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About the role
<p> </p>
<p>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. </p>
<p><span lang="EN-US" data-contrast="none"><span data-ccp-parastyle="heading 1">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 development, </span><span data-ccp-parastyle="heading 1">technical transfers</span><span data-ccp-parastyle="heading 1">, process validation, </span><span data-ccp-parastyle="heading 1">regulatory submissions, clinical </span><span data-ccp-parastyle="heading 1">bulk </span><span data-ccp-parastyle="heading 1">supply</span><span data-ccp-parastyle="heading 1"> readiness, 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.</span></span><span data-ccp-props="{"134245418":true,"335559738":240,"335559739":160,"335572079":2,"335572080":6,"335572081":8421504,"469789806":"single"}"> </span></p>
<p><strong><span data-contrast="none"><span data-ccp-parastyle="Body Text">Essential Functions</span></span></strong><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">Leadership and Team Development:</span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Lead and develop the Analytical Drug Product team, fostering excellence, collaboration, innovation, and continuous improvement.</span></span><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">Outsourced Analytical Management:</span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Oversee outsourced analytical development at CROs/CDMOs, ensuring phase-appropriate strategy, quality, governance, and alignment with project priorities.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Build external partnerships and review key technical documents to support compliant execution, issue escalation, and lifecycle changes.</span></span><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">Drug Product, Medical Device, and Combination Product Development within CMC Activities:</span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Lead analytical strategy for drug products, devices, and combination products, including methods, characterization, stability, extractables and </span><span data-ccp-parastyle="Body Text">leachables</span><span data-ccp-parastyle="Body Text">, and peptide-specific support.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Oversee impurity, degradation, release, stability, comparability, and compatibility assessments critical to development and lifecycle management.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Partner with CMC </span><span data-ccp-parastyle="Body Text">and </span><span data-ccp-parastyle="Body Text">product teams to support development, </span><span data-ccp-parastyle="Body Text">regulatory</span><span data-ccp-parastyle="Body Text"> submissions, clinical </span><span data-ccp-parastyle="Body Text">bulk </span><span data-ccp-parastyle="Body Text">supply</span><span data-ccp-parastyle="Body Text"> including release and stability</span><span data-ccp-parastyle="Body Text">, and lifecycle plans.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Ensure stability programs meet global expectations and support shelf life, product quality, and compliance.</span></span><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">Regulatory Support:</span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Prepare and review analytical content for global regulatory submissions covering drug products, packaging, and combination products.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Serve as </span><span data-ccp-parastyle="Body Text">an analytical</span><span data-ccp-parastyle="Body Text"> lead for health authority interactions, ensuring compliant methods, data, specifications, and lifecycle support.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Lead responses to agency questions, inspections, and audits with sound analytical justification.</span></span><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">Primary and Secondary Packaging:</span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Oversee analytical evaluation of primary and secondary packaging, including integrity, extractables and </span><span data-ccp-parastyle="Body Text">leachables</span><span data-ccp-parastyle="Body Text">, and compatibility testing.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Ensure packaging studies are integrated into stability and lifecycle programs </span></span><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">Cross-Functional Collaboration:</span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Partner across Technical Operations</span><span data-ccp-parastyle="Body Text">, </span><span data-ccp-parastyle="Body Text">Clinical Supply, Manufacturing, Supply Chain, </span><span data-ccp-parastyle="Body Text">Quality, Regulatory CMC, </span><span data-ccp-parastyle="Body Text">and program teams to integrate analytical support.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Provide analytical leadership in governance, technical transfer, issue resolution, and risk-based decision-making across external sites and product teams.</span></span><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">Budget and Resource Management:</span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Manage </span><span data-ccp-parastyle="Body Text">Analytical </span><span data-ccp-parastyle="Body Text">budgets</span><span data-ccp-parastyle="Body Text"> </span><span data-ccp-parastyle="Body Text">for Drug </span><span data-ccp-parastyle="Body Text">product,</span><span data-ccp-parastyle="Body Text"> combination </span><span data-ccp-parastyle="Body Text">product</span><span data-ccp-parastyle="Body Text"> </span><span data-ccp-parastyle="Body Text">and resources effectively, including oversight of external </span><span data-ccp-parastyle="Body Text">spending</span><span data-ccp-parastyle="Body Text"> and cost optimization.</span></span><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">Project Management:</span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Lead multiple analytical activities, ensuring prioritization, </span><span data-ccp-parastyle="Body Text">timely</span><span data-ccp-parastyle="Body Text"> execution, budget control, and alignment with program </span><span data-ccp-parastyle="Body Text">objectives</span><span data-ccp-parastyle="Body Text">.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- </span><span data-ccp-parastyle="Body Text">Identify</span><span data-ccp-parastyle="Body Text"> and mitigate risks, lead troubleshooting and investigations, and communicate recommendations to senior management.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Stay current on analytical, packaging, and regulatory </span><span data-ccp-parastyle="Body Text">topics</span><span data-ccp-parastyle="Body Text"> and apply best practices to strengthen capabilities.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Drive continuous improvement across outsourced and internal operations and bring external innovation into the organization.</span></span><span data-ccp-props="{}"> </span></p>
<p><strong><span data-contrast="auto"><span data-ccp-parastyle="heading 2">Requirements:</span></span></strong><span data-ccp-props="{"134245418":true,"335559738":120,"335559739":120,"335572071":4,"335572072":1,"335572073":4278190080,"469789798":"single"}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Education: </span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline with 10+ years of pharma/biotech industry experience; or </span><span data-ccp-parastyle="Body Text">Master’s</span><span data-ccp-parastyle="Body Text"> degree with 15+ years of relevant industry experience.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Experience: </span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Extensive analytical development experience with combination products, including injectable drug product support, packaging, lifecycle development, Phase 3, process validation, launch readiness, and commercial transfer.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Experience supporting injectable synthetic peptide drug products, including characterization, orthogonal methods, bioassays, solid-state characterization, stability, and phase-appropriate analytical strategies.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Proven success managing outsourced analytical activities with global CROs/CDMOs across complex development programs.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Extensive experience with method development, qualification, validation, transfer, comparability, and regulatory submissions for drug products, devices, and combination products.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Experience with packaging assessments, including extractables and </span><span data-ccp-parastyle="Body Text">leachables</span><span data-ccp-parastyle="Body Text">, compatibility evaluations, and related analytical studies.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Familiarity with ICH, FDA, EMA, JP, and relevant ISO standards, including support for health authority interactions and phase-appropriate development.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-ccp-props="{}"> </span></p>
<p><strong><em><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Skills: </span></span></em></strong><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Strong project management and organizational skills, with the ability to manage complex initiatives and prioritize effectively in a matrix environment.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Strong problem-solving skills, especially in troubleshooting analytical challenges for drug products, devices, combination products, and packaging.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- Effective communication and collaboration skills, with the ability to influence cross-functional teams and external partners in a global environment.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-contrast="none"><span data-ccp-parastyle="Body Text">- </span><span data-ccp-parastyle="Body Text">Proficiency</span><span data-ccp-parastyle="Body Text"> in data analysis and interpretation, translating findings into clear technical, regulatory, and business recommendations.</span></span><span data-ccp-props="{}"> </span></p>
<p><span data-ccp-props="{}"> </span></p>
<p><em>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.</em></p>
<p>Ironwood currently anticipates that the initial base salary for this position could range from between $214,000- $249,795. The actual base salary will depend, in part, on the successful candidate’s 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.</p>
<p>#LI-Hybrid</p>
<p> </p>
Perks & benefits
- 401k
- Mental Wellness Budget
- Equity Compensation
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