Process Development CMC Leader - Bioconjugation

Abzena; Bristol Township (Bucks County); On-site; USD 120,000 - 160,000; Full time

Job summary

Abzena is seeking a Process Development CMC Leader in Bristol Township, Bucks County. This role involves leading a cross-functional team focused on chromatography and purification processes for complex bioconjugates. The CMC Leader will ensure client satisfaction while managing process optimization and compliance with regulatory standards.

The ideal candidate will have a MS or PhD degree with extensive experience in process development. Strong leadership and communication skills are essential to foster team collaboration and deliver innovative solutions.

Qualifications

• 8+ years of related experience with a MS degree; 5+ years with a PhD.
• Proven track record in process development and cGMP manufacturing.
• Strong ability to manage multiple projects.

Responsibilities

• Lead and mentor scientists and engineers in chromatography processes.
• Drive execution of development activities ensuring timeline adherence.
• Provide technical guidance and foster a collaborative work environment.

Skills

Scientific independence

Chromatography optimization

Project management

Excellent communication

Collaborative work environment

Education

MS degree in applicable scientific field

PhD degree preferred

Job description

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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.