JOB DUTIES: Support implementation/management of Laboratory Systems, including, but not limited to investigations, change controls, CAPA, inspection readiness, laboratory metrics, analytical method verification/qualification at CRO [Contract Research Organization], CRO and laboratory portfolio management. Work closely with external operation team and is responsible for quality technical aspects drug product and analytical testing at CMO [Contract Manufacturing Organization] and CMO qualified lab. Under the guidance of the Director of Quality Assurance, provide technical expertise to the Quality group, and be the point person for the quality organization for supporting all commercial, clinical supply chain external quality operations and activities for finished goods manufacturing through final finished goods distribution. Oversee cGMP contract testing, including review and approval of analytical methods, method validations, specifications, qualification, and stability programs at CROs and CMOs. Ensure Quality Control related documentation (QC test methods, analytical validation and/or qualification, reference standard program, and stability studies) meet ICH [International Conference on Harmonization] and other regulatory guidelines. Represent Quality on project team and partner with Applied Research and Quality Control department to identify, develop, and implement specialized approaches, techniques, and technologies to study drug potency, impurity levels, elution rates, and local drug distribution. Manage cGMP stability programs for clinical and commercial products. Perform trend analysis and reporting on stability data for drug product. Act as SME for evaluation of analytical test data for In-process testing, Drug substance/drug product batch release and stability data. Ensure external laboratory LIRs [Laboratory Investigation Reports], change controls, OOS/OOT investigations are documented in QM [Quality Management System]. Analyze and interpret complex data sets efficiently and accurately, and make recommendations using professional judgment to impact drug development, API stability data, and regulatory requirements. Requires up to 15% travel (domestic).

[**Hybrid Remote permissible within MA.]

JOB REQUIREMENTS:

1. Bachelor’s degree or equivalent in Chemistry or related field, and 5 years of experience in job offered or as Analytical Scientist/Chemist, or related pharmaceutical QC/QA job.  Alternatively, will accept a Master’s degree or equivalent in Chemistry or related field, and 2 years of experience in job offered or as Analytical Scientist/Chemist, or related pharmaceutical QC/QA job.

2. Must have experience with:

• Pharmaceutical quality, GMP QA/QC compliance or laboratory experience;

• Pharmaceutical Industry standards and regulations (i.e. 21CFR 210/211, 820, ISO 13485);

• Clinical, commercial and multiproduct facilities;

• Analytical chemistry (QC and/or R&D).

• HPLC, FTIR, UV/vis and Dissolution/Drug Release;

• Analytical method validation ICH Q2, method transfer and managing stability programs;

• Acting as Analytical Chemistry SME and providing technical guidance to junior scientists and QC chemists.

3. Good written and oral communication skills.

4. Requires up to 15% domestic travel.