Associate Director Analytical Development and Quality Control

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:

The Associate Director will oversee outsourced analytical development and quality control activities supporting manufacturing, quality release, and stability studies of drug substances and drug products. This role will also provide critical support for regulatory filings and ensure compliance with global regulatory standards, as well as develop internal operational and quality procedures to fulfil later stage and commercial vendor oversight responsibilities.

Responsibilities:

• Outsourced Management:
• Identity and participate in the selection of Contract Development and Manufacturing Organizations (CDMOs).
• Oversee analytical activities conducted by these CDMOs to ensure external partners meet project timelines and quality standards.
• Analytical Methods Development:
• Identify the critical product attributes required for each product, ensure appropriate methods are developed, and then implement the methods for testing of drug substance and drug product.
• Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements.
• Oversee stability programs to support product shelf-life and expiration dating.
• Regulatory Support:
• Contribute to the preparation of regulatory submissions (INDs, NDAs, IMPDs).
• Ensure analytical methods and data meet regulatory requirements, that specifications limits are justified, and assess the trends in stability data.
• Compliance & Quality Assurance:
• Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations.
• Participate in audits and inspections as the analytical subject matter expert if needed.
• Cross-Functional Collaboration:
• Work closely with Manufacturing, Quality Assurance, Regulatory Affairs, and Clinical Development teams.
• Provide technical guidance and support to internal teams and external partners.
• Documentation & Reporting:
• Oversee the preparation and review of technical documents, including protocols, reports, and SOPs.
• Ensure data integrity and traceability in all analytical documentation.

Qualifications:

• Education:
• Ph.D. or MS degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field, or a BS degree with a commensurate amount of directly applicable industry experience.
• Experience:
• Ph.D. with a minimum of 8 years or MS with a minimum of 10 years of experience in analytical development and quality control within the pharmaceutical or biotech industry.
• Proven experience with peptides and small molecules in both injectable and solid oral dosage forms.
• Experience managing outsourced activities with CDMOs.
• Skills:
• Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, and spectroscopic methods.
• Knowledge of regulatory requirements (FDA, EMA) and ICH guidelines related to analytical development.
• Effective communication and interpersonal skills.
• Ability to work effectively in a fast-paced, collaborative environment.

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:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.