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Key skills for this role
PhD in Analytical Chemistry, Biochemistry, Biology or a related scientific field
10+ years Quality Control experience is required, preferably with both biologics and small molecules
Strong knowledge of GMPs, ICH guidelines and Quality management systems
Experience with analytical methods technology transfer to third parties
Experience with regulatory authority meetings and GMP site inspections
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Extensive experience with analytical method development and validation
Expertise with stability testing, data trending and expiry setting strategy
Experience with testing injectable and oral dosage forms preferred
Experience in big pharma/biotech; experience in a startup biopharma company is desirable
Proficiency in MS Office, Word and Excel; statistical analysis software is desirable
Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and externally with third party contract organizations
Excellent written and oral communication skills with a proven track record of developing employees
Self-motivated and detail-oriented, with the highest integrity
Verified company details for this employer are not available yet.
USD 210000-245000 yearly / year
Full-time
Senior · 10+ years experience
Onsite
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