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Company Jobs - Morphotek®, Inc.

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Charles @ Morphotek®, Inc.


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Sr. QA Specialist, CMO Support

Exton NJ

• 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 - 11/5/2014 8:36:44 AM

Process Engineer, Upstream Operations

Exton PA

BS, MS or PhD in chemical engineering or other engineering Experience: Minimum of 7 yrs (BS), 5 yrs (MS), or 3 yrs (PhD) practical scientific experience Minimum of 3-7 yrs in a multi-discipline cGMP environment, commissioning and running equipment in upstream production areas. Knowledgeable in mammalian cell culture, upstream equipment operation, and CIP/SIP operations. Knowledgeable in technology transfer, equipment validation and facility startup. Ability to identify, investigate, and solve process and equipment problems. Strong working knowledge of cGMP, EMEA, and JP regulations. Excellent written and communication skills. Excellent interpersonal skills. Team player who can excel in a “hands-on” entrepreneurial environment

Posted On - 11/5/2014 8:34:25 AM

Program Manager, Biologics (Protein Therapeutics)

Exton PA

• Provide technical and regulatory support and lend expertise to other late stage molecules • Provide technical oversight to the programs they manage through a strong knowledge of biologics manufacturing and cGMP, FDA, EU and JP guidelines • Ensure that programs remain on schedule. Identify major milestones and critical steps. Ensure communication between team members within Eisai-PST and Eisai-PCUs and keep senior management abreast of progress, potential impediments and solutions • Participate in budgeting, financial tracking and financial decision making for CMC drug development programs •Develop and then manage project management systems for the Eisai Pilot Plant Job Qualifications • 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 - 11/5/2014 8:28:57 AM

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