Drug Product Lead

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

📋 Description

• Offer technical guidance to interdisciplinary teams throughout the Drug Product development process.

• Lead and advocate for the Drug Product (DP) team in late-stage development and/or commercial product initiatives.

• Oversee Site Transfers to commercial DP manufacturing locations and manage process validation tasks (Demo/PPQ).

• Represent manufacturing, CCS, and Formulation domains within the PDS&T CMC Team.

• Design, oversee, and execute global initiatives aimed at enhancing biologics CMC drug product development and commercial support strategies.

• Generate 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 market application submissions).

• Actively communicate project strategies, critical issues, and risks to the PDS&T CMC Team, functional management, and subject matter experts.

⛳️ Requirements

• Degree in Pharmacy, Chemistry, Biochemistry, Biology, or a related field, preferably with a PhD.

• Minimum of 8 years of experience in relevant aspects of parenteral Drug Product Development and/or commercial support.

• Proven history of advancing complex parenteral drug product programs through late-stage development.

• Strong experience in leading the technology transfer process from R&D to Operations is highly preferred.

• Extensive experience in late-stage drug product development and commercial support is desirable.

• Comprehensive understanding of parenteral drug product development, including formulation, process development, manufacturability, and product lifecycle considerations.

• Capable of managing multiple concurrent priorities in a dynamic, collaborative setting.

• Significant expertise in global CMC drug development, strategic planning, and project execution.

• Experience in supporting clinical and regulatory dossier preparation and market authorization submissions, including IMPD, IND, CTD, BLA, NDA, and PAS.

• Background in a cGMP-regulated environment.

• Strong knowledge of relevant international regulatory and quality standards, particularly in the US and EU.

• Proven leadership abilities with a track record of influencing and collaborating effectively across both direct and cross-functional teams in a matrixed environment.

🏝️ Benefits

• Flexible work models promoting a healthy work-life balance.

• Competitive salary.

• Comprehensive onboarding process supported by a mentor.

• Corporate health management that includes extensive health and exercise programs.

• Company-provided social benefits.

• Diverse career opportunities within an international organization.

• Attractive development opportunities at a high level.

• Strong international network.