Location: Bend, OR
Rezolute, Inc. is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with metabolic and orphan diseases. The company’s pipeline includes three programs comprised of two clinical stage compounds and one late pre-clinical stage platform. Rezolute recently announced a $25M raise with a $45M potential and has opened offices in Redwood City, CA (Headquarters) and Bend, OR (Technical). We are now seeking highly qualified and dynamic individuals to join and help grow our emerging biopharma company. More information can be found at www.rezolutebio.com
Rezolute is a growing and dynamic organization seeking an Upstream Bioprocess Engineer to join our Bend Oregon based CMC team. This position is responsible for evaluating, defining, creating and supporting processes for the manufacture of protein therapeutics. The individual will work with the internal CMC team as well as co-development partners to collaborate and manage external CROs, CDMOs and CMOs for the development, characterization and manufacture of Drug Substance. This position will oversee the creation and implementation of manufacturing processes as well as the transfer of processes to clinical and commercial stage outsource partners. Fundamental to the role is the ability to solve difficult bioreactor process related challenges.
- Develop and scale-up cell culture manufacturing processes; demonstrate the ability to quantitatively define and model upstream biologics manufacturing technologies
- Act as subject matter expert on upstream process, equipment and unit operations; prefer demonstrated knowledge and proficiency in downstream process development and scaleup
- Utilize analytical technologies to monitor and define manufacturing processes as well as drug substance attributes; review analytical data packages for accuracy and completeness
- Lead upstream (and downstream) process characterization, qualification and validation activities to support global registration of biologics products
- Manage technical relationships with CROs, CDMOs and CMOs responsible for early and late stage manufacturers of drug substance.
- De-risk, troubleshoot and optimize manufacturing processes
- Act as Person in Plant (PIP) with oversight of process development and manufacturing activities at external partner and CMO sites
- Author CMC related documentation in the support of clinical advancement
- Work closely with Quality Assurance and Operations management to prepare, review or edit cGMP batch records, CMC regulatory and Quality documents to include change controls, deviations, investigation, standard operating procedures, and forms as necessary to advance the pipeline or a specific program
- A minimum of a Bachelor’s level degree in chemical engineering; advanced degree in related field preferred.
- A minimum of 5 – 10 years of upstream bioreactor development, qualification, validation and commercialization experience for monoclonal antibodies required
- Extensive knowledge in bio-chemical analytical characterization of proteins, mAbs, fragments and biologics; understanding of or exposure to biological analytical test methods such as SE-HPLC, CE-SDS, cIEX, ELISA, and HILIC
- Experience using statistical design and analysis programs to include JMP
- Extensive problem-solving capabilities
- Experience with cGMPs and Validation practices
- Superb communication, analytical, and organizational skills
- The ability to work in an agile and diverse team environment
- Excellent written and verbal skills; attention to detail; ability to seamlessly multi-task across multiple projects and programs
- The ability to travel overnight and overseas, approximately 10% - 20% total time
- Interest and desire to support broader responsibilities within a CMC team to include project management, supply chain coordination, analytical data review and due diligence
- Good humor, agility in learning and action, and a team player
Interested and qualified candidates should send resume to firstname.lastname@example.org, to the attention of Melissa Quinn.