Scientist II/Senior Scientist, Analytical Development (Heme)
Posted on Apr 6, 2021 by CRISPR Therapeutics AG
Oversee the development, optimization, and qualification/validation of robust assays for release and characterization of hematopoietic stem cell therapies:
Assays for lead sickle cell disease and ß-thalassemia gene-edited cell therapy (Potency, purity, impurities)
Provide expertise in stem cell therapies and hemoglobinopathies.
Provide leadership and guidance in designing and execution of method qualifications per ICH and regulatory guidelines.
Represent the analytical development team in cross-functional CMC meetings, and actively participate in strategy design, execution, data presentation and follow-up.
Form active collaborations with other teams within Analytical Development, Process development, Research and Quality teams.
Collaborate with external partners, CMOs and CTOs to lead or monitor outsourcing activities, manage timelines, and ensure deliverables.
Author technical reports, protocols, and analytical sections of regulatory filings for US, Europe, and ROW.
MS/Ph.D. in molecular biology, or related sciences such as cell biology, genetics, or immunology
Minimum 5-8 years (Ph.D.) for Scientist II or minimum 8-10 years (Ph.D.) for Senior Scientist or 15 years (MS) of biopharma industry experience with demonstrated track record of successfully developing various analytical methods required for characterization of stem cell products.
Strong knowledge of CRISPR gene editing, and analytical methods for cell and gene therapy products is required
Extensive knowledge and strong scientific background related to stem cell products underlying biology and emerging or existing knowledge in the field
Prior hands-on experience with qualifying and validating assays; understanding of ICH/FDA guidelines, and phase appropriate GMP requirements is highly preferred.
Prior experience of IND, BLA or equivalent regulatory filings is highly preferred.
Experiences with analytical or statistical software (eg, JMP, SoftMax Pro, Gen5 etc.), is highly desirable.
Experience of working with and managing external vendors/CROs is preferred.
Experience working with LIMS is preferred
Experience working with automation of analytics is preferred
Experience managing direct reports is preferred
Strong writing, reviewing, and presentation skills is required
Ability to multi-task in a fast-paced environment with changing priorities.
Highly motivated, detail oriented with good problem-solving ability.