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Company Jobs - Morphotek®, Inc.

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Charles @ Morphotek®, Inc.


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Sr Program Manager, Biologics (Protein Therapeutics) Job - Exton, PA

Exton PA

• B.S. degree in biological or related science with an advanced degree such as an M.S., Ph.D. or MBA highly preferred. • Minimum of 5 years of biologics manufacturing experience with direct experience directing external manufacturing collaborations highly preferred. • Knowledge of analytical methods / cell based potency assays a plus • Strong knowledge of biologics manufacturing and FDA, EU and JP CMC regulations • Prior experience with manufacturing from pre-IND through phase 3 or commercial production. • Experience managing substantial budgets and leading diverse and international multidisciplinary teams. • Experience building and then managing project management systems to support biologics manufacturing. • Possess a hands-on proactive stance with excellent interpersonal skills and a willingness and ability to assist all team members to achieve the project goals • In addition to analytical problem solving skills, the ability to set priorities and achieve goals; strategic thinking, energy, enthusiasm and an entrepreneurial mindset

Posted On - 6/24/2014 3:11:59 PM

Sr. QA Specialist, CMO Support Job - Exton, PA

Exton PA

• B.S./B.A. in Science related field (or equivalent) • Minimum 3 years of drug/biotech experience • Minimum 3 years of quality auditing in GLP, GMP and/or ICH/GCP environment • Experience with Contact Manufacturing Organizations (CMO) relating to packaging/labeling of clinical trial materials preferred • Knowledge and experience with all aspects of Quality System Management, lot disposition, deviation and investigations, CMC participation, training, and auditing • Thorough working knowledge of regulated GMP systems

Posted On - 5/28/2014 9:12:21 AM

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