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Lead Scientist, Quality Control Chemistry

2 months ago


Woburn, Massachusetts, United States ComforceHealth Full time

Position Title: Lead Scientist, Quality Control Chemistry

Company: ComforceHealth

Position Overview:

ComforceHealth is seeking a highly skilled Lead Scientist in Quality Control Chemistry to join our dynamic team. This role is essential for ensuring the integrity and reliability of our analytical testing processes.

Key Responsibilities:

  • Oversee and troubleshoot LC-MS instrumentation while guiding method lifecycle activities for LC-MS testing to ensure compliance with GMP standards.
  • Support the gene therapy program by engaging in technical transfers, method qualifications, validations, and routine GMP testing of AAV vector analytical methods.
  • Collaborate with external laboratories and contribute to the design of study protocols, as well as review study reports and provide IND support.
  • Work cross-functionally with teams in Quality Control, Analytical Development, Quality Assurance, and Manufacturing to enhance operational efficiency.
  • Conduct data trending, investigate assay invalidations, and manage quality events including deviations and CAPAs.
  • Lead routine laboratory operations, ensuring cleanliness, inventory management, and compliance with standard operating procedures.
  • Prepare and present technical reports and documentation for both internal and external stakeholders.
  • Stay updated on advancements in biophysical and analytical instrumentation relevant to AAV characterization.

Qualifications:

  • Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, Biophysics, or a related field with a minimum of 4 years of relevant experience in R&D or cGMP environments.
  • Proven experience in a cGMP Quality Control laboratory within the pharmaceutical or biopharmaceutical sectors is preferred.
  • Familiarity with HPLC/UPLC techniques for analyzing biological materials is advantageous.
  • Strong collaboration, communication, and organizational skills are essential for success in this role.
  • Ability to work independently while effectively managing multiple tasks in a fast-paced environment.

Compensation and Benefits:

ComforceHealth offers a competitive pay range and a comprehensive benefits package, including medical and pharmacy coverage, dental and vision insurance, 401(k), and various paid leave options.

About ComforceHealth:

ComforceHealth is dedicated to providing innovative solutions in the healthcare sector, employing a diverse team of professionals committed to excellence and integrity in all aspects of our operations.