Head of Drug Product Analytical Operations

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide) the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide a next-generation long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases including short bowel syndrome with intestinal failure as well as several earlier stage assets. Building upon our history of GI innovation we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.

The Director Head of Drug Product Analytical Operations leads analytical development and lifecycle support for drug products peptide-based products medical devices combination products and related packaging within CMC activities. The role provides strategic and technical leadership across Technical Operations Quality Regulatory CMC and external partners to support developmenttechnical transfers process validationregulatory submissions clinicalbulksupplyreadiness commercial preparedness and lifecycle management. This position oversees outsourced analytical programs drives risk-based decisions ensures compliance with global regulatory standards and leads teams to foster collaboration and operational excellence.

Essential Functions

Leadership and Team Development:

- Lead and develop the Analytical Drug Product team fostering excellence collaboration innovation and continuous improvement.

Outsourced Analytical Management:

- Oversee outsourced analytical development at CROs/CDMOs ensuring phase-appropriate strategy quality governance and alignment with project priorities.

- Build external partnerships and review key technical documents to support compliant execution issue escalation and lifecycle changes.

Drug Product Medical Device and Combination Product Development within CMC Activities:

- Lead analytical strategy for drug products devices and combination products including methods characterization stability extractables andleachables and peptide-specific support.

- Oversee impurity degradation release stability comparability and compatibility assessments critical to development and lifecycle management.

- Partner with CMCandproduct teams to support developmentregulatorysubmissions clinicalbulksupplyincluding release and stability and lifecycle plans.

- Ensure stability programs meet global expectations and support shelf life product quality and compliance.

Regulatory Support:

- Prepare and review analytical content for global regulatory submissions covering drug products packaging and combination products.

- Serve asan analyticallead for health authority interactions ensuring compliant methods data specifications and lifecycle support.

- Lead responses to agency questions inspections and audits with sound analytical justification.

Primary and Secondary Packaging:

- Oversee analytical evaluation of primary and secondary packaging including integrity extractables andleachables and compatibility testing.

- Ensure packaging studies are integrated into stability and lifecycle programs

Cross-Functional Collaboration:

- Partner across Technical OperationsClinical Supply Manufacturing Supply ChainQuality Regulatory CMCand program teams to integrate analytical support.

- Provide analytical leadership in governance technical transfer issue resolution and risk-based decision-making across external sites and product teams.

Budget and Resource Management:

- ManageAnalyticalbudgetsfor Drugproductcombinationproductand resources effectively including oversight of externalspendingand cost optimization.

Project Management:

- Lead multiple analytical activities ensuring prioritizationtimelyexecution budget control and alignment with programobjectives.

-Identifyand mitigate risks lead troubleshooting and investigations and communicate recommendations to senior management.

- Stay current on analytical packaging and regulatorytopicsand apply best practices to strengthen capabilities.

- Drive continuous improvement across outsourced and internal operations and bring external innovation into the organization.

Requirements:

- Education:

Ph.D. in Analytical Chemistry Pharmaceutical Sciences Chemistry or related discipline with 10 years of pharma/biotech industry experience; orMastersdegree with 15 years of relevant industry experience.

- Experience:

- Extensive analytical development experience with combination products including injectable drug product support packaging lifecycle development Phase 3 process validation launch readiness and commercial transfer.

- Experience supporting injectable synthetic peptide drug products including characterization orthogonal methods bioassays solid-state characterization stability and phase-appropriate analytical strategies.

- Proven success managing outsourced analytical activities with global CROs/CDMOs across complex development programs.

- Extensive experience with method development qualification validation transfer comparability and regulatory submissions for drug products devices and combination products.

- Experience with packaging assessments including extractables andleachables compatibility evaluations and related analytical studies.

- Familiarity with ICH FDA EMA JP and relevant ISO standards including support for health authority interactions and phase-appropriate development.

- Skills:

- Strong project management and organizational skills with the ability to manage complex initiatives and prioritize effectively in a matrix environment.

- Strong problem-solving skills especially in troubleshooting analytical challenges for drug products devices combination products and packaging.

- Effective communication and collaboration skills with the ability to influence cross-functional teams and external partners in a global environment.

-Proficiencyin data analysis and interpretation translating findings into clear technical regulatory and business recommendations.

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.

Ironwood currently anticipates that the initial base salary for this position could range from between $214000- $249795. The actual base salary will depend in part on the successful candidates qualifications for the role including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical dental vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.

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