Associate Director, Analytical R&D/AR&D

Catalent Pharma Solutions•Winchester, KY

About The Position

Develop, implement and communicate a clear strategic vision for quality control to maximize employee focus and develop a competitive advantage. Maintain the highest degree of product quality and quality control systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems. Ensure Quality Control systems are compliant with current FDA, ICH, USP, EP, JP, MHRA, corporate and site procedures as well as industry standards including but not limited to analytical method validations OOS/OOT investigations and root cause analysis, corrective and preventative actions (CAPA), and training. Manage the Quality Control team. Participate in the site Quality Management Review. Oversee analytical investigations and root cause analysis. Oversee the Analytical R&D team for method development, transfers and validations processes to support the introduction of new product pipelines to the site. Facilitate receipt and release processes for the cleaning verifications samples, raw materials, in process samples and finished products. Oversee the laboratory instrument IQ/OQ and calibration program. Ensure the Change control process including, but not limited to, analytical methods, raw material, in process and finished product specifications, comply with site SOPs. Responsible for the Quality Control department strategic growth plan. Oversee the laboratory stability testing program. Ensure analytical laboratory software platforms meet CFR Part 11 and the current regulatory data integrity requirements and the respective corporate policy. Develop and/or administer and maintain the employee training program. Enforce cGMP compliance through the department training program. Ensure Quality Control department follow site DEA SOPs when handling control substances. Oversee proper documentation related to employee performance and timekeeping records, administer employee discipline as appropriate and in coordination with Human Resources. Ensure Quality Control programs including CAPA, Quality Management Review and deviation investigations, raw material and finished product specifications, ComplianceWire, and the Employee Training Program remain current to achieve regulation satisfactions. Participate in FDA and other regulatory agency inspections and customer audits as required. Ensure the adherence to the standards of quality ruled by current cGMPs and the Company’s Quality Policies and the site Standard Operating Procedures. Propose, implement and enforce quality improvements.

Requirements

Requires a Bachelor’s degree in Chemistry or Related Field and 8 years of experience in job offered or 8 years of experience in the Related Occupation.
Executing analytical method validations, compendial verifications, USP Vs In-house method equivalency studies, method transfers activities according to the site procedures in compliance with ICH, FDA and other regulatory guidances and current industry standards to avoid major analytical related regulatory deficiencies to ensure drug product approvals in first cycle review. Method development and validation of cleaning verification samples and managing stability studies as per ICH Q1 requirements.
Evaluating USP methods and finalizing the analytical methodologies by modifying them to suit in-house conditions within the allowable limits of USP<621>.
Handling the OOS/OOT/deviations/atypical results as per company’s procedures and in compliance with regulatory requirements to find out the root cause and implementing appropriate CAPAs.
Scheduling and managing IQ/OQ/PQ activities.
Handling the receipt and release of cleaning verification samples, raw materials, in-process and finished products as per the company’s procedures.
Writing/reviewing SOPs, test procedures, other technical documents as needed, justification of specification and COA’s for release purpose of API’s, excipients, packaging components and stability compilation of finished products in compliance with cGMPs.
Partnering with formulation, quality, regulatory and other departments as needed to propose and implement quality improvements. Participating in FDA and other regulatory agencies inspections as needed.
Ensuring compliance with company’s SOPs. Handling of DEA scheduled drugs as per site DEA SOPs. Ensuring adherence to the CFR part 11 and current regulatory data integrity requirements.
Working with formulation scientists and performing Pre-formulation/excipient compatibility studies to finalize the formulation and manufacturing process optimization as needed. Updating analytical sections/quality overall summary etc. to assist with regulatory dossier submissions and prepared responses for Information requests (IRs) /Complete Response letters (CRLs) from FDA.

Responsibilities

Develop, implement and communicate a clear strategic vision for quality control to maximize employee focus and develop a competitive advantage.
Maintain the highest degree of product quality and quality control systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems.
Ensure Quality Control systems are compliant with current FDA, ICH, USP, EP, JP, MHRA, corporate and site procedures as well as industry standards including but not limited to analytical method validations OOS/OOT investigations and root cause analysis, corrective and preventative actions (CAPA), and training.
Manage the Quality Control team.
Participate in the site Quality Management Review.
Oversee analytical investigations and root cause analysis.
Oversee the Analytical R&D team for method development, transfers and validations processes to support the introduction of new product pipelines to the site.
Facilitate receipt and release processes for the cleaning verifications samples, raw materials, in process samples and finished products.
Oversee the laboratory instrument IQ/OQ and calibration program.
Ensure the Change control process including, but not limited to, analytical methods, raw material, in process and finished product specifications, comply with site SOPs.
Responsible for the Quality Control department strategic growth plan.
Oversee the laboratory stability testing program.
Ensure analytical laboratory software platforms meet CFR Part 11 and the current regulatory data integrity requirements and the respective corporate policy.
Develop and/or administer and maintain the employee training program.
Enforce cGMP compliance through the department training program.
Ensure Quality Control department follow site DEA SOPs when handling control substances.
Oversee proper documentation related to employee performance and timekeeping records, administer employee discipline as appropriate and in coordination with Human Resources.
Ensure Quality Control programs including CAPA, Quality Management Review and deviation investigations, raw material and finished product specifications, ComplianceWire, and the Employee Training Program remain current to achieve regulation satisfactions.
Participate in FDA and other regulatory agency inspections and customer audits as required.
Ensure the adherence to the standards of quality ruled by current cGMPs and the Company’s Quality Policies and the site Standard Operating Procedures.
Propose, implement and enforce quality improvements.