Pioneering Medicines: Director, Drug Substance Development bei Flagship Pioneering, Inc.
Flagship Pioneering, Inc. · Cambridge, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in Cambridge
What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?
Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments.
About Flagship Pioneering:
Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.
Position Overview:
We are seeking a highly experienced and visionary Director of Drug Substance Development to lead and expand our development capabilities across biologics and other modalities, including small molecules, peptides, and nucleic acids. The successful candidate will drive technical strategy, oversee process development activities, and ensure regulatory compliance while fostering innovation and high-performance team culture. This role is critical to advancing our pipeline from early research through IND and beyond.
Key Responsibilities:
- Leadership and Strategy:
- Define the strategy and lead the drug substance development team, fostering a culture of innovation and scientific excellence.
- Provide subject matter expertise in biologics process development, with strong cross-modality awareness.
- Collaborate with cross-functional teams, including Research, Development, Quality to align R&D activities. Represent the function in governance meetings and strategic collaborations.
- Process Development:
- Lead drug substance development (specifically biologics upstream and downstream) to establish scalable, robust, and cost-effective processes.
- Oversee process scale-up strategies and technology transfer to internal teams or external CDMO partners.
- Guide development of analytical methods to support process characterization and control.
- Project Management:
- Direct multiple development programs across stages, ensuring timely, high-quality delivery and pro-actively identifying and managing risks
- Manage resources, budgets, and timelines in collaboration with cross-functional teams.
- Oversee external partners (CDMOs/CROs) to ensure compliance with technical and quality standards.
- Regulatory and Compliance:
- Ensure all process development activities are in compliance with relevant regulatory guidelines (e.g., FDA, EMA) and internal quality standards.
- Contribute to the preparation of regulatory submissions, including INDs, BLAs, and other documentation.
- Support regulatory agency interactions with technical expertise.
- Innovation and Continuous Improvement:
- Stay abreast of the latest advancements in biologics process development, drive adoption new technologies and methodologies where appropriate.
- Implement continuous improvement to enhance yields, robustness, and efficiency.
- Team Development:
- Build, mentor, and retain a high-performing, multidisciplinary team..
- Promote a collaborative and inclusive work environment.
Qualifications:
- Ph.D. or master’s degree in chemical engineering, Biochemistry, Biotechnology, or a related field.
- Minimum of 10 years of experience in biologics upstream and downstream process development
- Proven success in scientific excellence, team leadership, and regulatory submissions.
- Strong understanding of current Good Manufacturing Practices (cGMP) and regulatory requirements for biology.
- Strong experience in management and collaboration with CDMOs
- Excellent leadership, communication, and interpersonal skills.
- Ability to work effectively in a fast-paced, dynamic environment.
Preferred Qualifications:
- Experience with small molecules, peptides, nucleic acids, cell and gene therapy products
- Understanding cell line development and process analytics
- Proficiency in process analytical technologies (PAT) and quality by design (QbD) principles.
About Flagship Pioneering:
Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.
