Process Development CMC Leader - Bioconjugation

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 100,000 - 140,000; Full time

Job summary

Abzena Inc. in Bristol Township seeks a Process Development CMC Leader to lead and manage a team focused on chromatography and purification processes for complex bioconjugates. This role involves establishing scalable processes for client programs and ensuring overall client satisfaction.

The ideal candidate will have a minimum of 8 years in process development, with strong leadership, project management, and communication skills. A PhD is preferred, and the position is exempt from FLSA regulations.

Qualifications

• Minimum of 8 years of related experience with a MS degree; 5 years with a PhD.
• Proven track record in developing and optimizing chromatography processes.
• Excellent written and verbal communication skills.

Responsibilities

• Lead and mentor a team in chromatography and purification processes.
• Drive planning and execution of process development activities.
• Oversee project progress and ensure adherence to technical requirements.

Skills

Chromatography process development

Bioconjugates production

Leadership

Project management

Collaboration

Communication skills

Education

MS degree in applicable scientific field

PhD degree preferred

Job description

Process Development CMC Leader

The Process Development CMC Leader leads, manages and develops a cross‑functional team of scientists, engineers and research associates focused on the development of chromatography and purification processes for complex bioconjugates. 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 chromatography and purification processes for complex bioconjugates. 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, process chemistry 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 chromatography and/or purification processes for production of bioconjugates.
• 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.
• Excellent written and verbal communication skills with the ability to present complex data to diverse audiences.
• Ability to perform successfully under pressure while prioritizing and managing multiple projects or activities.
• Ability to offer relevant and realistic strategic plans and recommendations.
• Ability to thrive in a fast‑paced, innovative environment while remaining flexible proactive and resourceful.

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.