Bioprocess Development Scientist
Diadem Biotherapeutics Inc. is seeking a Bioprocess Development Scientist to join a cross-disciplinary team developing novel, immunotherapeutic biologics for chronic inflammation and autoimmune diseases. This position will be part of a dynamic group responsible for bioprocess development, scale up, fundamental characterization of a novel biologic and tech transfer to a manufacturing partner. The ideal candidate is a detail oriented, team-player who can prioritize responsibilities, multi-task and remain flexible with changing needs and evolving responsibilities in start-up environment. The candidate would have the opportunity to participate in community activities and biotech business development curriculum at the IndieBio accelerator/incubator in San Francisco. The ideal candidate is willing to relocate to Diadem’s Los Angeles headquarters in early 2020. The position title and compensation level will be commensurate with the candidate’s qualifications and experience.
Responsibilities and Duties
Define and develop scalable downstream purification processes for mammalian cell derived proteins and extracellular vesicles.
Develop analytical methods to quantify yield, identity, purity and physiochemical properties at various stages of the manufacturing process
Develop analytical methods to assess the effectiveness and robustness of purification processes.
Produce purified biologics for animal studies, diagnostic tests, reference standards, and stability studies.
Maintain accurate laboratory notebook and relevant documentation.
Author and review technical reports and SOPs for equipment and process.
Troubleshoot and maintain analytical and process equipment.
Identify and evaluate new technologies for process and analysis.
Present results in both internal and external forums.
Prepare study reports and presentations for group meetings, conferences, publications and regulatory filings.
Support tech transfer of new products and processes to ensure smooth transition from process development into cGMP manufacturing.
Qualifications and Skills
M.S. degree in Biophysics, Biochemistry, Chemical Engineering, Bioengineering, Bioprocessing or related technical field or B.S with significant industry experience in purifying and analyzing proteins and or extracellular vesicles.
An excellent working knowledge of biologics development process is essential.
Working knowledge of FDA regulations and the goals and guidelines of GMP practices is essential.
A sound understanding of protein biochemistry and recombinant protein expression in mammalian hosts relevant to downstream purification.
Ability to design, develop and execute product identity and purity assays including ELISA, SDS-PAGE, SE-HPLC, LAL, host cell-DNA, host cell protein.
Strong theoretical background and direct hands-on experience with downstream processing unit operations such as preparative chromatography, centrifugation, homogenization, micro filtration, ultra-filtration, sterile filtration, etc.
Proficient at protein purification using affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA FPLC systems.
Experimental design and data analysis capabilities including Design of Experiments (DOE).
Understanding of engineering issues involved in scale up.
Strong oral presentation and communication skills.
Organized, collaborative, team-player attitude.
Direct experience in the pre-clinical development of I-O therapies such as checkpoint antibodies would be a plus.