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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

Electrician 3rd Shift Job - Exton, PA

Exton PA

• High School Diploma required, Associates Degree or equivalent experience preferred. • A minimum of 4 years working experience in a cGMP Facilities department in a FDA regulated industry with a Associates Degree or a minimum of 6 years working experience or technical degree or higher from an accredited college or university or certifications in one or more of the following technical fields (e.g. electrical/electronic;) and at least 4-6 years of experience in general maintenance or other maintenance responsibilities that would include the ability to recognize electrical, and mechanical malfunctions, or equipment failures. Biotech or pharmaceutical experience preferred. • Ability to recognize, assess and troubleshoot electrical and mechanical malfunctions, or equipment failures required. Ability to make minor electrical repairs to buildings and equipment and independently manage major repairs by an outside contractor. • Must have excellent interpersonal and communication skills. Must be able to deal tactfully and courteously with fellow employees and venders/contractors. • Thorough knowledge of the occupational hazards and corresponding safety precautions necessary for safe performance in using equipment to complete assigned tasks. • Must be familiar with compliance requirements (cGMP, GLP, OSHA, CFR, etc.) • Must be able to operate independently and recognize problem situations, inform his/her supervisor in a timely manner and address these problems in a timely manner so that the facility remains operational. • Must possess the ability to exercise sound judgment and decision-making, effectively plan and organize multiple tasks with high degree of complexity in order to complete them efficiently and in a timely manner. • Prior experience in a GMP plant and experience with 21 CFR part 11 is required. • Knowledge of cGMP regulations • Experience with CMMS Software • Working knowledge of Microsoft operating systems is required • Proficient in MS Office applications • Ability to prioritize and successfully manage complex and competing projects • Strong problem solving and reasoning skills • Ability to respond with troubleshooting methods under time and delivery pressure. • Ability to maintain control in stressful situations, and perform well under pressure.

Posted On - 5/28/2014 9:18:45 AM

HVAC Maintenance Mechanic-3rd Shift Job - Exton, PA

Exton PA

• High School Diploma, Preferred Associates Degree or equivalent military experience. • Minimum level of education and years of relevant work experience, • Special knowledge of skills needed and/or license or certificates required, • Physical requirements. • A minimum of 5 years work experience in a cGMP facility department in a FDA-regulated industry w/an Associate’s Degree, or a minimum of 7 years working experience in a GMP Facilities department. • Experience with inspections/audits by the FDA or other similar regulatory agencies. • Experience with CMMS Software. • Working knowledge of Microsoft operating systems is required. • Proficient in MS Office applications. • Ability to prioritize and successfully manage complex and competing projects. • Strong problem solving and reasoning skills. • Ability to respond with troubleshooting methods under time and delivery pressure. • Ability to maintain control in stressful situations, and perform well under pressure. • Effective interpersonal, written and oral communication skills.

Posted On - 5/28/2014 9:17:23 AM

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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