Scientist 1

Salary Range: 110000 to 130000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Executes assigned work with full understanding of and ability to apply principles, theories, and concepts in specialized areas of responsibility. 
• Uses current scientific literature with the technical capability to select methods and techniques for obtaining solutions within broadly defined practices and procedures. 
• Produces proteins using mammalian cell culture to support lead generation/optimization and preclinical studies. 
• Produces proteins using mammalian cell cultures under cGMP standards and with cGMP standards and regulations in consideration for production of clinical trial materials. 
• Participates in technical transfer of upstream manufacturing processes from clients and between Development and Manufacturing groups. 
• Leads client projects including the planning, execution, and conclusions. 
• Exercises technical discretion in design, execution and interpretation of manufacturing and production that contributes to project goals. 
• Provides detailed observations, analyzes data, interprets results and develops scientifically-sound solutions. 
• Acts as a Subject Matter Expert (SME) to train others in areas of expertise.  Assists and offers guidance to the Process Development group and Manufacturing group as necessary to train on correlated processes. 
• Oversees production schedules, materials, equipment and manpower requirements. 
• Maintains records to comply with regulatory requirements and assists with in-process testing. 
• Operates and ensures appropriate maintenance of production equipment as it relates upstream production activities. 
• Troubleshoots processing problems, bringing unusual problems (e.g., potential deviations) to the attention of the supervisor. 
• Initiates deviations, assess product quality impact, and propose Corrective and Preventative Actions (CAPA), as needed. 
• Sets up and performs scale down models to assist with process validations and manufacturing investigations, providing analysis as needed. 
• Prepares technical reports, summaries, protocols, batch records and performs quantitative analyses.  
• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. 
• Organizes own daily workload schedule and relevant resource requirements. 
• Operates with minimal supervision on complex systems and equipment. 
• Mentors and leads the work of junior personnel in the field.  Provides training to new personnel in specific technical processes. 
• Supports project teams on multiple projects simultaneously. 
• Represents departmental activities as needed, including project teams, task forces, audits and business or technical meetings with outside groups. 
• Develops effective working relationships with both internal and external partners. 
• Operates to the highest ethical and moral standards. 
• Complies with Abzena's policies and procedures. 
• Communicates effectively with clients, supervisors, colleagues and staff. 
• Participates effectively as a team player in all aspects of Abzena's business. 
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.  
• Performs other duties as assigned. 

Qualifications

• BS, MS, or PhD degree in applicable scientific field. 
• Minimum of 9 years directly related experience with a BS degree; Minimum of 6 years directly related experience with an MS degree; Minimum of 0 years’ experience with a PhD degree. 
• Knowledge and skill of mammalian cell cultures and concepts of cell metabolism, protein production, and characterization. 
• Knowledge and skill in relation to cell culture process steps including cell banking, thaw and expansion, and production (batch-fed and perfusion). 
• Knowledge of designing of experiments for increase productivity in relation to operation of multivariate experiments using the Sartorius platform ambr250 and stir tank vessels. 
• Skill and knowledge of scaling up to 500 L or more in single-use technologies. 
• Knowledge of quantitative and qualitative analytical methods and interpretation of analytical data. 
• Ability to organize workload, oversee direct reports, and relevant resource requirements. 
• Skill in leadership duties, to include time management and planning. 
• Knowledge of products manufacturing following SOPs, batch records and working within a cGMP regulated environment. 
• Ability to observe technical issues with troubleshooting knowledge of process and equipment problems. 
• Ability to operate complex systems and equipment and optimize their use in manufacturing in accordance with defined goals. 
• Knowledge of specific product-related operations in protein purification. 
• Ability to mentor and train purification associates and leads in process transfer, scale-up, from scientific and engineering perspective.