Quality control manager

Quality Control Manager

Our client is looking for a Quality Control Manager with experience in small molecules, validation, analytical chemistry, methods validations, etc. Manage small molecules/oral solid dosage analytical test methods validations and transfers for release and stability testing of commercial pharmaceutical products. Manage complex scientific knowledge of analytical methods and updates. Manage a staff of qualified scientific employees and provide guidance in the area of expertise.

Responsibilities:

• Method design (re-design) and validation (re-validation)

• Method performance monitoring (trending), control and troubleshooting

• Methods transfer working with internal and contract sites

• Author analytical regulatory sections and response to questions

• Work with interconnected departments and other groups in Pharmaceutical Operations

• Analytical expert for assay optimization, validation and transfer

• Present analytical issues and findings to senior management

Qualifications and skills needed:

• A bachelor's degree in analytical chemistry with 5+ years or a Master's with 3+ years of leadership and experience in a pharmaceutical/biotechnology industry.

• Experience directing activities related to analytical method development, qualification and validation of small molecules, oral solid dosage assays, method performance monitoring, methods transfer and working with external laboratories.

• Experience with regulatory writing of analytical sections and response to questions

• Excellent communicator, author and creative thinker with extensive knowledge in the area of expertise

• Specific techniques include chromatography, particle size, XRPD, Dissolution and Disintegration, ICP-MS, KF and compendia methods

• Excellent project and people manager who can motivate, direct projects, and align scientific