Ambitious Drug Development expansion plans have led to the establishment of this exciting management position. This opportunity offers a rare chance to make a key contribution towards building a successful product portfolio in this ambitious young company.
The Drug Development Manager will manage drug development/CMC activities, and will be responsible for programs from proof-of-concept feasibility through commercial registration. The future portfolio may include a broad array of drug products, medical devices and combination products including drug delivery devices for sterile injection, wearable, and nasal spray products as well as diagnostic devices for detecting public health threats. You will be required to be proficient in a range of technologies from standard pharmaceutical dosage forms to more sophisticated drug delivery, including sustained or controlled-release dosage forms, parenteral injectable, as well as novel combination product concepts. You will manage and direct the technical activities of internal drug development staff in addition to building and managing our network of external collaborators. You will have strong leadership skills and a track record of drug/combination product development that you can use to develop and mentor the internal drug development staff.
Initiate development programs and be the lead on specific projects.
Specify the technical requirements for the drug development program, including performance criteria, materials, analytical methods, test protocols, packaging (clinical and commercial) and manufacturing methods.
Manage ongoing technical programs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt.
Prepare, in conjunction with Regulatory Affairs, the appropriate sections of regulatory filings for the products that they manage.
Work closely with the device engineering, combination product and Tech ops teams to develop products with a focus on transferring the formulation process to ensure reliability, manufacturability and commercial longevity.
Enhance internal processes, implementing QbD best practices and develop innovations for continuous improvement
Create intellectual property covering drug/combination products.
Work closely with business development to identify market opportunities for the device platform technologies
Work closely with the Grants & Contracts team to respond to RFPs and win external funding
PhD or MS in Pharmacy, Chemistry, Chemical or Materials Engineering (or a related science discipline) with a minimum of 5 years+ experience in pharmaceutical development.
Direct experience of pharmaceutical development, QbD and target product profiling, drug delivery of sterile products and drug-device combination products preferable.
Broad exposure to established and novel drug delivery technologies is preferred.
Experience in development of solid dosage forms, controlled release formulations, long acting injectables, implantable and wearables is desired.
Knowledge of drug substance manufacture and analytical chemistry is also preferred.
Direct experience with generating CMC documentation for regulatory filings for drug and drug-device combination products.
Proven project management and trouble-shooting skills for technical programs.
Proven leadership (on site and remote) of a technical team, including performance management.
Proven ability to direct external development external CMO/CDMOs to project completion under rigid timelines.
A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity
Excellent organizational ability and working well in a fast-paced, team-oriented, collaborative way is required.
Excellent communication skills and strong interpersonal skills.
Highly organized, with exceptional time management and prioritization
Critical thinking evaluation of process problems
Strong work ethic
Flexibility to travel on company business when required.
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