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Analytical Chemistry
Endocyte
West Lafayette

Date:  7/1/2010
Position Type:  Full Time

Start Date:  Immediate Availability

Duties/Responsibilities:

Endocyte is a privately held biotechnology company headquartered in the Purdue Research Park in West Lafayette, Ind. We are currently seeking a Analytical Chemistry to join our team!

The qualified candidate will provide leadership for the analytical team and direct analytical activities related to method development from lead identification through NDA approval.  This position will provide oversight of analysis and characterization of new clinical candidates, method development, stability testing, preparation of reference standards and certificates of analysis, drug metabolite analysis and directly assist in the outsourcing of method validation, in the preparation of CMC regulatory submissions, and in the support of the discovery chemistry program.  Defines efficient procedures for analytical method development within Endocyte and technology transfer from Endocyte to contract lab and contract manufacturing partners.

• Composes the Analytical CMC section of regulatory filings for new and existing products;conduct potential gap analysis on analytical methods, specifications, stability data (that would be used to support the storage conditions of the reference standards) etc.
• Provides technical leadership to the reference standard group, stability team, characterization effort and Discovery chemistry; e.g., scientific rationale to identify analytical tests that are necessary to conduct full characterization of a primary reference standard, sets  up expiration/re-evaluation dates for working and primary reference standards etc.
• Performs analytical chemistry research to support new and existing methodologies.
• Oversees the outsourcing and validation of test methods used to control raw materials, production intermediates, and final products.
• Conducts testing of analytical samples for the laboratory area, support formulation development, and other analytical methods of development.
• Conducts work in compliance with cGMP, safety and regulatory requirements during product development, clinical batch production and commercial processing of API and drug product. 
• Provides analysis and evaluation of material and products at all stages of development process.
• Oversight of the Stability Program.
• Monitor and evaluate the completion of projects and tasks within the analytical team.

Requirements/Qualifications:

•  Ph.D. in Analytical Chemistry or in Pharmaceutical Sciences, preferably with core expertise/experience in Analytical Chemistry/Separation Sciences area. 
•  At least 8+ years of relevant experience (in Analytical Chemistry) in pharmaceutical industry.  
• Five or more years experience in managing and leading a group that is involved with routine and non-routine analytical activities such as problem solving, trouble shooting, identification of unknown chromatographic, peaks in samples, etc., is a plus.  
• Proven track record in the development and implementation of new and rugged analytical methods. 
• Broad knowledge and/or experience on analytical techniques such as LC-MS, HPLC, UPLC and MS is essential.  
• Strong knowledge and experience on cGMP and regulatory guidelines (FDA, ICH, etc.) pertinent to the analytical CMC section of an IND and NDA is required.  
• Must have a proven track record of scientific achievements.  
• Experience in leading and managing complex projects. 
• Must possess excellent oral and written communication skills.  
• Must be a strong leader and a team player with proven track record in leading and influencing others.
• Proficient understanding of the influence of cGMP and regulatory requirements in the drug development process.

Company Description:

Endocyte values our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation annually and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.

 

Application Instructions:

Send resume to jobs@endocyte.com  mail:  Endocyte Inc.  Attn: Human Resources 3000 Kent Avenue  A-1 100 West Lafayette, IN 47906 

Fax:  765-463-4621. 

URL: www.Endocyte.com