Senior/Principal Scientist – Product Development
About ANGIOCRINE BIOSCIENCE, Inc
Angiocrine Bioscience Inc. (AB) is a privately held, San Diego, CA based clinical-stage biopharmaceutical company with proprietary technologies consisting of a line of human engineered endothelial cells (E-CEL) intended for hemato-oncology and regenerative medicine applications. AB has two IND clearances, one on-going Phase 1b study and plans to start two to four Phase 1b studies in 2019. The AB team is united and fueled by its passion and sense of urgency to bring new, breakthrough engineered cell therapies to patients suffering from dire, often life-threatening medical conditions.
Position Role & Responsibilities:
The main role of Senior/Principal Scientist, Product Development is to be a hands-on (wet-lab) leader in advancing our pre-clinical engineered cell product candidates intended for local implantation. This role involves not only assessing our various engineered cells pre-clinically but also the use of our engineered cells with various bio-scaffolds and novel formulations. We estimate 80% activities of this role to occur in our state-of-the-art wet lab located in the Sorrento Valley area of San Diego biotech hub.
A secondary role is to assist the Director, Product Development, in CMC issues of our clinical candidates.
AB is founded and funded by entrepreneurs. Consequently, we expect the successful candidate to act as one of the entrepreneurs/owners of the company by being proactive (a can-do-attitude), creative, and committed to the goal of launching novel cellular therapies into the clinic. The successful candidate thinks through problems and provides options for solutions with a sense-of-urgency; once a decision is made, this person promptly and proactively conducts studies, analyzes data, presents results and recommends next steps to the AB R&D Executive Team, which includes the CEO and COO. In return for shouldering complete accountability for AB’s pre-clinical product development, the successful candidate will be an important part of decision making (unlike more mature or larger companies) and have a unique and major opportunity to put his/her personal stamp on the growth and destiny of AB.
- Plans and conducts development research of engineered cells for new local implantation indications where engineered cells are combined with various bio-scaffolds or suspended in novel formulations.
- Analyzes and presents data in a timely, organized fashion as data becomes available.
- Designs and personally conducts pre-clinical product development studies (both in vitro and in vivo) that are suitable for IND inclusion and conforms with Non-Clinical and CMC requirements of the US FDA.
- Builds budgets and timelines with Project Management of all local implantation pre-clinical product development studies (in-house or out-sourced).
- Directs and plays key role as lead scientists for outsourced (pre-clinical CRO or academic group) pre-clinical studies of local implantation (with scaffolds or new formulation) of AB engineered cell lines.
- Works collaboratively with fellow AB team members, especially with the AB Research Team and the AB Project Management Team.
- Completed PhD and post-doc in relevant area (i.e., implantation cell therapy, preferentially with bio-scaffolds).
- Minimum of 5 years (beyond post-doc) as scientist/senior scientist or hands-on wet-lab leader involving research and/or product development of cell therapy product.
- Demonstrates skills and experience involving wet-lab cell therapy translational research (e.g., various cell culture techniques, cell sorting, flow cytometry, qPCR, fluorescent microscopy, antibody assays, intra-cellular signaling detection).
- Demonstrates successful track record and expertise in novel assay development of cell therapy candidates from therapeutic candidate declaration (i.e. completion of basic research) to IND submission.
- Demonstrates expertise in analyzing data and hands-on writing of study reports applicable to inclusion of FDA IND submissions.
- Demonstrates basic knowledge of Non-Clinical and CMC requirements for IND submission as a pre-clinical product development professional (rather than at the level of a Non-Clinical and/or CMC regulatory expert).
- Lives in or will relocate to San Diego County area (i.e., the position is wet-lab based in our R&D facilities in northern suburbs of San Diego).
- Ideal candidate would have demonstrated knowledge and have conducted wet-lab in vitro and in vivo (animal) studies using cell therapy candidates (destined for IND/BLA) and bio-scaffolds (destined for IDE/510K/PMA route), either together or separately. Preference given to candidate with more experience with cell biology versus a bio-matrix engineering, although both would be ideal.
- Enjoys a fast-paced, semi-virtual corporate environment where evolutionary changes are a constant and where proactive ‘can do’ attitude, sense of urgency and friendly personalities are prized.
- Must demonstrate passion and burning desire to proactively contribute to building a cutting-edge young and rapidly growing engineered cell therapy company.
- Exudes ‘extra-mile’ attitude (e.g., does the job whenever needed, helps out colleague eagerly even though ‘not in job description’) and ‘owner’ mentality (e.g., as if spending your own money).
- While not required, any expertise in immunology (particularly with regard to implantation of allogeneic cell sources) is highly desirable.
- This position is based in San Diego, CA.
- Angiocrine is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.