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.
Abzena is seeking an experienced and highly motivated Manufacturing Manager to lead biologics manufacturing operations at its San Diego cGMP facility for expansion into Train 2-Shift A. The Manufacturing Manager will be responsible for the safe, compliant, and efficient execution of biologics production activities supporting clinical and commercial manufacturing programs. This role will provide leadership to manufacturing teams while ensuring adherence to cGMP regulations, quality standards, production schedules, and business objectives.The successful candidate will drive operational excellence, team development, continuous improvement initiatives, and cross-functional collaboration to support Abzena's mission of accelerating the development and delivery of life-changing biologic therapies. Abzena's San Diego site supports process development, analytical services, and cGMP manufacturing of biologics, including monoclonal antibodies, recombinant proteins, bispecifics, ADCs, and other complex biologic modalities.
Example Plan Shifts/Training Schedule:
- First 2 weeks: 8 hour shifts, M-F
- Next 1-2 months: 10 hour shifts, Mon-Thurs
- After 90 days: 12 hour shifts, Sun-Tues & Alternating Wednesdays
_Schedule is subject to change based on needs._
Responsibilities
Manufacturing Operations Leadership
- Manage day-to-day manufacturing activities for upstream, downstream, and process support operations.
- Ensure production campaigns are executed safely, efficiently, and in accordance with approved batch records and cGMP requirements.
- Coordinate manufacturing schedules to meet client and business commitments.
- Monitor production performance metrics and implement corrective actions as needed.
- Lead manufacturing readiness activities for technology transfers, process validation, and commercial production.
Quality and Compliance
- Identify, assess, and mitigate risks to ensure the safety, purity, quality, and effectiveness of manufactured products, developing contingencies to address potential challenges.
- Develop a successful team, building technical and leadership capabilities to meet current and future business needs.
- Ensure controlled documents for the area of responsibility are maintained, with active owners assigned for periodic reviews.
- Alert senior management of significant quality, compliance, supply, and safety risks.
- Accountable for the functional key performance indicators and evaluations for Management Reviews.
- Plan and oversee GMP activities for assigned areas through downstream levels of management.
- Support and drive Continuous Improvement initiatives, programs, and projects.
- Serve as the subject matter expert for the functional area during health authority inspections.
- Ensure the right people and resources are in place and optimally allocated to achieve results.
Project Management
- Collaborate with the MSAT team to transfer processes and technologies into manufacturing, ensuring a smooth transition by identifying potential risk and developing mitigation strategies. Lead and manage manufacturing projects from inception through completion, ensuring alignment with business objectives, timelines and quality standards.
- Ensure effective decision-making and clear, timely communication across the organization.
Safety & Training
- Promote and maintain a culture of safety, ensuring adherence to all safety protocols.
- Ensure ongoing training and development of manufacturing staff on new technologies, SOPs and regulatory guidelines.
- Demonstrate personal credibility and build strong working relationships across organizational and geographical boundaries.
- Ensure an adequate number of personnel with appropriate education, experience, and training in accordance with cGMP requirements
- Foster an environment that encourages accountability, innovation, continuous improvement, learning, and knowledge-sharing.
Qualifications
- Bachelor's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Biology, Life Sciences, or related discipline.
- 8+ years of experience in biopharmaceutical or biologics manufacturing within a regulated cGMP environment.
- 3+ years of direct people leadership experience.
- Strong understanding of biologics manufacturing processes, including upstream and downstream operations.
- Experience supporting clinical and/or commercial biologics manufacturing.
- Thorough knowledge of cGMP regulations, quality systems, and regulatory expectations.
- Demonstrated success leading teams in a fast-paced manufacturing environment.
- Strong problem-solving, organizational, communication, and leadership skills
- Travel between Abzena sites (local San Diego CA facilities) as needed.
Physical Requirements
- Ability to sit or stand for extended periods of time.
- Frequently lift and or move objects at least 50 pounds in weight.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to climb, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
