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

Careers Integrated Resources Inc