Senior Scientist, Process Chemistry
We are currently seeking a Senior Scientist, Process Chemistry to support Cidara’s development and manufacturing activities for cloudbreak® anti-viral conjugate products. Reporting to the Senior Director, Pharmaceutical Sciences, the role will be responsible for supporting the development, implementation, and tech transfer for manufacturing protein conjugate and protein fusion new chemical entities and/or other bioconjugation, purification, and pre-formulation processes in both pre-clinical and clinical environments.
- Evaluates, optimizes, and implements novel conjugation techniques, developing scalable and robust conjugation processes by synthesizing, purifying, and analyzing protein or antibody conjugates using associated analytical methodologies (e.g. HPLC and UV-Vis spectroscopy).
- Supports technical transfer, scale-up, manufacturing, and regulatory activities through collaboration with Quality, Manufacturing, Analytical, Discovery chemistry and other internal and external stakeholders.
- Conducts experiments including conjugation reactions, ultrafiltration/diafiltration, column chromatography, filtration operations and pre-formulation studies. Accurately documents procedures and results in laboratory notebook.
- Performs data analysis, prepares results summaries and may present experimental results and data summaries as required.
- Provides material and documentation to support global regulatory submissions
- Optimizes processes in a phase appropriate manner for cost, quality and efficiency
- Preparation of technical transfer documentation for newly developed processes and technologies.
- Involved in the oversight of upstream and downstream GMP manufacturing as needed to support overall manufacturing programs.
- Supports the authoring and/or review of GMP documentation such as specifications, batch records, and deviation reports, as required.
- Maintains the high professional standards for laboratory safety, data integrity and record keeping.
- Maintain excellent grasp of current scientific literature and understanding of the state of the art for bioconjugation chemistry, purification, and screening strategies.
- MS or Ph.D. in biochemistry, chemistry, protein chemistry or related discipline with 5+ years of industry technical experience or a BS and 10+ years of appropriate technical experience.
- Possess excellent problem-solving skills and demonstrate a thorough understanding of protein chemistry, protein handling, purification and characterization.
- Extensive experience with common bioconjugation reactions, techniques and proven track record in the field
- Comfortable with routine use of analytical techniques required to support process development such as (but not limited to) HPLC, LC/MS, FPLC (affinity purification, size exclusion chromatography, hydrophobic interaction chromatography, etc.), SDS-PAGE and UV-VIS spectroscopy
- Working knowledge of relevant GMP/ICH and FDA (along with other global regulatory authority) regulations/practices
- Excellent written and verbal communication skills
- Ability to work independently and as a member of a multi-functional team
- Working knowledge of biologics production and/or specific experience with end to end production of antibody drug conjugates would be a plus
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.
Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company