Ironwood Pharmaceuticals

Ironwood Pharmaceuticals

Head of Drug Product Analytical Operations

Boston, Massachusetts, United States · Director

Sponsorship not specified$214k-$250kDetected 50 days ago
Data AnalysisProject ManagementSupply ChainFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingOrganizational Skills

About the role

  • 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.

Responsibilities

  • 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 role provides strategic and technical leadership across Technical Operations, Quality, Regulatory CMC, and external partners to support development, technical transfers, process validation, regulatory submissions, clinical bulk supply 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.
  • Lead and develop the Analytical Drug Product team, fostering excellence, collaboration, innovation, and continuous improvement.
  • Build external partnerships and review key technical documents to support compliant execution, issue escalation, and lifecycle changes.
  • Lead analytical strategy for drug products, devices, and combination products, including methods, characterization, stability, extractables and leachables, and peptide-specific support.
  • Partner with CMC and product teams to support development, regulatory submissions, clinical bulk supply including release and stability, and lifecycle plans.
  • Ensure stability programs meet global expectations and support shelf life, product quality, and compliance.
  • Partner across Technical Operations, Clinical Supply, Manufacturing, Supply Chain, Quality, Regulatory CMC, and program teams to integrate analytical support.
  • Manage Analytical budgets for Drug product, combination product and resources effectively, including oversight of external spending and cost optimization.

Requirements

  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline with 10+ years of pharma/biotech industry experience
  • or Master's degree with 15+ years of relevant industry 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 and leachables, compatibility evaluations, and related analytical studies.

Nice to have

  • company-sponsored 401(k) with matching contributions

Skills

  • Proficiency in data analysis and interpretation, translating findings into clear technical, regulatory, and business recommendations.
  • Ironwood is an Equal Opportunity Employer.
  • Ironwood currently anticipates that the initial base salary for this position could range from between $214,000- $249,795.

Compensation

  • Ironwood currently anticipates that the initial base salary for this position could range from between $214,000- $249,795.

Benefits

  • Serve as an analytical lead for health authority interactions, ensuring compliant methods, data, specifications, and lifecycle support.
  • Familiarity with ICH, FDA, EMA, JP, and relevant ISO standards, including support for health authority interactions and phase-appropriate development.
  • 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.

Company info

  • 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.
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