Director/Senior Director, Process Development
Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer and autoimmune diseases. Cue Biopharma is a high growth company and is listed on NASDAQ (CUE). Cue Biopharma is located in Cambridge, Massachusetts in the heart of the life sciences corridor.
Cue Biopharma is building a world-class team of highly motivated, dedicated scientists to help us advance our research and development programs. The Cue Biopharma culture is fast-paced and committed to scientific excellence, innovation, and teamwork.
In this newly introduced position at Cue Biopharma, the Director/Senior Director of Process Development will be tasked with improving and developing robust and scalable manufacturing processes, scientifically sound specifications, and associated analytical methods for our unique biologics. This role will be expected to support both internal research activities as well as work carried out through CMOs. Further, this individual, having demonstrated expertise and leadership in the field, will have the opportunity to build a small team to support upstream, downstream, and assay development activities. This position will report to the Vice President of Protein Therapeutics and will collaborate closely with the Head of CMC.
The successful candidate will have a demonstrated track record of success in the field of Process Development for biologics, as well as strong leadership skills. The candidate will have a passion for Process Development and a desire to work in a fast-paced, highly collaborative environment.
- Provide leadership within the organization for all Process Development related activities.
- Collaborate closely with our Head of CMC as well as our in-house protein production scientists.
- Optimize our current in-house processes to increase yields and reduce costs.
- Interface with our external drug substance and drug product manufacturers to provide expertise, support, and guidance.
- Oversee the design and execution of final product formulation, forced degradation, drug product manufacturing feasibility, and clinical in-use stability studies.
- Manage the biophysical characterization and comparison of products produced in house and at third party contract manufacturing sites.
- Establish specifications for in-house produced materials. Work with CMC to establish and justify specifications for drug substance and drug product produced at external sites to support IND enabling studies and clinical trials.
- Oversee the design and execution of biophysical characterization studies to evaluate the potential impact of process changes at external drug substance and drug product manufacturing sites on product quality.
- Support our clinical and pre-clinical programs through rigorous characterization of our candidate biologics.
- Apply your leadership and deep knowledge in the field to recruit and manage a small team to efficiently execute on all Process Development requirements.
- Maintain thorough and meticulous electronic notebook records.
- Ph.D. with 8+ years of industry experience or equivalent.
- Significant experience developing and troubleshooting biologics drug substance manufacturing processes.
- Experience with Fc fusion proteins strongly preferred, experience with monoclonal antibodies preferred.
- Successful demonstration in leading a Process Development team in the biologics field.
- Strong formulation expertise with the ability to design, manage and troubleshoot formulation development, drug product manufacturability and clinical in use stability studies.
- Strong team player with demonstrated track record of success in a matrixed, highly collaborative, fast-paced entrepreneurial environment.
- Excellent, organizational, oral, and written communication skills. Ability to lead through influence to negotiate effective solutions with other stakeholders within the company and with external partners.
- A motivated problem solver that excels when the odds look the most dire.
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