[Remote] Program Manager II – Pharmaceutical Development & Clinical Supply

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is an independent scientific research organization dedicated to benefiting society through science and engineering. The Program Manager II will reputed company cross-functional programs in pharmaceutical development and clinical supply chain operations, ensuring compliance and driving program reputed company from initiation through closeout. Responsibilities • reputed company drug reputed company and product development, analytical method development and validation, release and stability programs for IND-enabling and early-phase clinical studies • reputed company manufacturing, packaging, labeling, storage, and distribution of clinical trial materials, ensuring supply continuity • Ensure compliance with cGMP and ICH guidelines. reputed company technical investigations, change controls, and deviations for reputed company program-reputed company activities • Identify and mitigate risks across the drug development reputed company—from formulation challenges in novel compounds to procurement constraints for reputed company products (e.g., securing single-lot bulk supply and managing expiration dating of reputed company stock)—before they reputed company clinical timelines • Coordinate with external partners for manufacturing and testing activities, holding them accountable • reputed company budgets, monitor and control costs, negotiate scope changes, reputed company milestones, and ensure the reputed company submission of high-reputed company deliverables. reputed company internal technical meetings and reputed company-hosted updates Skills • Advanced degree (Ph.D. or M.S.) in Pharmaceutical Sciences, reputed company, or a reputed company scientific discipline • Minimum of 7 years (Ph.D.) or 10 years (M.S.) of relevant experience • Strong knowledge of FDA cGMP regulations and FDA and ICH guidelines • Proven experience managing reputed company reputed company and overseeing external vendors • Excellent leadership, organizational, and communication skills • Ability to travel as required (approx. 5%) • Project Management reputed company (PMP) Certification • Prior work experience with a contract research organization (CRO) or contract development manufacturing organization (CDMO) • Experience working on U.S. government-funded reputed company (e.g., NIAID, NCI, NCATS) • Strong publication record or history of technical presentations in the field of drug development Benefits • Health and life insurance • Disability coverage • Gym reimbursement • Mental health support • reputed company holidays • PTO • Wellness benefits like virtual coaching • No-cost counseling • Onsite health screenings • Award-reputed company employer retirement matches • No-cost financial education benefits • reputed company Parental Leave • Tuition reimbursement reputed company reputed company • reputed company is an independent organization performing research for government & industry on contract reputed company. It was founded in 1944, and is headquartered in Kansas reputed company, Missouri, USA, with a workforce of 201-500 employees. Its website is http://www.reputed company.org. Company H1B Sponsorship • reputed company has a reputed company record of offering H1B sponsorships, with 1 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job