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Senior Director, Drug Substance Development and Manufacturing
4 weeks ago
Senior Director, Drug Substance Development and Manufacturing (Peptide)At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera's mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.What You'll Do:We are seeking an accomplished and strategic Senior Director, Drug Substance Development and Manufacturing to lead and oversee all outsourced drug substance manufacturing operations.Reporting directly to the Vice President, Drug Substance Development and Manufacturing, this key leadership role is accountable for driving technical excellence across the manufacturing lifecycle, including process development and continuous improvement, clinical supply manufacturing, and ensuring commercial preparedness and validation.The ideal candidate is an experienced leader with a deep technical understanding of peptide drug development and significant experience with both synthetic and recombinant manufacturing techniques for peptides and/or peptide fragments. Success in this role requires a high degree of collaborative leadership, effectively managing and driving complex programs through internal cross-functional teams and external Contract Development and Manufacturing Organizations (CDMOs).Required location: Waltham, MA or San Diego, CA (onsite or hybrid 3-4 days per week).Responsibilities:In collaboration with senior leadership, direct and lead all process development, scale-up, technology transfer, and validation activities for peptide drug substance manufacturing across all Contract Development and Manufacturing Organizations (CDMOs), ensuring strategic alignment and operational excellenceEstablish and drive continuous improvement initiatives focused on enhancing manufacturing efficiency, enabling cost reduction, and establishing strategic redundancies across the CDMO networkDefine the long-term vision for manufacturing by maintaining a deep knowledge of industry trends, technological advancements, green manufacturing processes, and emerging regulatory changes to ensure a competitive and compliant strategyManage and enforce CDMO performance against key project timelines, deliverables, and costs, holding partners accountable to agreed-upon expectationsLead the negotiation and execution of complex technical agreements and work orders with CDMO partners, ensuring clarity and successful delivery of manufacturing campaignsOversee budget planning and forecasting for all outsourced drug substance manufacturing activitiesServe as the strategic lead for drug substance activities, driving seamless collaboration across Analytical Development, Formulation, Quality Assurance, and Regulatory Affairs to ensure cohesive program executionOversee the preparation and completion of drug substance modules (e.g., Module 3) for all regulatory dossiers (e.g., IND, NDA), partnering closely with Regulatory Affairs to ensure timely and compliant global submissionsDirect the preparation and final authorship of high-quality technical reports, executive summaries, and presentations to effectively communicate results and progress to internal leadership and external stakeholdersRequired Qualifications:Minimum of 10+ years of progressive, relevant experience in drug substance development and manufacturing. This must include deep expertise in both synthetic and recombinant manufacturing approachesHands-on experience with the synthesis and manufacturing of peptides is mandatoryDemonstrated track record in managing clinical-scale supply, process characterization and optimization, technical transfers, and process validation activitiesSound technical skills in applying scientific principles to complex process design, implementation, and successful technology transferRegulatory Knowledge: Solid knowledge of current Good Manufacturing Practices (cGMPs), Quality systems, and global regulatory requirements (e.g., FDA, EMA)Proven experience with the drafting, review, and authoring of CMC sections for major global regulatory submissions (e.g., IND, NDA, MAA)Exceptional solution-based critical thinking skills and the ability to operate with a keen sense of urgency and an entrepreneurial spirit, focused on the successful execution of complex drug development plansDemonstrated ability to ensure accountability of self and others, coupled with strong detail-orientation to proactively identify and mitigate risks and issuesAbility to strategically contribute to and manage multiple concurrent projects; assess complex inter-relationships across various product development disciplines; and identify critical gaps that may impact key milestonesProven success in building and maintaining strong, effective relationships with Contract Development and Manufacturing Organizations (CDMOs) to drive performance and manage riskDemonstrated ability to lead and contribute effectively to cross-functional teams to advance complex projects to completionExcellent verbal and written communication skills with a proven ability to build internal and external relationships and influence senior stakeholdersPreferred Qualifications:Experience in a small company or start-up environment is strongly preferredEducation:Advanced degree in Chemistry, Chemical Engineering, or a related life sciences fieldSalary Range: $210,000 - $270,000 USD
