Director, Drug Product Development

Job Description

We are seeking a Director, Drug Product Development to lead and manage formulation development, manufacturing process development, and clinical manufacturing programs for drug products that are part of Deciphera’s growing clinical pipeline of predominantly small molecule NCEs.

This is an exciting opportunity within a very dynamic Technical Operations organization where you will have significant responsibility toward the formulation development, process development/manufacturing and regulatory approval of Deciphera anticancer drug products as both a subject matter expert and leader of cross functional teams.  It will provide ample opportunity to demonstrate your technical experience, problem-solving ability, and pharmaceutical development acuity to craft and execute drug product technical development plans and achieve project milestones that are critical to moving Deciphera’s clinical program programs forward.  The role provides for technical and regulatory exposure at all stages of the product development cycle.  The successful candidate will also have a significant role in helping to establish new scientific capabilities within the Pharmaceutical Development organization to support its long-term growth.

This position will be located at the Waltham, Massachusetts office.

What You’ll Do:

• Serve as a scientific leader for small molecule oral solid drug product development of new chemical entities (NCEs), including preclinical and clinical formulation design, manufacturing process development, technology transfer, and scale-up.
• Lead and manage cross-functional teams engaged in external development activities and cGMP manufacturing of Deciphera’s clinical bulk drug product and finished goods to ensure on-time and on-budget fulfillment.
• Review, revise and approve controlled GMP documents (Master Batch Records, Executed Batch Records, etc.) and technical reports.  Maintain internal archives of relevant development information and process data.
• Monitor, track and trend process performance during the clinical development stage. Utilize data analytics to support risk assessments, investigations, root cause identification and CAPA implementation and provide historical baseline for future operational and process-related improvements.
• Work closely with internal Chemical Development, Analytical Development, Quality Assurance, Regulatory CMC, Supply Chain and external CDMOs to ensure operational excellence with respect to timelines, budgets, and attainment of technical, regulatory and business goals/milestones.
• Develop and maintain strong relationships with Deciphera’s CDMOs and technical partners and participate in periodic business and technical meetings with relevant CDMOs.
• Participate in the selection of drug product CDMOs based upon core capabilities, capacity and track record of regulatory compliance
• Play a key role in authoring CMC content for Module 3 CTDs. Participate in RTQs and meetings with FDA, EMA and related regulatory authorities as needed.
• Build internal technical/scientific capabilities within the Drug Product Development organization, particularly with respect to workflows associated with early development (pre-clinical to clinical transition) and early-to-late drug product formulation and process refinement

Qualifications

Required Qualifications:

• A degree (B.S./M.S.) in chemical engineering, pharmaceutics, chemistry, or related life sciences discipline with at least 15+ years of hands-on technical experience and prior technical leadership roles in small-molecule pharmaceutical product development and commercialization.
• Client-based experience defining and managing drug product development and manufacturing activities through contract manufacturing organizations, with an in-depth knowledge of small molecule drug product unit operations, impact of process parameters, in-process characterization techniques, process development, and principles of cGMP.
• Established and demonstrated experience in using a wide variety of formulation concepts, including but not limited to oral solids, across multiple development programs to deliver to a project’s Target Product Profile; experience in formulation or process technologies to employ enabling formulation technologies or unique delivery systems.
• Skilled in the planning, execution, and analysis of experiments directed towards drug product development, with experience in authoring development reports and IND filings.
• Demonstrated knowledge of drug substance characterization techniques relevant towards pharmaceutical pre-formulation and formulation, and experience with fundamental application of biopharmaceutical principles.
• Strong vendor/supplier management skills with excellent communication and cross-functional collaboration skills to overcome t