Open Positions

Position Description:

 

The Senior/Principal Analytical Scientist will be responsible for performing, supporting, and overseeing multiple aspects of analytical development for drug substance and drug product. This position is responsible for performing analytical method development and any related analytical support for drug substance, drug product, manufacturing, stability, regulatory submissions, and vendor management.

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Roles and Responsibilities:

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• Performs in-house internal analytical activities including method development for drug substance and drug product using techniques such as HPLC, LCMS, Karl Fisher, dissolution, particle size analysis, solid state characterization, IR, and GC.

• Provides analytical oversight of external vendors/partners for preclinical and clinical CMC activities for small molecule drug substance and drug product.

• Trouble-shoots internally any analytical issues for activities related to method development, stability and other related scope of work arising at contract manufacturing organizations (CMOs).

• Responsible for technological transfer of in-house analytical methods and corresponding phase appropriate method development and validation at CMOs.

• Provides key analytical input on different projects in periodic internal project meetings and routine vendor calls.

• Participates in the development and revision of product specifications; provides scientific input and critique while designing the specifications.

• Supports the Formulation Lead closely by discussing and designing the stability plan to be executed at the CMOs. Reviews the quality control testing of clinical trial supplies for release and stability performed at CMOs. Monitors the stability tracker and the subsequent analysis of data at designated pull points.

• Drafts and reviews the analytical portions of the CMC sections of regulatory submissions along with other functional groups. Participates in preparation of any responses to regulatory agency questions and ensures overall compliance with analytical requirements for CMC regulatory submissions.

• Leads the effort in routine maintenance and troubleshooting of internal analytical equipment.

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Qualifications:

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• MS/PhD in Pharmaceutical Sciences, Analytical Chemistry, Pharmaceutical Chemistry or Chemical Engineering with 3/5+ years laboratory experience, or equivalent.

• Demonstrated hands-on experience in routine analytical techniques for HPLC, LCMS, Karl Fisher, dissolution, particle size analysis, solid state characterization, IR, and GC.

• Sufficient working knowledge of ICH guidelines pertaining to cGMP, technology transfers, method development and validation. 

• Prior experience of managing routine analytical activities at CMOs is a plus but not required.

• Proven track record of teamwork, scientific excellence, clear communication, and attention to detail.

• Excellent interpersonal skills and history of establishing good relationships and contributing to a supportive team environment.

• Results oriented with excellent decision-making skills.