The Director, Analytical Sciences will be an integral part of the Product Development group and will be responsible for developing strategies and managing technical issues associated with product development testing efforts. The technical focus of the position will involve analytical and bioanalytical testing in support of pre-clinical, clinical, and product registration stages of drug or drug-delivery device development. Additionally, oversight in the manufacturing of drug substances is required.
The position is also involved in due diligence activities, resource development, publication production and presentations on behalf of IPM, and other administrative duties.
• Manage Analytical Sciences support efforts for development, pre-clinical, and clinical development/manufacture (Phase I – III and NDA/MAA)
• Manage Analytical Science direct reports
• Contribute technically and manage fully all analytical chemistry and bioanalytical aspects of product development. Also need to manage the outsourced synthetic chemistry needs for each drug substance.
• Contribute to and/or support the formulation development efforts for IPM products internally as well as with external contracting organizations.
• Support the production of CMC-related documents intended for submission to regulatory agencies, compiling or preparing analytical sections of the CTD supporting drug substance and drug product
• Contribute to the design and development of GMP analytical support activities (method development, validation, trouble-shooting).
• Provide leadership to product development teams in relevant GMP regulatory analytical expectations.
• Work well in a team setting and be able to tolerate moving timelines and objectives
• Contribute to the development of departmental and organizational strategic and operational plans
• Manage multiple projects concurrently and set priorities in conjunction with senior management in a fast-changing, results-oriented R & D environment
• Support IPM due diligence efforts
• Develop and manage a wide range of collaborations and contractor activities.
• Contribute to IPM resource development activity
• B.Sc/MS/PhD. degree in chemistry, analytical chemistry,pharmaceutics or related field with 10 or more years of experience in pharmaceutical product development and/or analytical chemistry. Applicable experience will be considered in conjunction with specified educational requirements.
• Able to operate independently of supervision, and provide guidance on strategic, operational, and compliance issues related to IPM Analytical support needs.
Knowledge, Skills, and Abilities
• Analytical chemistry expertise (instrumentation, methodology, development and validation)
• Familiarity with synthetic chemistry concepts
• Working knowledge and experience supporting formulation development, pre-clinical studies, clinical supply manufacturing/testing
• Extensive knowledge of EU/US GMPs related to analytical testing; extensive knowledge of ICH guidelines; knowledge and experience with global registration requirements related to drug substance and drug product testing
• Capacity to make leadership decisions related to product development
• Experience working with external contractors, CMO’s, consultants
• Excellent written and verbal communication skills
• Generation of budgets and development plans
• Demonstrated expertise in GMP compliance
• Experience in supporting regulatory activities
• Ability to adapt and manage change
Terms and Conditions
Position can be based out of a home office, and will require travel to IPM vendor and/or silver Spring sites, and may require national/international travel.
Location:Philadelphia, PA or Silver Spring, MD