About the role
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.
As a member of the manufacturing team at Abzena, you will be responsible for executing daily task in strict compliance with manufacturing batch records, SOP’s, and Good Manufacturing Practices (GMP). You will take ownership of the production process, facility, and environment to ensure smooth operations. Additionally, you will collaborate cross-functionally with key departments, including QA, MS&T, Facilities, and others to support successful and compliant manufacturing activities and responsibilities.
Example Plan Shifts/Training Schedule:
- First 2 weeks: 8 hour shifts, M-F
- Next 1-2 months: 10 hour shifts, Mon-Thurs
- After 90 days: 12 hour shifts, Sun-Tues & Alternating Wednesdays
Responsibilities
* Operate under cGMP manufacturing conditions. * Ensure compliance to training on all activities prior to GMP execution. * Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. * Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes. * Ensures right-the-first-time performance of all process steps. * Perform production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills. * Escalate process related issues as they arise * Inventory manufacturing lab supplies and ensure items are properly stocked. * Participate in batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. * Maintain cleanroom standards for cleanliness and order * Conduct activities in support of production schedules as directed by senior staff. * Work effectively and efficiently in a team environment. * Support multiple projects simultaneously. * Crosstrain on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group. * Perform manufacturing and process development activities for projects and products in collaboration with others. * Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements. * Review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation. * Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. * Operate to the highest ethical and moral standards. * Adjust to a flexible work schedule including weekend work, as needed. * Perform additional duties as assigned.
Qualifications
* A minimum of 2 years of experience in a GMP pharmaceutical/biotech environment role with a technical degree or equivalent combined years of both. * Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. * Experience with aseptic handling, including BSC operations to maintain the integrity of sterile systems. * Knowledge of purification using column chromatography * Experience using single-use technologies, such as tube welding, tube sealing, and disposable systems * A proven ability to confidently compute basic arithmetic operations.
Physical Requirements
* Ability to sit or stand for extended periods of time. * Frequently lift and or move objects at least 50 pounds in weight. * Ability to gown aseptically * 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.
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.