Codagenix Inc. is a clinical-stage synthetic biology company that uses software to recode the genomes of viruses, constructing live-attenuated vaccines or viruses to prevent viral infections or treat solid tumors. Codagenix’s recoded vaccine candidates are a perfect antigenic match to the target virus and induce a robust immune response to all viral antigens. Our nimble platform allows us to turn a virus into a potential prophylactic vaccine.
Summary Description:
We are seeking a candidate with laboratory experience for a full time, on site, Associate Scientist position in Process Development. This includes design and development of manufacturing processes for viral production, purification, scale-up and final formulation studies. This position will work closely with both the Discovery and R&D teams to develop and optimize manufacturing operations and testing of new technologies. We are looking for a proactive, resourceful, and goal-oriented team member who is able to work effectively both independently and as part of a matrixed project team.
Responsibilities Include:
- Participate as a member of a cross-functional team for the development and optimization of production processes and formulation of drug product.
- Participate in bench-scale and pilot-scale experiments for process and formulation development leading to manufacturing of cGMP drug substance and drug product. Includes purification methods, UF/DF, excipient screening, compatibility, accelerated stability, etc.
- Technology Transfer of developed manufacturing processes to CDMO for scale-up and clinical manufacturing.
- Execute laboratory assays to assess process development and formulation experiments (ELISA, gels, residual impurity analyses, PCR).
- Document experiments, key activities and results in scientific notebooks according to company policy.
- Assist in the preparation of media, stock solutions and reagents used in process development experiments.
- Analyze data, summarize conclusions and plans for further action, and present results to team members and management in a clear and timely manner.
- Maintain knowledge of scientific trends and industry processes through readings, conferences, and seminars; reviewing literature to enhance or improve manufacturing procedures and methods.
Required Qualifications:
- Requires B.S. or M.S. in a scientific discipline (Microbiology, Biochemistry, Cell Biology, Biochemical Engineering or related discipline); Minimum 5+ years of industry experience.
- Experience working with Viruses (Live Attenuated Viral vaccines). Hands-on experience with various purification, filtration and formulation equipment and techniques preferred.
- Full competency in aseptic and sterile techniques; GXP recommended.
- Demonstrated ability to independently design and analyze experiments.
- Ability to prioritize, manage time efficiently, and implement creative solutions to meet program needs in a faced environment.
- Strong communication skills and with the ability to collaborate with colleagues in a cross-functional, fast paced team environment.
- Must work well in teams with other scientists.
- Excellent problem-solving skills including critical and analytical thinking.
- Comfort with statistical analyses and related software (Excel, GraphPad, JMP, Prism).
Preferred Qualifications:
- High degree of independence, proactivity, and a strong sense of accountability.
- Experience using Design of Experiments (DOE) and Quality by Design (QbD) methodologies.
- Experience and/or working knowledge of cell culture and harvest/recovery equipment (centrifugation, depth filtration, and ultrafiltration).
- Technology transfer and process fit experience.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Note: Candidates for this position must be currently authorized to work in the United States on a full-time basis, and Codagenix will not sponsor applicants for work visas. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
