The Associate Director of Formulation Development will support the drug product development function. Responsibilities will include leading, planning and managing the technical and business-related activities associated with drug product development and manufacturing of solid oral dosage forms at contract development sites.
Responsibilities:
Use knowledge and experience to design and select appropriate formulations for toxicology and first in human studiesSupport formulation and process development, technology transfer and clinical manufacturing activities.Develop strategies and execute plans for drug product development in accordance with timelines and requirements of overall development programs.Select and manage contract development and manufacturing vendors.Negotiate and approve statements of work and quotes.Review and approve manufacturing documents, protocols and reports.Work closely with other internal functional groups to ensure that all drug product requirements for clinical trials are met.Work closely with QA to ensure clinical supplies meet quality requirementsPrepare CMC sections of regulatory filings.15-20% travel expectedPreferred Skills, Qualifications and Technical Proficiencies:
Technical expertise in solid oral dose formulations for small molecules.Must have hands-on experience in formulating drugs with limited solubility and is knowledgeable about technologies employed to enhance bioavailability.Must have experience in formulation and process development from early to late phase development.Solid understanding of ICH, FDA, EMA guidances in CMC and Quality areasGood working knowledge of GMP requirements for drug product development and manufacturing.Experienced in writing CMC sections of regulatory filingsStrong written and oral communication skills. Must be comfortable making presentations in team meetings and must have the ability to communicate complex technical information clearly and concisely.Good project management and leadership skills, with ability to lead multiple programs at the same time.Enjoy working in a fast-paced environment within a matrix organization.Preferred Education and Experience:
PhD in Pharmaceutical Sciences or relevant technical field with 6-8 years experience or MS with 10+ years experience.Minimum of 5 years in managing outsourced drug product development activitiesThe pay range that the Company reasonably expects to pay for this headquarters-based position is $181,000 - $213,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
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