Process Development CMC Leader

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.

The Process Development CMC Leader leads, manages and develops a cross-functional team of scientists, engineers and research associates focused on the development of cell culture and purification processes for biologics. The CMC leader drives all aspects of process development establishing scalable, robust processes which meet facility fit and product quality requirements for early and late phase client programs. Demonstrates ingenuity, creativity and resourcefulness managing a team of associates in all experimentation. Ensures responsiveness to clients and overall client satisfaction. Proposes, plans and implements long range technology programs that drive business value. Functions as an advisor to management in long range company planning.

Responsibilities

• Lead and mentor a team of scientists and engineers in the design, development and transfer of cell culture and purification processes for biologics. Lead optimization of processes to improve efficiency, facility fit, yield and product quality to meet client requirements.
• Drive the planning, execution and completion of the development activities ensuring adherence to the technical and timeline requirements. Monitor project progress and identify, evaluate and mitigate risks as necessary to meet program objectives.
• Manage the work activities of the group, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff and troubleshooting process and product-related issues.
• Provide expert technical guidance, mentorship and training to team members fostering a collaborative and innovative work environment. Accountable for knowledge of the team and application of good practices.
• Lead process characterization which includes generation of risk assessments, establishment of scale down models, evaluation and classification of process parameters and development of control strategies for commercialization.
• Review and approve documents including experimental plans, development reports, toxicology production reports, process optimization reports, scale down model protocols and reports, and process characterization protocols and reports.
• Drive improved collaboration throughout the organization including with cell line development, cell culture development, analytical method development, manufacturing sciences and technology and manufacturing for achievement of program objectives.
• Propose and champion innovative solutions that directly contribute to accelerating client programs or increasing business value.
• Advanced communicator of ideas, project goals and results across functions within the organization and to clients.
• Participate in and offer significant contributions to organizational strategic planning initiatives.
• Assist management in their responsibilities.
• Operate to the highest ethical and moral standards.
• Comply with Abzena's policies and procedures.
• Communicate effectively with clients, supervisors, colleagues and staff.
• Participate effectively as a team player in all aspects of Abzena's business.
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
• Perform other duties as assigned.

Qualifications

• MS degree in applicable scientific field, PhD degree preferred.
• Minimum either (8) years of directly related experience with a MS degree; with a PhD degree, minimum (5) years industrial experience in process development and cGMP manufacturing including a minimum of (2) years in a leadership role.
• Ability to work with a high level of scientific independence and direct others.
• Proven track record and extensive experience in developing and optimizing cell culture and/or purification processes for production of biologics.
• Demonstrated ability to be solutions driven.
• Demonstrated experience in managing multiple projects simultaneously.
• Ability to cultivate a collaborative work environment with a multidisciplinary team.
• Project and time management skills.