Drug Product Lead

This is a fully remote position, open to applicants in Germany.

📋 Description

• Provide technical leadership for cross-functional teams during the phases of drug development, commercial launch, or troubleshooting established processes and sites.

• Take the lead and represent the Drug Product (DP) team for a product that is in late-stage development or for a commercial product.

• Oversee site transfers to commercial DP manufacturing locations and manage process validation activities (demo/PPQ).

• Advocate for manufacturing, CCS, and formulation considerations within the PDS&T CMC team.

• Design, manage, and implement global initiatives aimed at enhancing CMC drug development and commercial support strategies.

• Draft project-specific documents, such as QTPP, formulation declaration, and control strategy documentation.

• Review and authorize GMP-compliant and regulatory documents (including IMPD, IND, CTD for clinical trials, and BLA, NDA, PAS for marketing authorization applications).

• Proactively communicate project strategies, significant issues, and risks to the PDS&T CMC team, functional leadership, and SMEs, while presenting complex technical subjects to both the development team and management.

⛳️ Requirements

• A degree in Pharmacy, Chemistry, Biochemistry, Biology, or an equivalent field, ideally with a PhD.

• Over 8 years of experience in relevant areas related to parenteral product development and/or commercial support.

• Demonstrated success in advancing intricate parenteral drug programs through late-stage development, showcasing recognized technical depth and scientific leadership.

• Strong experience in leading technology transfers from R&D to operations is highly desirable.

• Extensive experience in product development and commercial support during late development stages is preferred.

• Profound understanding of parenteral drug development, encompassing formulation, process development, manufacturability, and lifecycle considerations.

• Ability to manage multiple concurrent priorities in a dynamic, collaborative setting; strong expertise in global CMC drug development, strategic planning, and project execution.

• Experience in supporting the preparation of clinical and regulatory dossiers, as well as marketing authorization applications, including IMPD, IND, CTD, BLA, NDA, and PAS.

• Familiarity with a cGMP-regulated environment and a solid understanding of relevant international regulatory and quality requirements, especially in the US and EU.

• Exceptional leadership abilities with a proven track record of influencing and collaborating effectively within direct and cross-functional teams in a matrix organization.

🏝️ Benefits

• Competitive salary.

• Comprehensive onboarding experience.

• A dedicated mentor to support your career growth.

• Flexible working arrangements to foster a healthy work–life balance.

• Health management programs featuring comprehensive health and fitness initiatives.

• Employee social benefits.

• A wide array of career opportunities within an international organization.

• Attractive development prospects.

• A strong international network.