New · posted Oct 15
Kailera · Biotechnology
Senior Scientist, Analytical Development and Quality Control
- Waltham, MA
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
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 need
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
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
Preferred Qualificationsnice to have
- 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
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.
- 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
Pay and benefits
$143,000 – $175,000 a year
Employer provided$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.
Comprehensive health coverage
Flexible time off
401(k) match
Tuition reimbursement
Annual bonus and equity grants
Monthly wellness stipend
Where you'll work
Waltham, MAHybridOpen in Maps (opens in a new tab)
More jobs in Waltham, MAEqual opportunity, accessibility and legal noticesKailera's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 67% above the US median for Quality Control roles at this level.
This roleEmployer provided
Senior & Principal roles in Massachusetts11 roles publishing pay
Senior & Principal roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $143,000 | — | $175,000 |
| Massachusetts (middle half) | $85,750 | $97,500 | $111,000 |
| All US (middle half) | $78,500 | $95,000 | $108,500 |
This role: Kailera's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Kailera's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods13
- Collaboration and leadership5
- GMP and compliance3
- Documentation and SOPs3
- Validation and qualification2
- Data and digital systems2
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
Company hiring pulse
Kailera on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 2
- Locations
By discipline
- Regulatory4 80%
- Quality1 20%
By level
- Director4 80%
- Senior & Principal1 20%
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Senior Scientist, Analytical Development and Quality Control at Kailera
Open until filled. $143K–$175K a year, employer provided.