At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing hard scientific problems with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines.
We are seeking a dedicated Senior NPI Scientist who will serve as a crucial link between our R&D teams and manufacturing environments. You will shepherd our work from the lab to the factory floor, overseeing the implementation of reagent quality programs and bolstering reagent production. Your specialty will lie in crafting methods for the production and testing of our innovative processes, technologies, and products. As an integral member of our team, you will be responsible for new product scale-up, process optimization, technology transfer, and process validation activities.
You will draft production procedures and product specifications for antibody reagents, and review and resolve issues to facilitate the smooth transfer of upstream process technology to our manufacturing facilities.Our ideal candidate brings in-depth understanding of antibody structure and function, and significant hands-on experience in antibody conjugation, and in designing and optimizing protein expression and purification strategies for complex antibodies or antibody fragments. This position is located in San Carlos, CA and requires full-time onsite presence. Responsibilities:
Ensuring that all processes developed are robust, scalable, and commercially viable.
Resolving issues to facilitate seamless transfer of upstream process technology to our manufacturing team or outsourced CMO partners.
Improving documentation including SOPs, batch logs, and technical documentation to promote ongoing improvement.
Collaborating with the R&D team to design, develop and implement procedures to enhance manufacturing processes and meet regulatory requirements.
Assisting process development in creating scalable processes that improve product yield and reduce manufacturing costs.
Serving as the point of entry for all new reagent formulations to internal and external reagent production. Work with the R&D teams to implement any formulation/process changes that will improve manufacturability and scalability.
Developing strategies to integrate complex formulation processes, such as protein and Ab conjugation, from the R&D team into a production environment.
Creating materials to document finalized processes and facilitate training for manufacturing associates.
Supporting continuous production of complex formulations to meet experimental requirements.
Collaborating with the Analytical Team to create formulation specifications and test methods for ongoing quality inspection of internally and externally produced reagents.
Requirements:
PhD complemented by a minimum of 4 years of industry experience.
Extensive experience with chemistry, particularly orthogonal bioconjugation chemistry, chromatography, and analytical techniques (HPLC, MS, LC/MS, NMR).
Proven experience in the synthesis and evaluation of reagents for use in antibody, protein, or peptide conjugates.
Hands-on experience in conjugation, purification, and characterization of conjugates.
Proficiency in protein conjugation, protein manipulation, and protein storage/handling.
Demonstrated success in implementing reagent qualification and quality programs, as well as transitioning products from development to high-volume production environments.
Ability to make formulation and process adjustments to optimize the performance of a reagent to its required specification.
Demonstrated ability to define root causes and corrective actions for reagent quality/qualification issues.
Excellent interpersonal and communication skills with a demonstrated ability to train others to execute SOPs and processes successfully.
Proficiency in Excel and project scheduling tools (Smartsheet, Microsoft Project, etc.).
Willingness to work hands-on in a laboratory and production environment and support the production of reagents when additional production capacity is required.
Demonstrated project management skills with an ability to meet project timelines and deliverables.
Nautilus Team Culture
We are curious go-getters: this is a team of life-long learners who aren’t afraid to tackle the big challenges and we embrace the journey.
We are detail-oriented: we do great science by working smart & with diligence where we learn from our trials and mistakes.
We are easy to work with: we want our workplace to be one where everyone can share their perspective and be treated with respect and kindness.
Compensation Range: $128K - $157K
