Scientist, Analytical Development and Quality Control Specialist
4 days ago
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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