enGene · 3 days ago

Scientist - CMC Biological Assay Development

Waltham, MA

Full-time

Remote

Mid, Senior Level

6+ years exp

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BiotechnologyDiabetes

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Responsibilities

Strong technical expertise and experience in cell-based potency assays is a must; Familiarity with statistics software (e.g., JMP, PLA) and potency assay data analysis models is required

Design, execute and manage biological assay development, transfer, and validation for release/stability, in-process, extended characterization, and starting materials and intermediate testing

Execute and support development studies for process/product characterization and comparability studies

Draft, review, and approve SOPs, records/forms, protocols, specifications, and reports for transfer to internal and/or external QC lab(s)

Lead technical diligence efforts in support of the selection of CDMOs/CTOs for biological potency assay development/testing or other analytical testing as needed

Participate in cross-functional teams, including partner and CDMO interactions. Facilitate coordination of analytical activities with research, process development, manufacturing, quality, regulatory, and clinical supply functions as necessary

Support Quality Assurance on quality system and compliance activities, including audit functions, as needed

Assist in the preparation of CMC regulatory submissions, including providing data summaries and trend analysis

Adhere to internal and external regulatory (ICH, FDA, EMA, etc.) and GMP requirements to develop and establish analytical policy and process to facilitate department operations

Travel: Up to 25% – occasional international travel to partner or contractor facilities

Qualification

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Cell-Based Potency AssaysStatistics SoftwareBiological Assay DevelopmentAssay Data AnalysisSOPsQuality AssuranceRegulatory SubmissionsGMP RequirementsBiotechnology IndustryPharma IndustryAnalytical Methods

Required

BS in Biological Sciences or relevant field plus minimum of 6 years of experience in the biotechnology or pharma industry, with a primary focus on analytical development for biologic products

In-depth knowledge and experience in the biotechnology or pharma industry, with a primary focus on the method development, validation, and application of analytical methods for product development, characterization, and QC testing