Head of Drug Product Development

Requirements

• PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry,

Benefits

Additional Information

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.