About JOINN Bio 

JOINN Biologics (JOINN Bio) is a Bay Area, California-based company that is committed to the advancement of biopharmaceutics through its premier contract development and manufacturing services for biologics and advanced therapies. JOINN Biologics aims to provide a complete range of services from early custom development to clinical manufacturing to our global clients. We will work closely with our partners and clients to further accelerate the development of high-quality biologics and deliver long-lasting value to the biopharmaceutical industry.  

Bioconjugation Process Development Scientist/Sr. Scientist 

The Bioconjugation Development Scientist/Sr. Scientist is responsible for leading and participating in bioconjugation and bioconjugate process development activities to support client-based projects in a CDMO environment all the way to GMP manufacturing operations. This includes conjugation development, downstream purification development, formulation development, bioconjugate analysis and scale-up activities support. The development Scientist will also be responsible for interfacing with clients and project managers, providing technical input to marketing and business development teams and management of direct reports within the bioconjugation process development team.  

Job Responsibilities 

• Leading and executing bioconjugation process development for client projects to successful completion which includes but is not limited to:  planning and cost analysis for projects, resource organization, process development for conjugation and downstream purification processes, documentation of process development activities, transfer of process for scale-up to manufacturing, on the floor support of manufacturing campaigns as needed, client interfacing for project updates and discussions. 
• Develop and optimize bioanalytical characterization tools to monitor critical quality attributes of products and impurity levels throughout the process development work (HPLC, LC-MS, cell based assays, ELISAs) and transfer of assays to Quality Control department for further development to support GxP manufacturing. 
• Provide technical support to business development team for client inquiries, proposal generation and case study/white paper or other marketing material generation 
• Authoring and reviewing relevant documentation including laboratory notebooks, process development reports, process descriptions, standard operating protocols, batch production records and other documents as needed. 
• Participate in and/or lead problem-solving or investigation activities and additional development activities related to deviations, CAPAs or other issues. 
• Coordinate with cross-functional teams like Manufacturing, Quality Assurance, Quality Control, Analytical Development and Supply Chain for coordination of activities required for successful development of processes or acquisition of materials needed for completion of production campaigns. 
• Perform regular literature review in the area of bioconjugation and downstream processing of bioconjugates as well as attend conferences or other meetings to continue building bioconjugation capabilities and learning new and evolving techniques. 
• Mentor and provide training to direct reports or junior colleagues and assess performance as needed. 
• Adhere to JOINN quality requirements, safety standards and general polices.  
• Maintain laboratory and equipment in an operational state by maintaining equipment/interfacing with vendors for servicing, maintaining inventories of consumables and reagents, ensuring proper safety procedures are followed at all times. 
• Others duties assigned.

• A PhD in biochemistry, molecular biology, chemical engineering, biology, chemistry, or related degree with a minimum of five (5) years industry experience; MS in biochemistry, molecular biology, chemical engineering, biology, chemistry, or related degree and a minimum of eight (8) years related experience; BS in and a minimum of ten (10) years related experience. Actual title will be considered based on relevant experience. 
• Experience working with Contract Development Manufacturing Organizations (CDMOs) or other fast-paced, client-based working environment 
• Demonstrated experience in bioconjugation screening, development and scale up including chemical and enzyme mediated conjugation techniques 
• Experience in conjugated biotherapeutic downstream process development and scale up including but not limited to: column and membrane chromatography processes, ultrafiltration and diafiltration processes, formulation and final filtration processes 
• Knowledge of cGMP manufacturing operations and GxP principles 
• Experience with bioanalytical techniques such as but not limited to HPLC, LC-MS, Capillary Electrophoresis, UV-spectrophotometry, cell based assays, ELISAs, etc… 
• Experience with large scale bioprocess equipment like AKTA Ready, AKTA Flux, Isolators, Mixing Systems, sealers, welders, etc. is a plus 
• Experience with risk assessments, process characterization and validation 
• Experience and working knowledge of technical transfer for GMP Bioconjugate manufacturing 
• Strong skills in planning of projects, organization of resources, troubleshooting of issues, time-management with multiple tasks, clear and concise communication with internal and cross-functional teams and presentation of data to clients and internal teams is a must 
• Strong documentation and technical writing skills related to laboratory notebooks, development reports, process descriptions, case studies, white papers, etc.
• Ability to work independently as well as in team environments and drive projects to completion in timely manners while maintaining flexibility and adapting to internal or client change requests 
• Willingness to work with highly potent cytotoxins utilized in generating bioconjugates such as antibody drug conjugates (ADCs) while adhering to strict safety requirements 

 JOINN Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age or veteran status.