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Career Openings


Sr. Director, Analytical Development

ID: 1445
Department: Analytical Development
Location: Cambridge Headquarters
# of Openings: 1

Description

Functional area: Analytical Development

 

We are focused on discovering and transforming knowledge into medicines that make a difference for patients’ lives. We have a robust clinical pipeline investigating treatments for gastrointestinal, vascular and fibrotic diseases using new chemical entities and drug delivery technologies. Today we have treated over one million patients with LINZESS®, our first commercial product for irritable bowel syndrome and chronic idiopathic constipation. ZURAMPIC® and DUZALLO® were recently launched for the treatment of gout.

 

Position description:

The Senior Director will lead the Analytical Development function and oversee analytical program activities for drug substance and drug product from candidate nomination to commercialization. The successful candidate will be a core member of leadership teams that drive CMC strategy and Pharmaceutical Development operations. The position will report to the VP Pharmaceutical Development.

 

Responsibilities:

  • Phase appropriate analytical method development and validation for small molecules and synthetic peptides, immediate release and modified release solid oral dosage forms, including solubilization technologies.

  • Drive innovative approaches to the development, evaluation, and negotiation with regulatory agencies of analytical control strategies including specifications and stability.

  • Establishment and management of associated reference standards and reference materials.

  • Development of Module 3 analytical content in collaboration with Regulatory Affairs CMC, serving as the analytical lead for associated regulatory interactions.

  • Development of phase appropriate, risk-based quality systems in collaboration with Quality.

  • Adopting and driving innovative analytical techniques and strategies that translate into robust commercial analytical testing platforms.

  • Recruit, develop, and mentor the analytical team to meet current and future program, department, and individual goals.

  • Champion ownership through excellent cost-center management.

 

Qualifications:

  • Deep experience leading an Analytical Development function with GMP responsibilities.

  • Proven success with US and international regulatory approvals.

  • Demonstration of driving analytical innovation.

  • Ph.D. in analytical chemistry or related subject with over 15 years industrial experience.


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





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