Scientist, Analytical Development and Quality Control Specialist
3 hours ago
About the Role:
The Scientist, Analytical Development & Quality Control will be responsible for leading daily lab operations, supporting CMC process development, and collaborating with key stakeholders to define analytical capabilities required to manage Dyne's complex clinical supply chain.
Key Responsibilities:
- Develop, optimize, qualify, transfer, validate, and execute analytical methods for proteins, mAbs, drug conjugates using techniques pertinent to LC (SEC, RP, IEX), LCMS, ELISA, CE-SDS, icIEF, and other wet chemistry techniques.
- 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.
- Preparation and review of analytical test methods, standard work instructions, technical documents, protocols, reports, etc.
- Documentation of work in laboratory notebooks (paper-based) and logbooks according to organizational GDP policies.
- Maintenance, cleaning, calibration, troubleshooting, and repair of analytical instruments and equipment.
- Management of 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 similar related field required.
- A minimum of 3-5 years 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 one or more of 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.
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