What You’ll Do:

The Senior Scientist, Analytical Development and Quality Control will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Senior Scientist will work directly with technical counterparts at vendor sites to implement the required product controls and ensure the integrity of data generated by our external partners. This role will also provide critical support for regulatory filings and ensure compliance with global regulatory standards.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs)
• Oversee analytical activities conducted by these CDMOs to ensure external partners fulfill technical needs and quality standards
• Perform detailed review and provide data integrity oversight of data generated at CDMOs
• Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes
• Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements
• Oversee stability programs to support product retest, shelf-life, and expiration dating
• Contribute to the preparation of data summaries and reports, and data review of regulatory submissions (INDs, NDAs, IMPDs)
• Ensure analytical methods and data meet regulatory requirements, generate data to justify specification limits, and assess trends in stability data
• Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations
• Participate in internal and external investigations of quality events (e.g., deviations, CAPAs, OOS, etc.)
• Work closely with Manufacturing and Quality Assurance teams to generate cGMP compliant data during product development and manufacturing
• Provide technical guidance and support to internal teams and external partners
• Oversee the preparation and review of technical documents, including protocols, reports, and SOPs

• Ensure data integrity and traceability in all analytical documentation

Required Qualifications:

• PhD with a minimum of 6 years, MS with a minimum of 10 years, or BS with a minimum of 12 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
• 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
• Proven effective communication and interpersonal skills
• Ability to work effectively in a fast-paced, collaborative environment

Preferred Qualifications:

• Experience with combination drug/device presentations is preferred
• Experience with establishing peptide drug substance analytical control strategy for various peptide synthesis modalities (linear SPPS, hybrid approaches, LPPS, and/or recombinant) is preferred

Education:

• PhD 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

What You’ll Do:

The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company’s integrated development plans and program timelines.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Support analytical development and QC activities related to characterization of peptide drug substances and drug products from early-stage clinical development through commercialization
• Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
• Support development of analytical methods that support Kailera’s product pipeline, including analytical transfers and troubleshooting in CDMO laboratories
• Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization
• Support authoring of relevant CMC sections to enable global regulatory filings
• Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
• Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
• Collaborate with cross-functional line functions to ensure CMC and program goals are met
• Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight

Required Qualifications:

• A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in all phases of innovative drug development and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.)
  • Or an advanced degree with 5+ years
• Knowledge of peptide chemistry is required
• Demonstrated project and cross-functional team participation
• Experience in authoring regulatory documents
• Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
• Experience with oversight of the analytical activities at CDMOs and/or CTLs
• Sound problem-solving skills with technically driven decision-making ability
• Effective written and verbal communication and interpersonal skills
• Innovative team-player with high energy for our dynamic company environment

Preferred Qualifications:

• Knowledge and experience in analytical development of peptide therapeutics (DS and DP)
• Knowledge and experience in analytical development of injectable products, and associated control strategies

Education:

• A Bachelors degree with 10+ years or an advanced degree with 5+ years of relevant experience
• Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.

Additional Information:

• This position requires some travel to domestic and international destinations
• This position requires working in environments where there may be specific gowning or dress code requirements