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Career Openings


Associate Director, Analytical Development

ID: 651
Department: CMC Pharmaceutical Development
Location: HQ: Cambridge
# of Openings: 1

Description

Functional area:

Analytical Development

 

Position description:

The Analytical Development group at Ironwood Pharmaceuticals is searching for an Associate Director with outstanding technical and managerial capabilities to drive forward our exciting pipeline of development-stage programs. In addition to providing deep expertise in method development, the successful candidate will lead analytical activities for projects in various stages of clinical development, helping our GI and CV franchises to bring innovative new therapies to patients. Other leadership responsibilities include assuring adherence to phase-appropriate regulatory and quality requirements, and serving as mentor and supervisor to other group members. This position reports to the Director, Analytical Development

 

Responsibilities:

  • Develop and implement analytical methods for release and stability testing for drug substance and drug product;

  • Transfer analytical methods to external laboratories, and oversee phase-appropriate validation, testing, and data receipt;

  • Manage formal and informal stability studies, apply statistical methods of analysis, and guide project team activities based on stability outcomes;

  • Establish phase-appropriate specifications and control strategies for materials, design studies to support late-phase specification development, and author justification of specification documents;

  • Author methods, operating procedures, protocols, analytical development reports, and the analytical sections of regulatory filings;

  • Lead analytical activities for programs at all stages of development, and represent the Analytical Development function on project CMC teams;

  • Collaborate effectively with the Chemical Development, Formulation Development, Quality, and Regulatory groups to meet program goals;

  • Serve as direct supervisor to Associates and Scientists within the group, providing technical mentorship and attending to long-term skills development.

 

Basic qualifications:

  • Ph.D. in chemistry or related scientific discipline;

  • 8 years of relevant analytical experience in the pharmaceutical industry, including direct experience with oral drug products;

  • Deep practical experience in separation techniques and detection methods, including reverse phase, normal phase, ion exchange, and size-exclusion chromatography;

  • A well-grounded foundation in other analytical techniques such as MS, NMR, UV and IR spectroscopy, with strong understanding of the underlying principles;

  • Strong oral and written communication skills, with experience in preparing protocols, technical reports, and regulatory filings;

  • Broad knowledge of regulatory and compendial guidance (GMP, GLP, ICH, USP) and practical experience in meeting requirements in a phase-appropriate manner;

  • Proven track record in leading analytical development activities in various stages of development;

  • Extensive experience working internally with multidisciplinary teams, and externally with contract research organizations and contract manufacturers;

  • Proficiency in managing and mentoring analysts, including career development and performance assessment;

  • Ability to contribute leadership, independent judgement, and an enthusiastic attitude to our fast-paced and dynamic environment.

 

Preferred qualifications:

  • Practical  knowledge JMP and Empower software;

  • Familiarity with methods for physicochemical characterization (XRPD, DSC, TGA).

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.





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You are now leaving ironwoodpharma.com. This link will take you to
a website to which our privacy policy does not apply. You are solely
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