Sr. MSAT Manager

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.

TheSenior Manager of Manufacturing Sciences and Technology (MSAT) is a technical leadership position that directly supports product supply, strategic objectives, and client programs. Under the leadership of the MSAT Senior Manager, the MSAT team is responsible for technical and process support of clinical cGMP Manufacturing using multiple production platforms. The scope of support includes ensuring smooth and efficient technical transfers into manufacturing, documentation and technical writing, advanced troubleshooting of complex problems, and continuous improvement. This position is also responsible for maintaining a safe work environment in compliance with CAL OSHA and other local, state, and federal regulatory agencies.

Responsibilities

• Oversees and supports Engineers in managing tech transfer from PD to large-scale manufacturing.
• Oversees MSAT staff supporting on-the-floor cGMP operations for induction and cGMP production.
• Oversees and provides guidance on the implementation of new manufacturing equipment and automation solutions for cGMP production in collaboration with Process Development.
• Establishes, characterizes, and maintains cGMP manufacturing processes.
• Collaborates with Quality ensuring delivery of products meeting regulatory standards.
• Provides ongoing technical and problem-solving support to Manufacturing Operations and Quality.
• Provides a science-based and risk-based approach for the resolution of deviations, investigations and process issues through analysis of in-process, historical and scale-down data.
• Develops and translates process knowledge and understanding into manufacturing controls strategy (product, process, materials, environment, etc.) to ensure successful scale up and transfer.
• Supports Manufacturing to resolve complex process/product issues.
• Collaborates with Process Development in the gathering and analysis of manufacturing campaign data trends for process optimization opportunities for future client work.

Ancillary Job Functions (Other Duties May be Assigned)

• Assess needs and optimize manufacturing capabilities for the site based on product pipeline.
• Maintains and apply current good manufacturing practices (cGMP) knowledge, and of state-of-the-art technology and best pharmaceutical manufacturing practices.
• Supports activities for commercial readiness at Abzena.
• Works autonomously and with minimal supervision.
• Operates with ethical and moral standards in compliance with Abzena's policies and procedures.
• Communicates effectively with clients, supervisors, colleagues, and staff.
• Participates effectively as a team player in all aspects of Abzena's business.
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.

Qualifications

• Bachelor's degree in a Life Science, Engineering, or related discipline.
• 7+ years of direct experience in Biologics Manufacturing, Process Development and/or MSAT.
• Proven track record in cGMP at scale manufacturing operations support, including problem solving and successful delivery of cross-functional technical projects.
• Strong scientific background and expertise in biologics products for cGMP clinical operations.
• People manager with ability to achieve results through teamwork and leadership of others, streamlined execution, and innovation.
• Well-developed leadership and communication skills.
• Demonstrated ability to develop constructive and effective relationships with direct reports, colleagues, and senior management.
• Demonstrated ability to effectively communicate project tech transfer targets to meet management, customers, and staff expectations.

Physical Requirements

• Ability to stand for 1-2 hours at a time andsit for 2 to 3 hours at a time.
• Frequently lift and/or move objects up to 30 pounds.
• Stand/walk during the 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.

$140,000 - $180,000 a year

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.