CMC Technical Director Position Available In Wake, North Carolina

CMC Technical Director Pharmatech Associates – 4.5

Raleigh, NC Job Details Full-time Estimated:

$145K – $174K a year 22 hours ago Qualifications French Management Doctoral degree GMP Research Master’s degree 8 years Doctor of Philosophy Pharmacy Portuguese Chemistry Senior level Leadership Communication skills Full Job Description The CMC Technical Director is a full time opportunity located in Rockville, MD. This is a key leadership position within an anticipated donor-funded program, responsible for the development and implementation of CMC and product supply technical assistance activities across multiple countries in Africa. As the Technical Director for this program, they will provide strategic technical oversight and direction to all implementation of activities related to the program’s objective of increasing the supply and access of quality-assured, essential medical products, including provision of technical assistance to manufacturers (including, GMP, Dossier development and submission, business and commercialization planning), pharmaceutical sector planning/ development, product development, and technology transfer. The Technical Director will lead a team of about 5-6 technical staff and consultants involved in the implementation of CMC-focused technical activities. He/she will also oversee the implementation of activities by external partners on this opportunity. Additionally, he/ she acts as a highly visible thought leader, interfacing with global experts, partners, regional stakeholders, and leaders in supply and manufacturing, and developing and disseminating new content to advance global knowledge on sustainably increasing the supply of essential medicines. In this role, you will contribute to the public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments. The CMC Technical Director has the following responsibilities: Provide leadership for the management and implementation of CMC-related technical activities for a donor-funded project, in coordination with the Project Director. Lead and manage a team of technical experts (staff, consultants, and external partners) in manufacturing (including, GMP, Dossier development and submission, business and commercialization planning), pharmaceutical sector planning/ development, product development, and technology transfer. Define strategy and approach for technical assistance delivery across all areas related to the supply of essential medicines and manufacturing support, ensuring alignment with international best-practices and with already defined technical approaches, where relevant. Ensure consistent, high-quality, and results-driven technical assistance provision for all activities under his/ her technical scope, identifying and delivering continuous improvements based on new evidence/ information, and programmatic experience. Lead CMC work group, comprised of regional technical experts in CMC, market intelligence experts, and key partners, directed to help inform technical approach and continuous improvement. Work closely with donors to proactively identify and advise on opportunities to address supply concerns in HIV/ AIDS, Malaria, MNCH, and other areas as directed. Actively participate in a cross-functional team to ensure the objectives of programs are successfully met. Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports. Oversee resource deployment for his/ her area, with the objective of maximizing efficiency and impact and of progressively developing staff and local/ regional partners. Act as globally visible thought leader in area, actively advancing and deploying relevant knowledge based on programmatic experience and identified relevant research topics identified by donor externally in relevant forums. Interfaces regularly with key global external stakeholders/ groups in relevant areas including, with WHO pre-qualification team, Global Drug Facility, procuring agencies, and other key work groups. Who are we looking For? The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: Master’s degree in pharmaceutical science, chemistry, engineering or science related field of study required; PhD strongly preferred. Extensive [12 + years] experience leading and implementing technical assistance. programs in expanding access to global health products and pharmaceuticals. Substantive [8+ years] people management experience and skills, including ability to seamlessly manage virtual teams. Substantive [8+ years] Pharmaceutical sector experience including previous work experience with low-resource setting country manufacturers. Substantive regulatory filling experience including with but not limited to USFDA. Experience in formulation development for finished pharmaceutical products Experience working or interacting with CDMOs. Understanding of global dynamics impacting the supply of quality-assured pharmaceuticals and medical products. Direct experience with or understanding of WHO pre-qualification process. Working understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices. Demonstrated thought leadership in areas related to medical product access and supply. Strong written (especially technical writing) and oral communication skills. Willingness to travel at least 25% of the time. Additional Desired Preferences Work experience in LMICs, preferably in Africa. Fluency in French or Portuguese. Experience in at least one of the following health areas: HIV/ AIDS, malaria, AMR, MNCH. Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.