Job Description

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.

Purpose/Summary:

This position is responsible for all aspects of Chemistry, Manufacturing, and Controls (CMC) drug product development from early stage to late-stage clinical development and commercialization, including development of efficient and scalable manufacturing processes, technology transfer, manufacturing of clinical supplies, and management of supply chain for clinical supplies. She/he is also responsible for preparation and review of all CMC regulatory filings.

At this stage, the primary activities are focused on supporting Phase 3 clinical trials, including manufacturing clinical supplies, managing resupply needs, and overseeing the clinical trial supply chain and drug/device combination product interface.

The Head of Drug Product Development leads activities of an internal multifunctional team and network of external Contract Development and Manufacturing Organization (CDMO) partners working on all aspects of CMC development. Functional responsibilities as project leader include formulation and manufacturing process development, oversight of drug product development, technology transfer and scale-up, and oversight of packaging and labeling, clinical supply chain, and CMC project management for drug product and drug/device combination product interface related activities. Must possess strong leadership experience including strong CMC expertise and good technical understanding of the inter-disciplinary nature of drug development demonstrated by previous experience with injectables and drug/device combination products. She/he will collaborate closely with cross-functional internal and primarily external (CDMOs) team members in CMC development, Regulatory, Quality, Clinical Operations and Development during all phases of product development Ph 1- Ph 3, technology transfer, validation, manufacturing and filing IND, IMPD, NDA, MAA registration.

Essential Functions:

• Lead internal and CDMO Drug Product teams and represent Drug Product Development in multidisciplinary project teams as a project leader, work collaboratively to ensure project progression, and communicate Tech Ops strategy and related challenges.
• Encourage innovative, cross-functional thinking, and engagement of outside expertise as appropriate to help further Tech Ops/Corporate goals
• Ensure robust planning and execution of product development efforts across Ironwood's portfolio of development candidates from IND, Ph1, Ph2, Ph3 to commercialization. Proactively identify and mitigate risks to advance products in a timely manner.
• Ensure effective communication with key partners internally (particularly program management, regulatory, clinical development, and quality) and with an external CDMO network.
• Set Drug Product team budget and have financial accountability for drug product development activities per the annual operating plan.
• Responsible for Drug Product CDMOs timelines and Drug Product functional planning by providing technical oversight to ensure that Ironwood’s development and clinical manufacturing needs are met.
• Provide oversight to the clinical trial supplies team managing the inventory/delivery of Investigational products.
• Apply formulation and manufacturing principles, theories, and techniques to product development, and ensure development of the best possible phase-appropriate formulations.
• Supervise Drug Product and Clinical trial Supply scientists internally and externally to deliver on chemical, formulation, and analytical drug product development goals.
• Enable risk-based and compliant development practices: Identify and evaluate risks and provide recommendations to close via internal or external collaborations. Ensure development activities are documented per Ironwood documentation policies and underlying data are traceable.
• Author and/or review technical reports and relevant CMC sections for regulatory submissions (INDs, IMPDs, NDAs, etc.). Accountable for content development of FDA and exUS regulatory filings in collaboration with Regulatory, Quality, Supply Chain and members of the Development teams.

Requirements:

• PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry, or related scientific field with at least 15 years of industrial experience with at least 10 years of senior leadership experience in leading CMC/formulation teams especially in the injectable space (more specifically vials, both liquid and lyophilized drug products).
• Experience with injectable drug products containing synthetic peptides.
• Experience with leading drug product teams for injectable products during Phase 3, process validation, launch readiness and transition to commercial production.
• Experience with early phase development (pre-clinical, and Phase 1) a plus.
• Demonstrated experience supporting drug–device combination product development, with specific expertise in fill‑finish processes (e.g., prefilled syringe, autoinjector, dual-chamber cartridge) and conducting drug product–device / container compatibility evaluations.
• Experience with clinical studies and supply chain management oversight a plus.
• Comprehensive understanding of all aspects of CMC including process and formulation development, analytical science, regulatory, and quality.
• Strong group leadership, communication, and collaborative skills (both cross-department and with development partners). Experience working with global teams is strongly desired
• Experience in managing development and manufacturing activities at global CDMOs
• Experience with synthetic peptide manufacturing processes, injectable drug product manufacturing, and finished goods primary packaging
• Working knowledge of approaches for characterization of solution and solid-state properties of materials, and technologies for delivery of synthetic peptides
• Excellent data analysis skills and the ability to make recommendations that impact the scientific and business goals of the company. Ability to articulate complex issues and ideas with clarity to enable understanding and direction.
• Solid understanding of ICH, FDA, EMEA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of product development
• Strong understanding of drug–device combination product development, including primary container interactions, fill‑finish considerations, and drug product–device compatibility
• Experience with submissions and interactions with regulatory agencies regarding CMC issues during product development and primary container/packaging for drug-device combination products. Thorough knowledge of INDs, IMPDs, MAAs, NDAs, etc.
• The ability to work successfully in both a team/matrix environment as well as independently is required
• The ability to influence cross-functionally to enable development improvements and team performance.
• Good communication, project management, and interpersonal skills
• Effective and innovative problem-solving skills

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

Ironwood currently anticipates that the initial base salary for this position could range from between $246,000 to $286,650. 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.

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