Kailera Therapeutics, Inc.

Associate Director, Analytical Development and Quality Control

Remote-US · Director · Full-time

Sponsorship not specified$155k-$190kDetected 13 hours ago

StatisticsGMPLeadershipCommunicationProblem Solving

About the role

As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
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.

The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera's pipeline compounds.
Lead analytical development and support QC activities related to the development and commercialization of peptide drug substances..
Develop and maintain current knowledge in analytical methods and product and process control strategies supporting the peptide drug substance.
Through our external network, lead the development of analytical methods that support Kailera's product pipeline, including analytical transfers and troubleshooting in CDMO laboratories.
Provide input for developing and implementing analytical development strategies, including managing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
Collaborate with cross-functional line functions to ensure CMC and program goals are met.

Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy.
Experience in setting commercial specifications.
Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory requirements, and USP, EP, JP, and CHP requirements.
Strong understanding of all applicable ICH guidelines.
Experience with oversight of the analytical activities at CDMOs and/or CTLs.
Or an advanced degree with 5+ years

Knowledge and experience in analytical development of injectable products, and associated control strategies
Knowledge and experience in analytical development of small molecules and solid oral dosage forms.
Synthetic peptide manufacturing knowledge.
Experience with statistics and applying statistics to analytical chemistry.
Regulatory Inspection experience.
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:

$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.
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.
This range represents the company's good-faith estimate of the salary at the time of posting.

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 also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.

For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence.

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.
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.

tive 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-rel

This listing is sourced directly from Kailera Therapeutics, Inc.'s careers page and normalized into a canonical job model.