Full-Time

Associate Director

Product Quality

Updated on 3/14/2025

Kymera Therapeutics

Kymera Therapeutics

201-500 employees

Develops targeted protein degradation therapies

No salary listed

Senior, Expert

Belmont, MA, USA

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • Bachelor of Science in Life Sciences
  • 8+ years of experience in pharmaceutical manufacturing or laboratory settings
  • At least 4 years in a GMP quality assurance role
  • Experience in a small-molecule manufacturing environment is preferred
  • Experience in Quality oversight of outsourced GMP manufacturing activities
  • Excellent communication and interpersonal skills
  • Experience working in a CMC team setting as a Quality representative
  • Strong problem-solving ability to evaluate quality matters and make risk-based decisions
Responsibilities
  • Provide quality oversight of contract organizations associated with the manufacturing and distribution of clinical APIs, Drug Products, and Finished Goods
  • Collaborate with manufacturing and distribution colleagues to review manufacturing batch records, protocols, reports, and specifications, and perform disposition of critical intermediates, drug substances/drug products, and finished goods
  • Partner closely with CMC analytical colleagues to review test methods, SOPs, analytical data summaries, validation and stability protocols, and technical reports; oversee specification control and shelf life management
  • Ensure that product quality-related issues, including deviations/OOSs/OOTs and product complaints, are appropriately investigated and resolved
  • 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
  • Present quality assessments to the Material Review Board and Quality Management Review Board
Desired Qualifications
  • Experience in a small-molecule manufacturing environment is preferred

Kymera Therapeutics develops treatments by targeting and breaking down specific proteins that contribute to diseases, particularly cancer and immune disorders. Their main technology, the Pegasus Platform, enables them to identify these harmful proteins and create drug candidates aimed at effectively treating various conditions. Unlike many competitors, Kymera focuses on protein degradation, which can lead to more effective therapies for unmet medical needs. The company's goal is to advance next-generation medicines through strategic partnerships, such as their collaboration with Sanofi, and to generate revenue through research partnerships and potential drug sales.

Company Size

201-500

Company Stage

IPO

Headquarters

Cambridge, Massachusetts

Founded

2016

Simplify Jobs

Simplify's Take

What believers are saying

  • Kymera raised $225M and $275M in public offerings to fund R&D.
  • Partnership with Neosphere advances molecular glue target discovery.
  • HSBC's investment shows confidence in Kymera's protein degradation technology.

What critics are saying

  • Competition from Arvinas and Nurix may impact Kymera's market share.
  • Potential clinical trial delays could affect drug development timelines.
  • Reliance on partnerships like Sanofi poses revenue and R&D risks.

What makes Kymera Therapeutics unique

  • Kymera's Pegasus Platform enables precise targeting of disease-causing proteins.
  • The company focuses on developing orally administered therapies like KT-294.
  • Kymera's strategic partnership with Sanofi enhances its drug development capabilities.

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Benefits

Hybrid Work Options

Growth & Insights and Company News

Headcount

6 month growth

-3%

1 year growth

-3%

2 year growth

0%
Yahoo Finance
Aug 20th, 2024
Kymera Therapeutics Announces Pricing of $225 Million Public Offering

WATERTOWN, Mass., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced the pricing of its underwritten public offering of $225 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. Kymera is selling 2,002,313 shares of common stock

Endpoints News
Aug 20th, 2024
Kymera seeks to raise $225M; Adcendo, Multitude's new ADC deal

Kymera Therapeutics aims to raise $225M: The public offering will be...

TXBN
Aug 20th, 2024
Kymera seeks to raise $225M; Adcendo, Multitude's new ADC deal

Kymera Therapeutics aims to raise $225M: The public offering will be used to fund Kymera's pipeline, and some funds could be used for small acquisitions or in-licensing deals.

BioWorld
May 14th, 2024
Neosphere Biotechnologies and Kymera Therapeutics partner to advance molecular glue target discovery

Neosphere Biotechnologies and Kymera Therapeutics partner to advance molecular glue target discovery.

Enid News & Eagle
May 2nd, 2024
Kymera Therapeutics Announces First Quarter 2024 Financial Results and Provides a Business Update

Kymera unveiled its first-in-class oral TYK2 degrader, KT-294, at its Immunology R&D Day in January 2024.