Principal Scientist/Senior Scientist, CMC Analytical Development
Menlo Park, CA, USA
Posted on Wednesday, October 26, 2022
Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
The Principal Scientist/Senior Scientist of CMC Analytical Development will be responsible for the Analytical Development activities for methods to be used for potency, mechanism of action studies, product characterization and release testing of early- and late-stage cell therapy programs. Additional responsibilities will include creating CMC analytical content for BLA submission.
- Author BLA content for commercialization programs and commercial launch preparation, including comprehensive set of specifications, method development and validation, potency and mechanism of action studies, analytical comparability studies, product stability studies
- Drive method transfer projects between the sending and receiving labs, including establishing method transfer overall plan, generation of transfer protocols, execution of transfer testing and generation of reports.
- Lead method validation of robust analytical methods for release and stability testing of cell therapy products including writing and review of protocols and reports.
- Develop and optimize immunoassays and cell-based functional assays for cell therapy products
- Perform extended characterization of product, characterization of biological activity, potency and mechanism of action studies
- Interpret experimental results and perform data analysis using appropriate software.
- Serve as subject matter expert for one or more analytical technologies such as flow cytometry, bioassays, cell counting, particle testing, potency methods
- Prepare and present high-quality data summaries and project progress updates to stakeholders and at cross-functional team meetings
- Author and review protocols, technical reports, method SOPs and regulatory submissions.
- Collaborate effectively with cross-functional teams including Process Development, Manufacturing, QC and Quality Assurance.
- PhD in Pharmaceutical Sciences, Biology, Immunology, Cell Biology, with 5-7 years relevant industry experience. Candidates with B.S./M.S. may also be considered with demonstrated leadership track record in Analytical development and drug product process development
- History with commercialization projects and successful track record of BLA or IND authorship is highly desired
- Experience in immune functional assays in cell therapy and/or biologics analytical development and/or quality control laboratories
- Must have substantial expertise with flow cytometry and cell-based assay technologies.
- Knowledge and broad understanding of Quality Control and cGMP requirements as they apply to the Biopharmaceutical industry. Good understanding of relevant USP methodologies and ICH guidelines
- Experience working with CMOs, CROs, contract service providers and consultant contributors
- Experience in cGMP cell therapy and/or biological product manufacturing, preferably with emphasis on immunological systems, cell therapy, gene therapy, and individualized patient therapies is a plus
- Experience working with and leading cross functional teams such as CMC teams and clinical development teams
- Outstanding written and verbal communication skills
- Self-starter with great interpersonal skills and strong planning/tracking skills
- Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.
Who we are
We are scientists, engineers and business operators working with urgency to develop new therapies for patients faced with no or extremely limited options today.
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all patients who need them.
We strive to do things right. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not”, and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
We invite you to join us and bring your unique perspective and experiences to our team.
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