Symic Bio is a clinical stage biotherapeutics company developing novel compounds that target and affect the extracellular matrix (ECM), the noncellular component of tissue. The ECM plays a critical role in a wide variety of processes involved in acute and chronic indications. Symic Bio’s proprietary compounds function like proteoglycans, which are naturally occurring macromolecules that play important structural and regulatory functions in the ECM. Symic Bio currently has two clinical candidates, one in vascular injury and the other in osteoarthritis. In addition, Symic Bio has several preclinical programs in oncology, fibrosis and CNS disorders.
Reporting to the Director of Process Development, the Scientist II (Process Development) develops formulations, process unit operations and transfer drug substance/drug product processes to CMOs. This role will perform process characterization studies and support process validation activities at CMOs for commercialization of a novel class of biologics. This position is intimately involved in the Development and Manufacturing organization and actively participates in process troubleshooting and data analysis.
• Use formulation and process development concepts to develop Symic molecules towards commercialization.
• Develop and transfer required drug substance and drug product processes to support non-GMP and GMP manufacturing at CMOs.
• Conduct process characterization to support drug substances and drug product manufacturing and regulatory submissions.
• Develop and qualify analytical methods to support formulation and process development, stability studies and release activities.
• Perform routine sample analysis and trending of analytical data to support process development, drug substance/drug product stability and manufacturing activities.
• Support research teams to establish new formulations and processes for novel platform molecules.
• Solve complex problems in creative and effective ways.
• Be time-line driven and results-oriented
• Mentor and train research associates.
• Perform special assignments as needed.
• MS/PhD in biochemistry, pharmaceutical chemistry, chemical/biochemical engineering or related disciplines
• MS with 10+ years or PhD with 4+ years in-depth technical experience in formulation development, drug substance and drug product process development (Lyophilized and Parenteral) for conjugated peptides including biologics drugs.
• Strong background and experience in relevant unit operations including formulation, mixing, sterile filtration, aseptic processing, component processing, filling, lyophilization and visual inspection
• Hands-on experience with technology transfer of manufacturing process for both drug substance and drug product (Lyophilized and Parenteral) preferred
• Knowledge of cGMPs, regulatory agency guidelines, validation practices, and other relevant regulatory requirements
• Experience in biotech/biopharmaceutical industry with ability to work in a fast-paced, goal-oriented environment
• Solid knowledge of process engineering and process scale-up/scale-down design
• Proficiency in process characterization and process validation
• Must be scientifically knowledgeable, team-orientated, and passionate in biopharmaceutical development
• Excellent written and oral communication skills
• Must possess a positive, can-do attitude and demonstrate creative, problem-solving skills
Location: Emeryville, CA
Compensation: Competitive salary and equity as one of the early hires for the company