Sr Scientist 1, Chemical Drug Product and Device Technologies (#2729)

CMC Drug Product Partner Team Lead (PTL)

Role Summary

Our company is seeking a highly motivated individual with drug product development experience to lead the CMC drug product partner team for gene therapy products. The drug product partner team is responsible for all aspects of drug product and finished good to support the CMC deliverables. The drug product partner team comprises members from the CPDT organization, Manufacturing, Packaging and Engineering Development, and other cross functional teams. The scope of DP partner team includes but is not limited to technology transfer, DP formulation development and optimization, primary packaging design, DP process validation execution, fill/finish process development & optimization, primary and secondary label development, DP packaging and shipping design and development, and commercial product configuration design/development.

The main task of the CMC Drug Product Partner Team Lead (PTL) is to provide technical and team leadership to the members of the partner team, as well as representing the partner team at the CMC team level. The PTL is responsible and accountable for managing DP partner team(s) deliverables and communication to CMC and management. An understanding of the various functions represented within the partner team is required, to enable the PTL to provide oversight of cross-functional activities within the partner team, to bring about the successful planning, monitoring, and executing of deliverables of the CMC Program Execution Plan. Routine reporting of activities, issues, strategy, risks, etc. to CMC and management is expected. The PTL serves as a scientific monitor for formulation development, technology transfer and manufacturing at CDMOs. The role generally involves making use of scientific expertise and understanding of the industry, to develop and contribute to complex company objectives.

Role and Responsibilities

• Plans experimental design and strategic planning of drug product formulation development throughout the non-clinical, clinical, and commercial phases.
• Collaborates in a matrix organization with Research, Process Development, Quality Control, Analytical Chemistry, MSAT, Manufacturing (internal and external), Market Planning, and Regulatory Affairs to deliver project objectives.
• Provides scientific guidance and consultation to junior scientists on experimental designs, trouble shooting, data interpretation and technical challenges.
• Develops conceptual designs and experiments to solve technical issues.
• Leads the development and optimization of drug product formulations.
• Leads cross-functional CMC Drug Product partner team, represents the partner team, not just a functional group in CMC meetings.
• Orchestrates with other partner teams to develop options/recommendations to CMC.
• Has a clear understanding of experimental results and provides recommendations to CMC teams based on input from DP partner teams.
• Responsible for timely and clear communication of all relevant information to and from the partner team to the CMC team and functional managers.
• Identifies, mitigates, and if necessary, escalates program and/or partner team deliverable risks (quality, timeline, scope) through CMC
• Accountable for creating, maintaining, and updating status of scheduled activities/milestones to the CMC PM.
• Represent drug product team at Core Team meetings, responsible or accountable for drug product team deliverables
• Support new CDMO selection and CDMO site due diligence evaluations and visits
• Provides feedback on study protocols and reports to support formulation development, technology transfer or manufacturing at CMOs or CDMOs.
• Provides updates of project status, risks, and mitigation strategies in the context of overall program goals.
• Reviews written technical reports, contributes to regulatory submission documents.
• Contributes to the overall strategy, performance, and direction of Chemical, Drug Product and Device Technologies function.

Education Required

Ph.D. in Biochemistry; Pharmaceutics Sciences, or related fields with 5+ years of industry experience

MS or BS with extensive industry experience

Experience Required

• Experience leading multi-disciplinary team and providing oversight of cross-functional activities within the team, to bring about the successful planning, monitoring, and executing of deliverables.
• Experience with designing parenteral formulation screening and optimization studies, experience in gene therapy drug product development is preferred.
• Experience with parenteral drug product formulation development, characterization, testing, quality risk assessment and CMC regulatory guidance and filings.
• Strong leadership and team management skills. A strong team player with good collaborative and people skills.
• Strong organization and prioritization skills, ability to facilitate and drive program forward
• Strong written and verbal communication skills, and familiarity with representation on inter-disciplinary and cross-functional teams.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Highly motivated with the ability to resolve technical issues, develop and implement corrective solutions, be able to quickly adapt and respond effectively to changes
• The candidate will have a broad knowledge of regulatory, scientific, and technical issues concerning drug development applications.
• Experience in authoring/reviewing CMC sections for regulatory filings with health authorities.
• Excellent technical writing skills, experience authoring/reviewing development reports, batch records, regulatory filings, or other documents.
• Supervisor Responsibility

May lead 1-2 associates

Solid understanding and familiarity with pharmaceutical characterization and testing equipment such as HPLC (RP-HPLC, SEC, ion exchange chromatography), DSC, UV spectrophotometry, capillary electrophoresis, particle size measurement techniques, DLS, Differential Scanning Fluorimetry (DSF), etc.

Operational knowledge and experience with large molecules fill finish operation and tech transfer.

Knowledge of parenteral formulations (liquid or frozen), processing and packaging materials.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.