Associate Director Drug Substance Development and Manufacturing

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 Associate Director, Drug Substance Development and Manufacturing who will support drug substance manufacturing including process development and improvement, clinical supply manufacturing, and commercial preparedness. This position requires an experienced individual with a working understanding of drug development throughout clinical development and requires a high level of collaboration both with internal teams and external partners. The Associate Director reports to the Vice President, Drug Substance Development and Manufacturing.

Responsibilities:

• Support the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing at CDMO partners, ensuring strategic alignment and operational excellence.
• Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs to ensure seamless project progression.
• Support continuous improvement initiatives to enhance manufacturing efficiency, reduce costs, enable strategic redundancies, and improve product quality from both technical and strategic sourcing perspectives.
• Draft technical reports and presentations to communicate results and progress to internal and external stakeholders.
• Support preparation of drug substance modules in regulatory dossiers and collaborate with regulatory affairs to support regulatory submissions.
• Develop a working understanding of industry trends, technological advancements, green manufacturing processes, and regulatory changes to ensure our manufacturing processes are competitive and compliant.

Qualifications:

• Degree in Chemistry, Chemical Engineering, or related life sciences field.
• 5+ years of relevant experience in drug substance development and manufacturing for clinical-scale supply, process characterization and optimization, technical transfers, and process validation. Experience with synthesis of peptides and small molecules is preferred.
• Experience in a small company or start-up environment is preferred.
• Solid knowledge of cGMPs, Quality systems, and global regulatory requirements.
• Sound skills applying scientific principles to process design, implementation, and tech transfer.
• Experience building strong relationships with contract manufacturing organizations.
• Experience with drafting of regulatory submissions (IND, NDA, MAA, etc.).
• Ability to think critically with a keen sense of urgency, entrepreneurial spirit, and demonstrated problem solving abilities.
• Solution-based critical thinking skills focused on successful execution of drug development plans.
• Ability to ensure accountability of oneself and others.
• Detail-oriented with ability to identify and mitigate risks/issues.
• Ability to contribute to multiple projects simultaneously; assess inter-relationships across multiple disciplines in product development; identify gaps that may impact critical milestones.
• Demonstrated ability to contribute to cross-functional teams to advance complex projects to completion.
• Excellent verbal and written communication skills with an ability to build relationships internally and externally.
• Excellent computer skills (e.g. Word, Excel, PowerPoint, Teams).
• Travel: Up to 20% (domestic and international)

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION: 

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify:

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