Senior Scientist, Analytical Development and Quality Control

Kailera Therapeutics, Inc.; Waltham (MA); On-site; USD 143,000 - 175,000; Full time

Benefits offered by this job

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Disability and life insurance

Annual bonus opportunities

Equity grants

Job summary

Kailera Therapeutics, Inc. in Waltham, MA seeks a Senior Scientist, Analytical Development and Quality Control to lead external partner-driven analytics for cGMP manufacturing and regulatory data support.

The role involves overseeing CDMOs, ensuring data integrity, method development and validation, and collaboration with Manufacturing and QA to enable compliant product development and release. The candidate will contribute to regulatory filings, maintain compliance with GMP, ICH, FDA and EMA

Qualifications

• PhD with ≥6 years, MS with ≥10 years, or BS with ≥12 years in analytical development and QC.
• Experience with peptides and/or small molecules in solid oral dosage forms.
• Experience managing outsourced activities with CDMOs.
• Strong analytical skills in HPLC, UPLC, MS, GC, dissolution, and spectroscopy.
• Knowledge of FDA/EMA and ICH guidelines for analytics.
• Effective written and verbal communication; works in fast-paced teams.

Responsibilities

• Participate in CDMO assessment and selection.
• Oversee analytical activities by CDMOs to ensure quality.
• Review data and ensure data integrity from CDMOs.
• Develop and implement analytical methods for drug substance/product.
• Oversee method validation aligned with regulatory requirements.
• Oversee stability programs for retest, shelf-life, and dating.
• Prepare data summaries/reports and review regulatory submissions.
• Ensure methods meet regulatory data integrity and traceability.
• Identify and investigate quality events (CAPAs, OOS).
• Collaborate with Manufacturing and QA to generate cGMP data.
• Provide technical guidance to internal teams and partners.
• Prepare and review protocols, reports, SOPs.

Skills

HPLC

UPLC

MS

GC

Dissolution

Spectroscopy

CDMO oversight

Analytical method development

Regulatory knowledge

Communication

Education

PhD in Analytical Chemistry or related

MS in Analytical Chemistry or related

BS in Analytical Chemistry or related

Job description

Senior Scientist, Analytical Development and Quality Control

Waltham, Massachusetts

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:

• D. 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/or small molecules in solid oral dosage forms
• Experience managing outsourced activities with CDMOs
• Strong expertise in analytical techniques such as HPLC, UPLC, MS, GC, dissolution, 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 development of discriminatory dissolution methods to support late-phase process changes, scale-up, and comparability for solid oral dosage forms
• Experience with developing small molecule drug substance impurity control strategies, including qualification, fate-and-purge, and specification setting

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.