Quality control manager

Our Client is looking for Quality Control Manager-with Small molecules, validation, analytical chemistry, methods validations etc. experience…..!!!!!

Summary: 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

Regards

Pooja Mishra

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

Tel: 732 429 1636

(W) 732-549-2030 x 214 | (F) 732-549-5549

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