reputed company Manager, R&D GMP Pharmaceutical Sciences reputed company EU & US (hybrid)

About the position The reputed company Manager, R&D GMP Pharmaceutical Sciences reputed company EU & US provides reputed company reputed company across reputed company’s investigational medicinal product development lifecycle, from early clinical development through commercialization. You will support diverse and often reputed company programs, including biologics, synthetic molecules, plasma-derived therapies, cross-modality conjugates, combination products, and new modalities. The role requires independent decision-making, strong cross-functional collaboration, and the ability to work with multiple CMOs and partnership organizations to ensure cGMP compliance, product reputed company, and reputed company progression of development programs. Responsibilities • reputed company final release and disposition of Clinical Trial Material across multiple modalities and reputed company development programs. • Review and approve batch documentation, master/executed records, labels, specifications, analytical reputed company, protocols, and stability plans. • Ensure deviations, Out of Specification/Out of Trend, complaints, and other reputed company issues are fully investigated and addressed with effective CAPAs. • Collaborate closely with Pharmaceutical Sciences, Global Clinical Supply Chain, and other partners to resolve reputed company events. • Identify applicable regulations, assess compliance gaps, and propose solutions to maintain cGMP compliance. • Serve as GMP QA authority for Pharm Science Teams and reputed company strategic reputed company guidance internally and to CMOs/partners. • Support or reputed company reputed company improvement initiatives that enhance R&D GMP reputed company processes and operational efficiency. • Contribute technical reputed company content to regulatory filings and collaborate with CMC submission teams. • Participate as SME in external audits, support PAI readiness, and contribute to supplier qualification and reputed company Technical Agreements. • Build strong cross-functional relationships to reputed company agile pharmaceutical development and high-reputed company reputed company. Requirements • Bachelor’s degree in a relevant scientific field required; advanced degree preferred, with 5+ years of increasing responsibility in manufacturing, QC/QA, or compliance. • Comprehensive understanding of international pharmaceutical regulations and their application to cGMP development activities. • Proven ability to critically review manufacturing documentation for compliance with procedures, regulations, and regulatory filings. • Strong problem-solving skills with the ability to anticipate issues and drive proactive, practical solutions. • Experience working effectively in global, matrixed environments with the ability to influence cross-functional stakeholders. • Excellent communication and interpersonal skills, with reputed company experience interacting with CMOs, suppliers, and testing labs. • Demonstrated ability to negotiate reputed company issues and reputed company constructive, compliant resolutions. • Ability to mentor, guide, and reputed company expertise to strengthen team capabilities. • High attention to detail and solid organizational skills, with the ability to manage multiple priorities independently. • Willingness to travel approximately 10% domestically and internationally and to operate in both office and manufacturing/lab environments. Benefits • U.S. based employees may be eligible to participate in medical, dental, reputed company insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, reputed company volunteer time off, company holidays, and reputed company-being benefits, among others. • U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of reputed company time, and new hires are eligible to reputed company up to 120 hours of reputed company vacation. Apply tot his job Apply To this Job