Associate Director, Analytical Development and Quality Control - Boston
17 hours ago
Job 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 Associate Director, Analytical Development and Quality Control will support analytical development and Quality Control operations for clinical development and commercialization of Kailera's pipeline compounds.
The individual will provide technical expertise and will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with the company's integrated development plans and program timelines.
Required location:
Waltham, MA (hub-based, onsite 3-4 days per week)
Responsibilities
Support analytical development and QC activities related to characterization of drug substances and drug products from early-stage clinical development through commercialization
Maintain current knowledge in analytical methods and control strategies supporting a variety of molecule platforms and dosage forms
Oversee and provide scientific leadership on QC testing for DS/DP at vendors, ensuring cGMP compliance, data integrity, and timely delivery of analytical results
Direct investigations including OOS/OOT, deviations, and CAPAs, and provide strong analytical rationale
Design and manage stability programs (accelerated, long-term, bracketing/matrixing) supporting early and late clinical phases
Interpret stability trends and establish shelf-life/retest periods consistent with ICH guidelines and peptide behavior
Support comparability assessments for process changes, analytical method updates, or site transfers
Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making
Participate in cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
Author and review CMC sections of IND/IMPD and NDA submissions and address regulatory questions
Prepare for audits/inspections and represent analytical and QC functions to regulatory authorities
Lead, mentor, and develop analytical and QC staff while driving continuous improvement and phase-appropriate analytical strategies
Required Qualifications
10+ years of experience, or 5+ 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, dissolution, along with extractables and leachable analysis
Knowledge of drug development activities with respect to cGMP, quality systems, ICH guidelines, global regulatory requirements, and USP, EP, JP, and CHP requirements
Hands-on experience supporting early- and late-stage CMC development, stability programs, and specification setting
Proven experience leading OOS/OOT investigations, deviations, CAPAs, and change controls
Strong track record of working with CROs/CMOs and managing external analytical/testing activities
Excellent technical writing skills for analytical reports and regulatory submissions (IND/IMPD, NDA/BLA)
Demonstrated leadership ability with experience mentoring and developing scientific staff
Strong communication, cross-functional collaboration, and project-management skills
Innovative team-player with high energy for our dynamic company environment
Preferred Qualifications
Prior peptide product development including familiarity with peptide manufacturing, characterization, formulation, and stability experience is preferred
Education
A bachelor's degree with 10+ years or an advanced degree with 5+ years of relevant experience
Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field
Additional Information
This position requires some travel to domestic and international destinations
This position requires working in environments where there may be specific gowning or dress code requirements
Salary Range
$155,000—$190,000 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 InformationKailera 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-VerifyKailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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