Director, CMC Process Development

The Position

The Director/Senior Director of CMC Process Development will be responsible for the overall supervision of the Company's process development group. The incumbent will provide Process Development related guidance supporting the Company's innovative clinical programs using Arrowhead's siRNA platform, assist with contract manufacturer management, and will have a leadership role in expanding Arrowhead's internal group and representing the CMC Process Development team on interdisciplinary teams within the Company. S/he will communicate effectively and interact in cross-functional teams, to include the Company's Toxicology, Manufacturing, Analytical Development, Supply Chain Management and Regulatory Affairs teams, as well as external contacts such as other regulatory professionals, external research partners, contract manufacturers, and corporate partners. This position will report to the Group VP, CMC.

Responsibilities

• Prepare and execute detailed product development plans for new and existing programs
• Provide supervision and project management for internal PD personnel as well as implement and help oversee outsourced contracts
• Define and implement specifications and stability management strategies for toxicology and clinical material
• Provide support and guidance to Regulatory Affairs on scientific and CMC-related issues. Oversee and author key components of the CMC sections for regulatory filings, including INDs and subsequent amendments; ensure that the regulatory CMC strategy meets global regulatory CMC requirements for the Company's products
• Coordinate external Contract Manufacturing Organizations (CMOs) towards successful execution of technical and manufacturing campaigns for multiple development programs; provide identification, evaluation, selection, and budget management of CMOs and have responsibility for developing positive and effective working relationships with suppliers
• Participate in technology transfer of products from research & development to internal manufacturing and CMOs; provide cGMP manufacturing expertise
• Provide technical expertise in development and optimization of manufacturing processes
• Review current SOPs and recommend/generate new relevant manufacturing-related SOPs, batch records, change controls and regulatory documentation, etc.
• Work with project management in ensuring drug supply is uninterrupted in toxicology programs and clinical trials
• Manage and/or guide pre-formulation and formulation development activities for parenteral dosage forms; design and manage stability programs in support of IND and follow on regulatory filings
• Support the Senior Management Team in developing budgets and forecasts; prepare operating data and special reports to Senior Management and the Board of Directors, as required

Requirements:

• Ph.D. in Chemical Engineering, Chemistry, or a related scientific discipline with at least 10 years' relevant experience in chemical synthesis, writing CMC documentation for regulatory submissions or product manufacturing
• Knowledge of the CMC development process from pre-IND/Phase I through late phase/product registration/commercialization with specific expertise in reviewing data (e.g., release/ stability/ in-process) and involvement in setting strategies around drug substance and drug product specification
• Experienced with cGMP practices and ICH/FDA guidance documents governing manufacturing, stability testing, and drug product formulation
• Proven track record of mentoring and supporting direct reports and
• Proven leadership and management abilities with projects and teams; demonstrated ability to work in a technical team environment and evidence of successful cross-departmental interactions is essential
• Excellent interpersonal, organization, negotiation, and communication skills. Ability to organize technical projects and manage multiple sub-projects simultaneously
• Ability to exert influence diplomatically and have an impact in and outside of the organization without direct authority
• Highly motivated team player willing to contribute to a growing biotech organization

Preferred:

• Experience with the full range of pharmaceutical configurations, including with small molecules and macromolecules (oligos, proteins, peptides)
• Knowledge of parenteral dosage products