Sr Manufacturing Associate

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 Senior Associate is responsible for organizing and leading operations and training associates involved in all aspects of biologics production in a single use facility, including cell vial thaw and inoculum train expansion inside a Bio-Safety Cabinet (BSC), operation of wave and stirred-tank bioreactors up to 2000L, clarification and sterile filtration, and master cell bank fills including operation of chromatography skids in conjunction with multi-use and single-use columns, processing intermediates by depth filtration, ultrafiltration and diafiltration, and performing bulk drug substance fills. 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

• Ensures compliance with cGMP manufacturing requirements.
• Provides hands-on training for staff to ensure compliance prior to GMP execution.
• Adheres to gowning procedures required for working in ISO 7 and ISO 8cleanrooms.
• Performs operations in a bio-safety cabinet using good aseptic technique.
• Leads batch readiness activities, including planning, coordination, requests, transfers, and material and equipment staging.
• Sets up, operates, and maintains equipment including single-use bioreactors and centrifuges, large scale filtration skids, purification columns, automated filling machines, and instruments.
• Performs activities including thawing cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell banking.
• Performs purification operations including buffer preparation, column preparation (packing, pre-qualification, etc.), chromatography, UF/DF filtration, dead-end filtration, and DS filling.
• Monitors processes and results and troubleshooting issues to ensure process success.
• Provides detailed observations, analyzes data, and interprets results.

Qualifications

• Batchelor's degree including laboratory work in a chemistry, biology, or related field.
• At least 3 - 4 years of biological drug substance manufacturingexperience in a GMP pharmaceutical/biotech environment role.
• Demonstrated knowledge and understanding of cGMPs and how they apply to responsibilities.
• Skilled insingle-use technologies and aseptic processing, including BSC operations.
• Strong technical and mechanical aptitude in bioprocessing, including column chromatography.
• Experienced in leading, training, and coaching peers.
• Confident in math skills for arithmetic operations and computer proficiency.

Physical Requirements

• Ability to stand for 1-2 hours at a time and sit for 2 to 3 hours at a time.
• Frequently lift and/or move objects at least 30 pounds in weight.
• 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.

$70,000 - $100,000 a year

FLSA: Non-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.