New · posted Oct 20
Kailera · Pharmaceuticals
Director, Analytical Development and Quality Control
- Remote, US
- Remote
- Full-time
- Director
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
- 10+ years of experience, or 8+ with advanced degree, 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.)
- Strong expertise in analytical techniques HPLC/UPLC, LC–MS, SE-HPLC, CCIT, device testing, etc.
- Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
- Strong track record of working with CROs/CMOs and managing external analytical development and QC activities
- Demonstrated leadership ability with experience mentoring and developing staff
- Strong communication, cross-functional collaboration, and project-management skills
- Innovative team-player with high energy for our dynamic company environment
Education
- A bachelor’s degree with 10+ years or an advanced degree with 8+ years of relevant experience
- Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field
Preferred Qualificationsnice to have
- Prior experience supporting development of peptide sterile injectable/combination drug products
- Experience supporting commercial products
- Knowledge of combination product testing and control strategy is a plus
What you'll do
The Director, Analytical Development and Quality Control will provide strategic and technical leadership for the analytical development, qualification, validation, and lifecycle management of analytical methods, and overall analytical control strategy supporting the development and commercialization of sterile parenteral drug products, in support of Kailera’s pipeline. This role is responsible for leading all activities to enable successful regulatory submissions, approval, and product launch.
The successful candidate will bring progressive experience in pharmaceutical or biopharmaceutical analytical development, including demonstrated experience supporting an NDA for a parenteral drug product. The role requires a strong understanding of analytical chemistry, method development and validation, drug product characterization, stability programs, specifications, and regulatory CMC requirements, together with the ability to translate complex analytical data into sound technical and regulatory strategies.
The Director will work cross-functionally with other Technical Operations functions, Quality Control, Quality Assurance, Regulatory Affairs, Manufacturing, and external contract development and manufacturing organizations (CDMOs) and contract testing laboratories. This leader will establish analytical strategies, oversee external laboratory execution, ensure scientific and regulatory rigor, and drive analytical readiness to support clinical and regulatory milestones, NDA approval, and commercial supply.
Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based, onsite at a hub 1 week every other month).
- Lead analytical development, control strategy, and lifecycle management for sterile injectable/parenteral products from development through commercialization, including method development, validation, transfer, QC implementation, and commercial support.
- Define and execute analytical CMC strategies, regulatory submissions, and control frameworks, including NDA Module 3 content, analytical data packages, specifications, characterization, validation, stability, and commercial release requirements.
- Ensure scientifically sound, regulatory-compliant analytical programs by leading technical issue resolution, risk management, resource planning, agency interactions, and compliance with FDA, ICH, and pharmacopeial expectations.
- Provide analytical leadership for product characterization, stability, microbiological strategies, quality attributes, commercial manufacturing support, and investigations related to analytical trends, deviations, and product quality issues.
- Establish and maintain robust analytical methods through risk-based qualification, validation, lifecycle management, continuous improvement, troubleshooting, performance monitoring, revalidation, and enhancement of method robustness and efficiency.
- Lead stability and specification strategies across the product lifecycle, ensuring analytical data support shelf life, storage conditions, regulatory commitments, product release, and commercialization objectives.
- Integrate analytical, formulation, process, and manufacturing knowledge to support technology transfer, comparability assessments, change management, and oversight of external analytical laboratories and partners.
Pay and benefits
$192,000 – $235,000 a year
Employer provided$192,000—$235,000 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
Monthly wellness stipend
Annual bonus and equity grants
Equal 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 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in the US44 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $192,000 | — | $235,000 |
| All US (middle half) | $191,750 | $213,750 | $242,750 |
This role: Kailera's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 86 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Kailera's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods14
- Collaboration and leadership9
- Regulatory submissions6
- Validation and qualification5
- Quality systems and risk3
- GMP and compliance2
- Documentation and SOPs1
- Investigations and CAPA1
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
- 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
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
Kailera on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 3
- Locations
By discipline
- Regulatory6 86%
- Quality1 14%
By level
- Director5 71%
- VP & Executive1 14%
- Senior & Principal1 14%
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Director, Analytical Development and Quality Control at Kailera
Open until filled. $192K–$235K a year, employer provided.