Scientist, Analytical Development and Quality Control Specialist

4 days ago


Waltham, Massachusetts, United States Atlas Venture Full time
Job Title: Scientist, Analytical Development and Quality Control Specialist

Job Summary:

We are seeking a highly skilled Scientist, Analytical Development and Quality Control Specialist to join our team at Dyne Therapeutics. As a key member of our analytical development team, you will be responsible for developing, optimizing, and qualifying analytical methods for proteins, monoclonal antibodies, and drug conjugates.

Responsibilities:

  • Develop and optimize analytical methods for proteins, monoclonal antibodies, and drug conjugates using techniques such as LC, LCMS, ELISA, CE-SDS, and icIEF.
  • Lead and manage daily lab operations for analytical testing and support CMC process development.
  • Execute and test development and non-GMP stability samples in-house.
  • Partner with research to support early-stage development and adapt methodology to be suitable for GMP testing.
  • Prepare and review analytical test methods, standard work instructions, technical documents, protocols, reports, and other documentation.
  • Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
  • Manage work carried out by third-party analytical and metrology service providers.
  • Adhere to organizational EHS policies and maintain work areas in a safe and clean environment.
  • Peer review of analytical data.

Requirements:

  • Bachelor's or master's degree in biology, biochemistry, chemistry, or a related field.
  • A minimum of 3-5 years of experience in analytical development and/or quality control, preferably in a clinical-stage biopharmaceutical company.
  • Hands-on experience and knowledge of a variety of analytical techniques, including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, and mass spectroscopy.
  • Strong chemistry and analytical background with experience in general, compendial, and product-specific analytical tools and practices pertinent to monoclonal antibodies, small molecules, oligonucleotides, and/or mab-conjugates.
  • Experience working with CDMOs and external QC vendors.
  • Familiarity with cGMP/ICH/FDA/EU regulations.
  • Ability to challenge current processes, practices, and strategy and uncover alternative approaches, solutions, or methods.
  • Excellent interpersonal, organizational, negotiation, and communication skills; a team member that can work collaboratively with colleagues across functions.

About Dyne Therapeutics:

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.

What We Offer:

We offer a dynamic and collaborative work environment, competitive compensation and benefits package, and opportunities for professional growth and development.

How to Apply:

Please submit your application, including your resume and cover letter, to [insert contact information].



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