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, 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.

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 and leachables, and peptide-specific support.

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

- 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.

Regulatory Support:

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

- Serve as an analytical lead 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 and leachables, and compatibility testing.

- Ensure packaging studies are integrated into stability and lifecycle programs

Cross-Functional Collaboration:

- Partner across Technical Operations, Clinical Supply, Manufacturing, Supply Chain, Quality, Regulatory CMC, and 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:

- Manage Analytical budgets for Drug product, combination product and resources effectively, including oversight of external spending and cost optimization.

Project Management:

- Lead multiple analytical activities, ensuring prioritization, timely execution, budget control, and alignment with program objectives.

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

- Stay current on analytical, packaging, and regulatory topics and 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; or Master's degree 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 and leachables, 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.

- Proficiency in data analysis and interpretation, translating findings into clear technical, regulatory, and business recommendations.

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.

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