Scientist I, Downstream Process Development

The Scientist I leads all aspects of purification process development from process definition to process characterization for client programs. Manages a team of associates to design and execute a series of experiments to drive program objectives. May propose new processes and technologies which lead to the acceleration of projects or drive business value. Serves as a client interface subject matter expert in purification.

Functions as an advisor to management on technical matters.

• Applies extensive practical and theoretical scientific or engineering expertise to the development of scalable and robust purification processes.
• With minimal direction, manages, designs and conducts a series of specific scientific experiments which contribute to client program objectives. Leads troubleshooting of processes, instrumentation and equipment.
• Functions as a technical lead in technology transfer from process development to clinical cGMP manufacturing including definition of bill of materials, process definition and batch record review. Serves as a process development lead during downstream operations. Provides technical troubleshooting and may recommend process equipment improvements.
• Designs and performs a series of bench scale experiments related to purification development and scale up such as depth filtration, sterile membrane filtration, tangential flow filtration, viral filtration and chromatography.
• May propose new technologies which lead to the acceleration of programs. Proactively identifies purification challenges and drives solutions.
• Consistently demonstrates a high level of scientific leadership.
• Leads and mentors a team of associates to effectively execute a series of experiments designed to meet the goals and objectives of client programs. This includes production of materials under standards and practices required for toxicology studies.
• Collaborates with cell line development, cell culture development, analytical method development, and manufacturing sciences and technology for achievement of program objectives.
• Effective communicator of ideas, project goals and results across functions and to clients.
• Functions as an advisor to top management on technical matters.
• Authors and reviews technical documents including experimental plans, development reports, toxicology production reports, process optimization reports, scale down model protocols and reports, and process characterization protocols and reports.
• 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 in correlated processes.
• This role has direct reports. Will be responsible for guiding and mentoring junior staff including conducting performance evaluations and encouraging career development within the organization.
• Oversees production schedules, materials, equipment and resource requirements.
• Maintains records to comply with regulatory requirements.
• Operates and ensures appropriate maintenance of production equipment as it relates to downstream production activities.
• 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.

• 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 2 years’ experience with a PhD degree.
• Knowledge of purification concepts including biochemical properties, protein production,…