Associate Scientist III, Protein Characterization
6 days ago
- Lead development, qualification, validation, and transfer of chromatographic and biophysical assays in some or all following categories: 1) Chromatography, including SEC, AEX, RP, and AF4 2) Light scattering applications, including DLS and MALS 3) Capillary electrophoresis, including CE-SDS, CE-LIF, and icIEF 4) Mass spectrometry applications, including intact LC-MS, peptide-mapping LC-MS/MS, and quantitative LC-MS/MS with MRM
- Lead conception, design, and execution of robustness testing
- Lead pilot forced degradation projects
- Lead transfer of processes, technology, and assays to/from internal and external labs
- Oversee assay development, testing, and troubleshooting at internal and external labs
- Evaluate, implement, and optimize new technology within Assay Development to support product extended characterization
- Present results, conclusions, and implications to cross-functional teams and senior management to support data-driven decision making
- Participate in external scientific meetings
- Author test procedures, standard test methods, SOPs, protocols, and technical reports
- Serve as a subject matter expert for chromatographic and biophysical assays
- Train and mentor junior personnel in technical areas
- Maintain a detailed awareness of industry regulatory guidance and standards for assay validation and performance
- Maintain current knowledge of advancing technologies and propose their applications to ongoing projects.
- Maintain excellent documentation of laboratory activities
- Perform routine lab maintenance
- Other responsibilities may be assigned as neededAbout you:
- Associate Scientist: Master's degree with 8+ years or Bachelor's degree with 10-12 years of relevant biotechnology industry experience.
- Experience in assay development is required
- Ability to read and extract information from published literature and internal reports is required
- Expertise is required in some or all of the following techniques: HPLC, AF4, CE, DLS, and MALS, LC-MS, and LC-MS/MS
- Experience in the qualification/validation of quantitative assays and knowledge of FDA requirements is strongly desired
- Broad knowledge of protein, cell, or nucleic acid assay methods and biochemistry with application to gene therapy is strongly desired
- Experience working with AAVs is a plus.
- Expertise in BLI, DSF, AUC, or BMI is desirable but not essential.
- Must be a self-starter, proactive, co-operative, and proficient at working both independently and in a small team environment
- Proven initiative and demonstrated accountability in a fast-paced environment with high degree of flexibility
- Detail oriented and with time management skills
- Excellent verbal and written communication skills
- Experience in presenting data through written reports and oral presentation; publication in a peer-reviewed journal or presentation at a conference is desired
- Proficiency with Empower, Dynamics, Astra, and other common analytical software desired
- Proficient with MS Office and other common office software About Us Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum's core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control. At Adverum, -Inclusion -and -Diversity -are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum -Community -to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation
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