Manufacturing Manager

Salary Range: 125000 to 150000 (Currency: USD) (Pay period: per-year-salary)

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.