Knowledge/Skills Requirements:

• Understand analytical chemistry calculations such as concentrations (Area%, %w/w, ppm, µg/mL, etc.), molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis etc.

• Ability to multi-task with high efficiency.

• Ability to coordinate and prioritize to support manufacturing and quality agreements.

• Ability to work well under pressure and maintain efficiency both on an individual and team basis.

• Ability to communicate effectively.

• Strong knowledge in Empower software.

• Advanced knowledge and demonstrated performance in regard to all lab safety process and procedures and the ability to work safely with chemicals of varying potency.