Kymera Therapeutics

Director, Product Quality

Watertown, MA · Director

Sponsorship not specified$195k-$275kDetected 35 days ago

GMPFDA RegulatoryCommunicationProblem Solving

About the role

Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics.
For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
Our goals are shared, our decisions data-driven and our camaraderie genuine. - BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

Responsibilities

Collaborate with manufacturing and distribution colleagues to (i) review manufacturing batch records, protocols, reports, and specifications, and (ii) perform disposition of critical intermediates, drug substances/drug products, and finished goods.
Partner closely with CMC analytical colleagues to (i) review test methods, SOPs, analytical data summaries, validation and stability protocols, and technical reports (ii) oversee specification control and shelf life management.
Collaborate cross-functionally and develop strong relationships with internal and external partners.
Support the preparation and review of regulatory filing submissions (IND/IMPD/NDA)
Help develop and implement phase-appropriate SOPs and policies. Ensure compliance with relevant regulatory requirements such as FDA, EMA, and ICH guidelines.
Manage the qualification and performance monitoring of external GMP suppliers and maintain Quality Agreements with them.
Develop and track quality metrics to measure performance and identify trends.
Provide support for late-stage manufacturing and commercialization readiness activities.
Work independently and manage multiple projects within the established timelines and objectives.

Nice to have

8 + years of experience in pharmaceutical manufacturing or laboratory settings, including at least 4 years in a GMP quality assurance role.
Experience in a small-molecule manufacturing environment is preferred.

Skills

Excellent communication and interpersonal skills.
Strong problem-solving ability to evaluate quality matters and make risk-based decisions.

Compensation

Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
The anticipated base salary range for this role is $195,000- $275,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate's depth of experience and the capabilities they bring to the position.

Company info

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
How we work:
PIONEER: We are courageous, resilient and rigorous in our mission to improve patients' lives through our revolutionary degrader medicines.
COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives.
Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions.
Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years.
BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.
How you'll make an impact:
The Director will act as a Quality subject matter expert for Good Manufacturing Practices (GMP) activities.
The individual will be responsible for material disposition; will provide Quality oversight for technical transfers, stability assessments, manufacturing, analytical and distribution activities performed at external suppliers.
In addition, the individual will ensure compliance with regulations and Kymera policies and procedures.

Equal opportunity

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.
All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
Compensation
Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.

Visa & Work Authorization

veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class

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