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Kailera Therapeutics · 21 hours ago

Senior Director, Drug Substance Development and Manufacturing (Peptide)

Waltham, Massachusetts

Full-time

Hybrid

Director/Executive

$210K/yr - $270K/yr

10+ years exp

Kailera is committed to developing therapies that empower individuals to transform their lives and enhance their health. They are seeking a Senior Director, Drug Substance Development and Manufacturing to lead outsourced manufacturing operations and drive technical excellence across the manufacturing lifecycle.

BiotechnologyPharmaceuticalTherapeutics

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 excellence

Establish and drive continuous improvement initiatives focused on enhancing manufacturing efficiency, enabling cost reduction, and establishing strategic redundancies across the CDMO network

Define 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 strategy

Manage and enforce CDMO performance against key project timelines, deliverables, and costs, holding partners accountable to agreed-upon expectations

Lead the negotiation and execution of complex technical agreements and work orders with CDMO partners, ensuring clarity and successful delivery of manufacturing campaigns

Oversee budget planning and forecasting for all outsourced drug substance manufacturing activities

Serve as the strategic lead for drug substance activities, driving seamless collaboration across Analytical Development, Formulation, Quality Assurance, and Regulatory Affairs to ensure cohesive program execution

Oversee 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 submissions

Direct 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 stakeholders

Qualification

Peptide drug developmentSynthetic manufacturing techniquesRecombinant manufacturing techniquesRegulatory knowledgeProcess validationTechnical transfersProcess optimizationDetail orientationCross-functional collaborationCritical thinkingCommunication skills

Required

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 approaches

Hands-on experience with the synthesis and manufacturing of peptides is mandatory

Demonstrated track record in managing clinical-scale supply, process characterization and optimization, technical transfers, and process validation activities

Sound technical skills in applying scientific principles to complex process design, implementation, and successful technology transfer

Regulatory 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 plans

Demonstrated ability to ensure accountability of self and others, coupled with strong detail-orientation to proactively identify and mitigate risks and issues

Ability 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 milestones

Proven success in building and maintaining strong, effective relationships with Contract Development and Manufacturing Organizations (CDMOs) to drive performance and manage risk

Demonstrated ability to lead and contribute effectively to cross-functional teams to advance complex projects to completion

Excellent verbal and written communication skills with a proven ability to build internal and external relationships and influence senior stakeholders