Job Summary & Responsibilities
The Senior Technical Lead of Formulation Technology will be an integral part of the Research and Development group and will be responsible for developing strategies and managing technical issues associated with product formulation development and manufacturing related efforts. A key requirement of this position is technical knowledge and hands-on experience with polymer based and semi-solid formulations and/or drug delivery device technologies, and their scale-up manufacture. The technical focus of the position will involve technical leadership of the internal and external development efforts associated with IPM supported products and related technologies. The successful candidate should have a PhD degree in pharmaceutical sciences or related field such as polymer chemistry with 3 or more years of experience in pharmaceutical product or technology development, and supervisory experience. Demonstrated technical leadership of product development activities and experience in a “virtual” development environment is highly preferred. The successful candidate should be able to operate independently of supervision, have successful experience working in a matrix managed team configuration, and be able to provide guidance on strategic and operational issues related to IPM product and technology development efforts.
Job Responsibilities •Hands-on manage and contribute technically to the early stage development of IPM product formulations including semi-solid, vaginal tablets and films, and vaginal ring delivery devices for combination drug products. •Hands-on manage and contribute technically to IPM’s priority projects involving scale-up manufacture of vaginal gel formulations and intravaginal ring delivery devices for phase 3 trials and regulatory approval. •Support regulatory components of product development programs by contributing to regulatory submissions, data management, etc., for P1 through P3 clinical studies and regulatory approval. •Work effectively with external contractors and collaborators on all product development efforts. •Review partner data/reports and guide research as needed. •Recommend and coordinate the purchase of capital and analytical equipment for projects. •Communicate effectively up and across the organization and develop mitigation strategies for issues as they arise. •Assist in the funding efforts at IPM by technically contributing to grants and funding proposals. •Communicate cross functionally on a regular basis to ensure projects milestones are met within agreed timelines. •Write and contribute to publications/protocols/reports and occasionally present at conferences. •Keep current with advancements in formulation technology and apply to IPM projects when appropriate. •Work well in a team setting and be able to tolerate moving timelines and objectives.
Job Specifications Education/Experience: •PhD in Pharmaceutical Science or related field •Three years experience in Pharmaceutical Development Required Knowledge, Abilities/Skill Sets •Successful experiences in pharmaceutical product development, with specific focus in polymer based and semi-solids, and/or drug delivery device technology •Experience and knowledge of manufacturing sciences consistent with IPM product formulations •Experience with polymer based and semi-solid formulation and/or drug delivery device scale-up •Working knowledge and experience with regulatory aspects of drug product development, particularly in the area of CMC •Experience working with external contractors, CMO’s, consultants •Excellent written and verbal communication skills •Able to lead a cross functional team to resolve problems using structured and logical methodologies (e.g. lean six sigma techniques) •Generation of development plans •Functional knowledge of GMP compliance and Quality systems •An understanding of infectious disease or reproductive health, with focus on HIV prevention is highly preferred. Terms and Conditions Position location is negotiable, with a strong preference for the UK, Silver Spring MD, or Bethlehem-Philadelphia greater metro region. Job holder should expect fast-paced working environment with rapidly changing priorities. Some travel will be required. The International Partnership for Microbicides, Inc. is an Equal Opportunity Employer. Location Silver Spring, MD-USA or UK
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