Job Summary & Responsibilities
The Associate Director Process Chemistry will be an integral cross-functional role within the Product Development group. This position is responsible for oversight of drug substance activities for all IPM development and future commercial projects. Specifically, the candidate will be expected to be successful in the following areas:
CMO oversight – supply and relationship management
Technical management – GMP and non-GMP process development, process improvement, transfer to commercial manufacturing, etc.
Communication and reporting of activities (internally and externally)
Authoring documents for regulatory submissions
Interactions with health authorities
Assistance with and/or leadership of projects related to other CMC areas on an ‘as needed’ basis
The position requires an in-depth understanding of the drug development process, especially in the functional area of drug substance synthesis and process development/manufacturing, as well as working knowledge in multiple other aspects of development such as formulation, analytical development, and CMC-Regulatory. The successful candidate should also demonstrate a significant understanding of budgeting, business process execution and technical project management.
To perform this job successfully, an individual must be able to perform and/or manage each essential duty satisfactorily:
Provides consistent and high level support to all projects, including developing and managing relationships with new and existing CMOs and service providers.
Accountable for all technical activities regarding drug substance, as well as timelines, budgets, contracts, and reporting.
Coaches and mentor cross-functional team members with regard to relevant pharmaceutical/drug development knowledge, tools and processes
Effectively manages cross functional teams (as appropriate) driven at advancing pharmaceutical development projects
Authors high quality CMC documentation for regulatory submissions
Prepares/supports preparation of manuscripts and presentations to support IPM microbicide field supremacy
Represents PD and/or IPM as needed at external and internal meetings and conferences
Works well in a remote team setting and is able to tolerate moving timelines and objectives; deals well with ambiguity
Acts proactively and maintains a high level of organization and transparency
Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:
Education and Experience
Ph. D. in chemistry (exceptional candidates with an M.S. in Organic Chemistry may be considered)
Must have seven plus (7+) years of hands-on experience in a Pharmaceutical/Drug Development organization with focus in drug substance Process Development
Demonstrated expertise in drug substance Process Development and Process Improvement
Demonstrated exceptional technical writing and presentation skills
Experience preparing multiple regulatory submissions (CTD 3.2.S. sections) for IND/IMPD and NDA/MAA
Experience working on technical projects with external contractors and consultants
Leadership experience with cross functional product development teams (with or without direct reports)
Experience in risk management and mitigation – executes creative solutions to challenging problems
Knowledge, skills, and abilities
Knowledge and hands-on experience participating in and overseeing drug substance development activities
Expert working knowledge of ICH, FDA and EMA guidelines on drug substance-related topics
Thorough understanding of the drug development process
Excellent written and verbal communication skills
Ability to work independently, and have demonstrated ability to lead either with or without direct reports.
Be able to understand and manage a varied portfolio of projects, act as the main point of contact to senior scientific collaborators, and be able to assess and track budgets and timelines associated with these activities
Proficiency in MS Word, Excel, PowerPoint, Project
Terms and Conditions
Position can be based out of a home office or the Silver Spring office. Position may require national/international travel. Job holder should expect fast-paced working environment. IPM is an Equal Employment Opportunity employer.
This job description should not be construed to imply that these requirements are the only standards for the position. Other duties will be assigned. IPM has the right to revise this job description at any time. IPM is an “at will” employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and IPM.