Scientist Analytical Development

Profile

Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs.

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Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 85 employees and is located in Waltham, Massachusetts.

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Summary

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The Scientist reports to the Director of Pharmaceutical Sciences and Technology (PST) and supports analytical and quality control activities to progress molecules from early development through to clinical trials and product licensure.  The scientist is accountable for analytical development and characterization of Visterra’s pipeline molecules.  The scientist will work very closely with internal QA, MFG, and Regulatory teams as well as with Contract Test and Manufacturing partners.

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This is a full-time position based in Visterra’s facility in Waltham, MA.

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Responsibilities

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• Build an effective partnership with Quality Assurance, Supply Chain, Regulatory Affairs, Translational and Nonclinical Development teams.
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• Lead method validation/qualification activities, authoring and/or reviewing protocols, and coordinating testing with Contract Research Organizations (CROs).
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• Lead the stability program and provide timely stability updates for regulatory documents.
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• Perform stability data trending analyses, assign expiry dates.
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• Generate standard operating procedures for the characterization of biologics for use at Visterra.  This role will also train lab members and manage the transfer of methods to Contract Manufacturing Organizations (CMOs).
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• Identify and stay current with new analytical technologies and methods for the characterization of biologics.
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• Perform characterization and degradation studies on lead candidates, critically assess findings and share results with cross-functional teams.
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• Manage timelines and milestones for analytical assessment of lead candidates and ensure a smooth transfer to CMOs and Contract Test Organizations (CTOs).
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• Provide subject matter expertise support in determining the proper fit for Contract Test Organizations (CTOs) for assay transfer, develop protocols or assay qualification and validation, and review and approve data.
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• Prepare presentations for external partners and internal meetings and represent analytical and CMC issues.
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• Provide analytical support for investigations at CTOs and CMOs, generate hypothesis, critically review results to support deviations, Out Of Specification (OOS) results, Corrective And Preventative Actions (CAPAs).
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• Review analytical development reports, assay and process validation reports and other technical documents for technical correctness and regulatory compliance.
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• Travel to CTO sites may be required as needed to assist with site audits (up to 5% travel).
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• Other duties and responsibilities as required by departmental and business needs.
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Requirements

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• A minimum of seven (7) years of industry or related professional analytical experience.
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• A PhD degree in analytical chemistry, biochemistry or a related analytical scientific discipline with 1-5 years of experience, a BS with 7 years or an MS with 5 years’ experience.
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• Hands-on experience with some of the following analytical methods: ELISAs, cell-based potency assays, HPLC, UPLC, CE-SDS, SDS-Page, protein purification, CEX, icIEF, and Mass Spectrometry.
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• Experience with statistical and analytical software, such as SPSS, JMP, Excel, SAS, Chemstation, SoftMax, PRISM, or Empower.
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• Strong interest in innovative strategies for analysis and control of new modalities of biologics.
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• Experience with trouble-shooting assays, creative problem-solving, method transfer and mentoring junior team members.
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• Familiarity with Quality guidance documents (ICH, CFR, USP, general guidance).
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• The ability to work in a fast-paced dynamic environment with changing priorities.
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• Demonstrated forward thinking skills, with the flexibility to support multiple development programs simultaneously.
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• Skilled in managing cross functional relationships and collaboration as a team member.
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• Experience with writing reports, generating cross-functional presentations, working with external teams and maintaining timelines.
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• Excellent written and verbal communication skills
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• Strong time management and organizational skills, attention to accuracy and detail, and the ability and willingness to multi-task as needed.
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• Limited travel (< 5%) may be required to attend conferences and industry events, in addition to the limited travel mentioned above.
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Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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