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Kailera Therapeutics · 1 day ago

Senior Scientist, Analytical Development and Quality Control

San Diego, California

Full-time

Hybrid

Mid, Senior Level

$115K/yr - $140K/yr

6+ years exp

Kailera is committed to developing therapies that empower individuals to enhance their health, fostering a collaborative and inclusive workplace. The Senior Scientist in Analytical Development and Quality Control will oversee analytical activities conducted by external partners, ensuring compliance with regulatory standards while supporting quality control and product integrity.

BiotechnologyPharmaceuticalTherapeutics

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

Qualification

Analytical developmentQuality controlHPLCRegulatory requirementsCDMO managementPeptide expertiseEffective communicationInterpersonal skillsCollaborative environment

Required

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

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