ANALYTICAL DEVELOPMENT PROFESSIONALS

ANALYTICAL DEVELOPMENT PROFESSIONALS 

 

 

Leading Pharmaceutical and Biotechnology companies are seeking experienced Analytical Development professionals. These rapidly growing companies are seeking experienced candidates with proven skills. The following positions are available:

 

DIRECTOR, ANALYTICAL R&D- This person will direct the activity of 20+ scientists responsible for the development of analytical methods in support of the CMC section of the NDA.  Additional departmental responsibilities include, but are not limited to, the determination of novel raw materials or excipients in formulated drug products, qualifying or validating the aforementioned methods, performing cGMP compliant release tests for excipients in formulated drug products, supporting investigations associated with the manufacture of cGMP drug substances and drug products. The ideal candidate will have a Ph.D. in Analytical Chemistry or related field with 7 years of experience or a BS/MS in Chemistry with over 12 years of industrial experience. This person must have proven leadership experience.

 

PRINCIPLE SCIENTIST, ANALYTICAL R&D- The successful candidate will be responsible for developing and validating analytical methods (HPLC, GC, AA, UV-VIS and Karl Fisher). This person must have experience developing methods for raw materials, in process and finished product testing. Responsibilities include supporting QA/ Regulatory affairs by assembling methodology, and data for submission of regulatory documents and FDA investigations with minimal oversight from department management. Requirements: Ph.D. with 4 years of experience or BS/MS with 6+ years of analytical method development experience. Experience working with a variety of dosage forms is a plus (solids, semi-solids etc). CMC documentation experience is a plus.

 

SENIOR SCIENTIST- Responsible for developing and validating analytical methods (HPLC, GC, UV-VIS and Karl Fisher). Must have experience characterizing impurities in drug substances. Familiarity with FDA filings is a plus (NDA, CMC). The successful candidate will have a PhD with 1+ year or BS/MS with 3+ years of experience. This individual will be expected to coordinate the activities of a small group of scientists.  This scientist must have proven oral and written skills and will be expected to write and review technical documentation. Furthermore, experience with LC/MS/MS is a plus.



 

SUPERVISOR, ANALYTICAL METHOD DEVELOPMENT- Responsibilities include leading a team of chemists in the development and validation of analytical methods for drug products ranging from Phase 1 through Phase 3 of the pharmaceutical development process. This individual will provide chemistry support to formulation and product development. Responsibilities include special studies, preparing technical reports and making presentations.
Requirements: 7+ years of experience in the pharmaceutical industry developing and validating analytical methods; a BS/MS/PHD degree in chemistry or a related technical field. Excellent written and verbal communications skills are a must!

 

 

 

The positions are located in the following areas: Pennsylvania, Minnesota, Ohio, New Jersey, Texas, Florida and Massachusetts. Relocation assistance will be provided.