Deciphera Pharmaceuticals Inc.
Job Title: Manager/Sr Manager, Drug Product Development
Job Number: 24845
Location: Lawrence, KS
The Manager/Sr Manager, Drug Product Development within Technical Operations will be part of a team responsible for development and manufacture of drug product (DP) for Deciphera’s small molecule NCEs in clinical development. Focusing on early to mid-stage development programs of oral solid dosage (OSD) presentations, the individual will work in a cross functional CMC team environment with colleagues from drug substance, analytical development, QA, Supply Chain, and DP MS&T to plan, coordinate, and execute DP development strategies and ensure timely manufacturing to support clinical DP supply. The successful candidate will significantly contribute to creation of development plans for new DP formulations, perform analysis and interpretation of data, and chart the course for staged improvements to DP formulations and processes during each development phase. The Manager/Sr. Manager will have responsibility for oversight of development and clinical manufacturing activities at Deciphera’s external DP contract development and manufacturing organization (CDMO) partner sites.
In addition, the successful candidate will collaborate to study critical formulation and process parameters, perform scale-up studies and technology transfers, troubleshoot process related issues and contribute to root cause analysis for manufacturing deviations and investigations. The Manager/Sr. Manager will also ensure that drug product development and clinical supply timelines are met, and will contribute support to regulatory CMC filings.
The position will report to the Director of Drug Product.
- Plan and implement early to mid-stage Drug Product formulation development, process evaluation, and manufacturing activities at Deciphera’s suppliers in accordance with documented work plans and/or cGMP requirements.
- Author, review and approve documents related to development activities and GMP operations as requested and appropriate, including development plans, DP MBRs, and EBRs.
- Oversee the implementation and/or technology transfer of drug product processes and process improvements into CMOs. Act as Person in Plant to provide Deciphera oversight during CMO drug product manufacturing activities.
- Monitor deviations and process/operational changes; ensure appropriate technical and management visibility within Deciphera to these events and facilitate feedback and decisions to the CMOs.
- Participate in preparation and review of CMC sections of regulatory filings.
- As a member of internal and external CMC teams, develop and execute DP development plans and schedules that represent the appropriate level of detail and have accurate resource planning estimates to support development team objectives.
- Participate in periodic business and technical review meetings with relevant DP CMOs.
- Keep management informed of any significant risks to CMC timelines and/or budgets relating to drug product development and manufacturing.
- Ability to travel up to 25%.
- BS/MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or comparable scientific degree
- 8-10+ years of experience in the Biotech or Pharmaceutical industry focused on small molecule drug product development and manufacturing (extensive hands-on experience in the development and clinical manufacturing environment towards the development of oral solid dosage DPs for NCEsis preferred).
- Experience working in a contract manufacturing environment 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 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 is desirable.
- Skilled in the planning, execution, and analysis of experiments directed towards DP development, with experience in authoring or contributing to development reports and IND filings.
- Strong verbal and written communication and interpersonal skills; demonstrated ability to apply these skill-sets to advance Deciphera’s positions while cultivating positive relationships with CMO partners
- Hands-on, can-do individual with a collaborative personal style and the ability to work well in a fast-moving team/collaborative environment.