Abzena plc

Process Development CMC Leader - Bioconjugation

Abzena plc • $120K — $150K *
Bristol, PA 19007In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • MS degree in applicable scientific field, PhD preferred.
  • 8+ years of experience with MS degree; 5+ years with PhD in process development and cGMP manufacturing.
  • Demonstrated experience in chromatography and/or purification processes for bioconjugates.
  • Proven ability to manage multiple projects simultaneously.
  • Strong project and time management skills.
  • Excellent communication skills for diverse audiences.

Responsibilities

  • Lead and mentor a team in chromatography and purification process development.
  • Drive project execution ensuring technical and timeline adherence.
  • Manage team activities, resources, and client communications.
  • Provide technical guidance and training, fostering collaboration and innovation.
  • Conduct process characterization and develop control strategies.
  • Review and approve technical documents related to process development.
  • Enhance collaboration across relevant scientific departments.
  • Propose innovative solutions to accelerate client programs.

Benefits

  • Opportunity to work in a fast-paced, innovative environment.
  • Exposure to a variety of cross-functional projects.
  • Mentorship and professional development within a collaborative team.
  • Participation in strategic planning initiatives.
  • Ethical workplace culture aligned with high standards.
Full 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

About Abzena plc

Abzena is a life sciences group with headquarters in Cambridge, UK and offices in the US and Japan. The company provides technologies and complementary services to enable the development and manufacture of biopharmaceutical products. Abzena's services and technologies are used by a range of companies and academic organisations across the pharmaceutical industry, including small biotech to large pharmaceutical companies. The company's proprietary technologies include composite human antibodies and site-specific conjugation technologies, which enable the development of antibody drug conjugates (ADCs) and other biotherapeutics. Abzena's services include antibody discovery and engineering, immunology services, bioassays, cell line development, and biomanufacturing. The company has a range of partnerships and collaborations with pharmaceutical companies and academic institutions, and has a number of products in clinical development.
Learn more about Abzena plc
Size
200 employees
Industry
Pharmaceuticals & Biotech
Founded
2014
Revenue
$17 million
NASDAQ
ABZA
* Ladders Estimates

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