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Lead GMP manufacturing operations for biologics production, overseeing both upstream and downstream activities. Supervise and develop manufacturing personnel while ensuring strict adherence to cGMP regulations and production schedules.
Requires a Bachelor's degree in a scientific discipline and 5-8 years of biopharmaceutical manufacturing experience in a GMP environment. Must have at least 2 years of leadership experience and hands-on expertise in biologics operations.
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 Supervisor is responsible for leading GMP manufacturing operations supporting biologics production, including cell culture, fermentation, harvest, purification, and bulk drug substance manufacturing activities. This role provides direct supervision of manufacturing personnel, ensures compliance with current Good Manufacturing Practices (cGMP), and drives safe, efficient, and high-quality execution of manufacturing campaigns.
The supervisor serves as a key operational leader, coordinating production activities, managing shift resources, supporting technology transfer and process validation activities, and partnering with Quality, Process Sciences, Supply Chain, Facilities, and MSAT teams to achieve production objectives. This role will be dedicated to the manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream.
Schedule is subject to change based on needs.
\nResponsibilities
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.
Abzena is the leading end-to-end bioconjugate & complex biologics CDMO+CRO, focused on rapidly moving medicines forward.
Abzena is the leading end-to-end bioconjugate, ADC, and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule and move medicines forward faster. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK.
Offices: 6325 Lusk Blvd, San Diego, California 92121, US · Babraham Research Campus, Babraham, Cambridge, Cambridgeshire CB22 3AT, GB · 360 George Patterson Blvd, Suite 101E, Bristol, PA 19007, US · 11425 Sorrento Valley Rd, San Diego, California 92121, US · 2858 Loker Ave E, Carlsbad, California 92010, US
