• Review departures from procedures and recommend action for approval by Manager. Approve GMP records.

• Lead the Investigation of Laboratory deviation, out of specification/trend (OOS/OOT) and initiate & implement CAPA.

• Develop and implement policies and procedures. Implement approved changes in collaboration with labs, production, regulatory, client and Quality.

• Draft submission ready sections of regulatory dossiers for drug products for approval by management. Draft specification rationales for drug products.

• Serve as the technical and regulatory expert. Back up to key regulatory inspection contact. Participate in negotiations with clients, regulatory reviewers and inspectors on issues to assure timely resolution of issues or approval of client applications.

TRAVEL:

Up to 5% domestic and international travel required. Can work remotely or telecommute.

REQUIREMENTS:

MINIMUM Education Requirement: Bachelor's degree or foreign degree equivalent in Chemistry, Biology or a related field of study.

MINIMUM Experience Requirement: 6 years of experience as a Scientist or in lab project management, validation role, or related experience.

Alternative Education and Experience Requirement: The employer will alternatively accept a Master's degree or foreign degree equivalent in Chemistry, Biology or a related field of study plus four (4) years of experience as a Scientist or in lab project management, validation role or related experience.

Required knowledge or experience with:

• OOS/OOT investigations Chromatography Experience (HPLC), UV, GC;

• DEA controlled samples, highly potent compounds and cytotoxic drugs;

• Deviation, CAPA implementation, change controls;

• Analytical method evaluation, development, validation and verification for drug product and raw materials for assay, impurity, content uniformity, residual solvent, equipment cleaning verification, identification test;

• Chromatography experience (HPLC), Gas Chromatography (GC), atomic absorption spectroscopy, dissolution, FT-IR, UV, disintegration, hardness, thickness, Karl Fisher Titration, and Container Closure Integrity test (CCIT);

• Stability: data trending for formulation development samples, interpretation of analytical test results;

• Routine testing for raw material, finished product, stability in process sample in compliance with GMP guidelines;

• GMP documentation practices;

• Analytical technical project management project in CROs and CDMOs;

• FDA deficiencies responses;

• Analytical techniques for large molecules or proteins.