Director, Drug Product Development

Company Description

Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom.  We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.  

See here for more details on our portfolio.

We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here. 

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 technical and resource challenges.
• Thorough knowledge of ICH requirements, approaches for implementation of Quality by design (QbD) principles and Module 3 CTD content. 
• Experience in developing, implementing, and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.
• Ability to work successfully in both a team/matrix environment and independently, as required.
• Pragmatic, solution-oriented thinker with strong interpersonal skills and the ability to influence others, negotiate during situational conflict, and establish the best forward path for Deciphera in the face of competing points of view.
• Ability to travel (25%) to CDMO domestic and international sites to oversee activities, as required.
• Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project) and JMP (or similar statistical tools).

Preferred Qualifications:

• Ph.D. degree in chemical engineering or pharmaceutics with 10+ years of hands-on technical experience and prior technical leadership roles in small-molecule pharmaceutical development is highly preferred.
• Experience and track-record across all stages of Clinical Development (early to late-stage) with formulating, developing and commercializing drug products of NCEs.
• Specialized knowledge and experience with respect to pharmaceutical pre-formulation workflows, pre-clinical formulation techniques and analysis, physical/chemical characterization, biopharmaceutical classification/assessment of new molecules, or drug product process optimization and scale-up.
• Knowledge and experience with developing other formulation presentations (injectables, topicals, implants/sustained release, etc) or molecular modalities (oligonucleotides, peptides, proteins, mAbs, ADCs, etc.) will be considered a valuable additional quality of candidates.

Additional Information

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Monthly cell phone stipend
• Internal rewards and recognition program
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance for family
• Short and Long Term Disability insurance
• Health savings account with company contribution
• Flexible spending account for either health care and/or dependent care.
• Family planning benefit
• Generous parental leave
• [if applicable] Car allowance

Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.