Description

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 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

Salary Range

$143,000—$175,000 USD

For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.

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.

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Senior Scientist, Analytical Development and Quality Control

Description

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