Director, Drug Product Development« Back
Job Title: Director, Drug Product Development
Location: Lawrence, Kansas
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston in Waltham, Massachusetts. Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas.
We offer an outstanding culture and opportunity for personal and professional growth based on these key principles:
• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve
We are seeking a Director, Drug Product Development to be responsible for the leadership and management of drug product development and manufacturing activities, including activities at contract research and manufacturing organizations, to support early phase clinical studies. Partnering with drug substance and analytical development teams, this individual will be responsible for the completion of IND-enabling development and drug product manufacturing for small molecule NCEs. The candidate will ensure timely manufacturing of drug product to support early clinical development programs. The Director will further contribute active support for regulatory CMC filings.
This position will report to the Vice President, Chemical and Pharmaceutical Development and be located in the Lawrence, KS office.
Design and implement phase-appropriate drug product formulation development and supply strategies to support Deciphera’s pipeline and early clinical programs
Serve as primary contact and manage CMOs/CROs in conduct of DP process development, process optimization, scale-up and clinical manufacturing.
Work closely with chemical and analytical development functions
Provide critical pre- and post-review of manufacturing batch records and integrate results into CMC regulatory filings
Author and review regulatory reports/documents such as IND filings, IND updates, product development reports, quality summary, master batch records and other key reports/documents
Potentially represent company in meetings with regulatory agencies
Work with CMC senior leadership to create and communicate project strategy, plans and schedules that are aligned with company objectives and portfolio prioritization
Advanced degree (PhD preferred) in scientific or engineering discipline and 10 years of hands-on experience in pharmaceutical industry with drug product development for small molecules
Experience in solid oral dosage forms.
Clear written and verbal communication skills. Must be able to communicate effectively with executive leadership, consultants and contract research/manufacturing organizations
Ability to direct and guide the work of CMOs.
Understanding of cGMP manufacturing
Strong project management experience
Experience in process scale-up and transfer
Demonstrated ability to multi-task under pressure and ability to prioritize competing activities
Prior authorship of INDs, IMPDs
Late stage development and commercialization experience is a plus
Familiarity with US and international regulatory CMC guidance and processes
Prior experience filing NDAs highly desirable
Excellent computer skills (e.g., Microsoft Office, Excel, Project)
Strong organizational skills with attention to detail and ability to manage multiple projects at once
Ability to work both independently and in a team focused environment
Ability to travel up to 15% to support CDMO relationships/manufacturing
Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.