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Vice President CMC Operations - Gavelston, TX

Kelly Services
Galveston, TX 77551
Kelly Government Solutions is currently recruiting for a Vice-President of CMC (Chemistry, Manufacturing and Controls) Operations for a Bio-pharmaceutical company in Galveston, TX.



This position is Direct Hire and offers:




+ Competitive salary with comprehensive benefit package





**RESPONSIBILITIES** :






+ Responsible for oversight and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacturing and supply of Drug Substance (API) and Drug Product (DP).







+ Formulation design/development for clinical programs







+ Direct efforts to implement stage appropriate analytical methods and protocols to ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards







+ Execute plans for validation, registration of API required by cGMP, ICH and FDA regulations including writing and reviewing documents for IND










+ Performs other miscellaneous assignments and projects as assigned







+ Adheres to company and department policies, procedures, and standards







+ Supports, cooperates with, and participates in Employee Health and Safety(EHS) Management System which includes following all safety, health and environmental policies and procedures. Supports and cooperates in Quality Management policies and procedures.





**REQUIREMENTS** :




+ PhD or MS with 8-10 years experience in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related discipline

+ Experience in managing US and International CRO/CMOs for the manufacture of cGMP APIs and DP

+ Experience with and knowledge of formulation development processes




+ Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others




+ Highly organized, with ability to prioritize and work under pressure

+ Ability and willingness to work within a team environment in support of company objectives.



**If interested and qualified, please apply online** .



Any inquiries, please email recruiter at delcolj@kellyservices.com.








**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-08-12 Expires: 2019-09-14

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Vice President CMC Operations - Gavelston, TX

Kelly Services
Galveston, TX 77551

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