Manager of Manufacturing Job at Abzena Inc. in San Diego

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.

The Manufacturing Sr. Manager at Abzena will primarily be responsible for leading and overseeing day-to-day manufacturing operations. This role ensures the timely production of high-quality products while adhering to cGMP, FDA, and other regulatory requirements.

Leadership

• Oversee all manufacturing activities, ensuring that production schedules are met in compliance with quality, regulatory and safety standards. Manage and mentor a team of manufacturing supervisors and associates. Track performance to provide Supervisors with career growth and development opportunities.
• Ensure optimal resource allocation to meet project timelines and customer requirements.
• Assist with technical and compliance investigations, inspections, and audits.
• Manage the timely review of GMP records for completeness, accuracy, and compliance in conformance with regulatory requirements.
• Draft, revise, and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation, as needed.

Quality and Compliance

• Ensure that all operations are in strict compliance with cGMP, FDA, and other regulatory requirements. Lead investigations, corrective actions, and preventative actions associated with process deviations/non-conformances, adapting strategies as needed to maintain high standards of 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 and 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

• 4-year degree is required
• 10 + years' experience managing teams in the pharmaceutical or biotechnology manufacturing industry.
• Must have a clear understanding of cGMP compliance.
• Preferred experience in contract manufacturing (CMO) environment.
• Experience with technology transfer, scale-up and validation process.
• Must have experience interacting with regulatory agencies.
• Proficiency in manufacturing software (e.g., MES, ERP and QMS systems)

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.

$100,000 - $150,000 a year

Shift A schedule is Sunday to Wednesday with off-shift coverage as necessary.

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.