Associate Director, Formulations
Posted on Apr 5, 2021 by Mallinckrodt Pharmaceuticals
Mallinckrodt Pharmaceuticals is seeking a highly motivated and experienced Associate Director in generic dosage product development. The successful candidate for the position will lead and oversee planning and execution of formulation development and tech transfer for scale up, registration and validation activities at both internal and external manufacturing sites. This position will be a technical mentor for junior formulation scientists to guide the successful generic dosage products. The candidate will serve as a key driver to identify, analyze, suggest and own improvement actions to build a high performance organization. This position may require some travel to assist in tech transfer and manufacturing-related activities across the GMP manufacturing sites.
Leads and oversees the formulation development and tech transfer of generic oral dosage products.
Manages formulation and tech transfer-related activities including detailed planning of the formulation and process development, scale-up activities, registration batch manufacturing and pre- and validation support at a commercial manufacturing site.
Responsible for working with lead scientists to establish sound development strategies and modifying strategies as projects advance or technical challenges are encountered.
Works in close collaboration with other functional teams including Analytical, Project Management, Clinical, Quality, Regulatory, Legal and Commercials.
Actively communicates, collaborates with and contributes to other functional areas to solve problems and achieve goals.
Authors and reviews formulation related sections for regulatory filings, development reports and other development related documents.
Provides troubleshooting at scale-up/commercial level.
Manages multiple projects; manages project timelines and deliverables.
Manages, coaches, mentors, and advises other formulations scientists in order to meet project goals and timelines.
Other duties as assigned with or without accommodation.
Ensures work practices and procedures are safe. In addition, ensures compliance with corporate and departmental safety requirements and safety training.
PhD in pharmaceutical sciences or related science field with minimum of 8 years of experience in pharmaceutical formulation development, working on generic immediate and extended release oral dosage products, or;
MS degree with minimum of 10 years of related experience, or;
BS with minimum of 14 years of related experience required.
Minimum of 3 years of experience in managing a formulations development team.
Extensive knowledge of manufacturing process-related equipment for oral dosage products.
In-depth, hands-on experience in formulation for oral solid and liquid pharmaceutical dosage forms and various delivery system required.
Hands-on experience supervising, leading and training scientist and other laboratory personnel required.
Advanced working knowledge of pharmaceutics, pharmaceutical sciences, and clinical pharmacokinetics required.
Demonstrated knowledge, experience, and track record in pharmaceutical manufacturing process in the oral dosage area.
Working knowledge of evaluating patents and literature prior arts.
Working knowledge of FDA and ICH guidelines to comfortably lead multiple projects from concept through validation and launch.
General knowledge of pharmaceutical analytical techniques.
Mastery of pharmaceutical concepts, and application of those concepts and techniques to effectively resolve technical issues.
Extensive experience in technical writing, including not limited to protocols, summary reports, product development reports and CMC-related documents for regulatory filings.
Excellent verbal and written communication skills.
Excellent communication and interpersonal skills to collaborate with others including both internal teams and external collaborators.
Formulation development team management experience required.
This position reports to the Sr. Director Formulations and has direct reports.
Partners closely with marketing, clinical, regulatory affairs, legal, project managers, and manufacturing.
Typical laboratory environment.
Ability to work in the lab.
Ability to travel 10 - 20%.
Must pass a security clearance.