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Analytical Development and Quality Control Consultant

Analytical Development and Quality Control Professional
The Analytical Development & QC professional will be a contract member of the analytical method development team, supporting activities associated with development of the tests and procedures that will eventually be used for quality control of Company's APIs and drug products.
ESSENTIAL DUTIES:

  • Contribute to guidance of CTLs and CMOs who on the company's behalf analyze food allergens to determine how potent / allergenic they are.

  • Use testing information to support manufacturing of oral immunotherapy (allergy desensitization) products. Contribute to the interpretation of QC product release and stability data.

  • Develop and validate analytical methods with CTL's and CMO's for the potency, purity, and content of the products. Assays may include HPLC, ELISA, and other methods.

  • Participate in establishment / revision of drug substance and drug product specifications for IND, IMPD, and BLA submissions using statistical analysis and other approaches.

  • Act as the subject matter expert for investigation and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results.

  • Author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA).


QUALIFICATIONS/REQUIREMENTS
Education and/or experience:

  • Advanced degree (Ph.D. or MS) in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 3 years relevant experience in a pharmaceutical cGMP environment, or BS with at least 5 years of experience.

  • Excellent written and verbal communication skills. Technical writing for IND and regulatory submissions is desirable.

  • Expertise in use of Excel or comparable software solutions for management and analysis of data. Experience with JMP and/or Minitab is desirable.

  • Accuracy and attention to detail.

  • Excellent cross-functional team participation skills.

  • Outstanding problem solving abilities.

  • Ability to effectively prioritize and deliver on tight timelines.





Company Description:

About Ascent:


Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.


If you are ready to propel your career to new heights… read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.




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