Overview
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
Role Summary
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.
Responsibilities
- 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.
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 2 years’ experience with a PhD degree.
- Knowledge of purification concepts including biochemical properties, protein production, characterization, and scaling of purification processes.
- Knowledge and skills in relation to purification process steps including depth filtration harvest, chromatography, tangential flow filtration, and viral clearance considerations.
- Understanding of purification process design limits for implementation in a clinical manufacturing environment.
- Knowledge of design of experiments using statistical software for increased purity in relation to operation of multivariate experiments.
- Knowledge of quantitative and qualitative analytical methods and interpretation of analytical data.
- Ability to organize workload, oversee direct reports, and relevant resource requirements.
- Skills in leadership, including time management and planning.
- Knowledge cGMP requirements.
- 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.
- Ability to mentor and train purification associates in process transfer, scale-up, from scientific and engineering perspective.
