Senior GMP Analyst III

Senior GMP Analyst III

 

Cephalon is a place to think big.  It’s a work environment that challenges sharp minds, values an eye for opportunity and satisfies the motivation to make a positive impact.  The success of the company today reflects a collective ability to spot unexpected opportunities and the courage to waste no time in seizing them.  It’s a place where confidence is valued, independence is encouraged and agility is rewarded.

 

Position Summary

The Sr. GMP Analyst III will conduct or supervise Cephalon’s analytical testing activities for pre-clinical studies, clinical development, method transfer, process transfer, process improvement, scale-up and validation.  This is an experienced laboratory position requiring demonstrated application of standard principles, theories and techniques to solve specific problems.  This position is responsible for maintaining compliance with applicable ICH, GLP, GMP, DEA and safety regulations.  The Sr. GMP Analyst will also be responsible for preparing internal and external presentations and writing finished reports that are suitable for FDA submission.  The position requires some degree of independence, technical expertise, ability to perform complex work, and potential supervisory responsibilities.  There are some potential supervisory responsibilities that may include scheduling, planning resources, managing, motivating and evaluating subordinates.

 

Minimum Qualifications

 High School diploma with at least 15 years experience, or AAS Degree with at least 12 years experience, or BS Degree with at least 6 years experience, or MS Degree with at least 6 years experience, or PhD degree in a related field with 0-1 years relevant experienceExperience in the pharmaceutical industry with scientific expertise and working knowledge of technical aspects of pharmaceutical testing Knowledgeable in US government regulations (ICH, GLP, GMP, EPA, OSHA, DEA, etc) and the ability to train others in these regulations and implement these regulations in the workplace  Understanding of the drug development process and the process of methods development, validation, and methods transfer in addition to the commercial Quality Control process  Must be able to make independent decisions, recommendations, interpret available data, effectively communicate results and motivate internal and external quality control functions to operate effectively and efficientlyKnowledgeable in method validation, stability testing, process validation, quality assurance, and regulatory requirements.Possess a thorough knowledge and understanding of applicable scientific principles.Demonstrate effective leadership skills.Ability to work independently with internal and external groups on multiple projects.Good written and verbal communication skills with demonstrated ability to establish and maintain effective communications internally and with external analytical and manufacturing partnersBasic competency in use of business and project management computer software (such as MSProject and MSOffice) Capable of working variable/rotating shifts, holidays, weekend and hours outside or in addition to the normal scheduleCapable of transporting self to various work locations. If using own motor vehicle, must have current, valid US driver's license and proof of insurance coverage that at least meets current minimum requirements of the licensing state.



Physical Requirements

 

This laboratory job requires full use of sight, hearing and touch plus strength to lift heavy boxes of laboratory supplies and sufficient manual dexterity to perform fine manipulations.  In addition, this position requires the ability to ascend multi-floor internal and external staircases or ladders, to wear personal protective equipment such as respirators, to enter areas where equipment is in operation and occasionally produces objectionable noise, dust or fumes, and to comply with safety procedures of an operating environment such as responding appropriately to alarms.

 

 For immediate consideration, please apply to:  http://www.applyforjobsnow.com/afjn/jobboard/Redirect.aspx?__JobID=566