Tanvex Biopharma is a biologic pharmaceutical product development and manufacturing organization aiming to provide high quality, value added capabilities to accelerate the introduction of biologic therapeutics to the global market. We currently have an exciting opportunity for a Scientist in our Analytical Characterization group at our location in San Diego, CA.
Highly motivated and self-driven scientist to work in a fast-paced, science-focused and collaborative environment for drug development to achieve the company's drug development target. Responsible for analytical method development and qualification for recombinant protein therapeutics analysis. Exercises strong working knowledge and hands-on experience in detailed physicochemical characterization of recombinant proteins including structure and modifications. Contributes to regulatory filings. Interacts with other functional groups on significant technical matters. Demonstrates leadership in scientific discussions and laboratory work.
- Perform analytical method development and implementation for detailed characterization of recombinant protein therapeutics with focus on:
- Intact mass, peptide mapping, disulfide linkage, post-translational modifications, charge and size variants.
- Independently design, implement, and conduct a series of scientific experiments using MS, HPLC, LC-MS, iCIEF, SEC-MALS, CE-SDS based analytical techniques to monitor product and process related substances in support of process development and characterization of pipeline projects.
- Work as a team member to characterize molecules, degradation pathways, and define critical quality attributes.
- Participate in method development, characterization, validation and transfer to QC laboratory and external collaborators.
- Apply relevant FDA and ICH guidelines to life-cycle management of analytical methods including method qualification/validation.
- Author SOPs, development reports, method qualification/validation protocols/reports and other technical reports.
- Participate in analytical similarity assessment studies.
- Contributes to CMC regulatory filings.
- Consistently demonstrate scientific leadership and creativity in the laboratory. Proactively develop and recommend new processes and technologies to increase understanding of complex biotherapeutics. Identify assay issues and suggest solutions.
- Stay current on new technology
- Collaborate with other functional groups for achievement of project objectives. May interact with external collaborators or CMOs/CROs.
- Effective communicator of ideas, project goals and results across functional groups.
- Interact with the management team on advanced technical matters.
- Demonstrate solid understanding of GMP/GLP, CMC, ICH requirements as well as regulatory filing requirements.
- BS or advanced degree in chemistry, chemical/biochemical engineering, biochemistry, or related scientific discipline,
- BS with 8 years, MS degree with 5 years, or PhD degree with 0-3 years of experience in analytical characterization within a pharmaceutical process development group.
Knowledge, skills, and abilities:
- Advanced knowledge in analytical method development in several key areas: HPLC (SEC, IEX, RPLC), LC-MS, CE-SDS, MALS, icIEF.
- Advanced understanding of protein macromolecular structure and function. Experience with PEGylated products and monoclonal antibodies is a plus.
- Proficient in programming, operating, and troubleshooting analytical systems including HPLCs, iCE3 (ProteinSimple), µDAWN, UT-rEX (Wyatt Technologies), and mass spectrometers (Thermo Orbitrap Fusion and Q-Exactive).
- Proficient in complex scientific data analysis with a variety of technical software. Strong capability in independent data interpretation and problem solving. May apply advanced modeling or statistical analysis tools where appropriate.
- Good working knowledge and experience with analytical method qualification and validation.
- Good working knowledge on GMP environment and late stage filings and regulatory requirements.
- Highly skilled communicator of ideas, project goals, and results.
- Strong written skills for technical documents. Capable of working effectively in teams and collaborating with other functional groups.
- Highly motivated, self-driven individual with demonstrated ability in critical thinking, problem solving and innovation
- Strong capability in multi-tasking and keeping timelines.
- Demonstrated leadership and collaboration skills.