Sr Manufacturing Associate - Shift B at Abzena in Carlsbad, CA

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 Senior Manufacturing Operator is responsible for executing complex GMP manufacturing operations supporting biologics production in a single-use manufacturing facility. This role performs advanced upstream and downstream processing activities, serves as a technical resource, supports training activities, assists with troubleshooting, and contributes to continuous improvement while maintaining compliance with cGMP requirements.

The Senior Manufacturing Operator will primarily be responsible for 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.

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, Thurs-Sat & Alternating Wednesdays

Schedule is subject to change based on needs.

Responsibilities

Manufacturing Operations Individual Skills - Execute upstream and downstream GMP manufacturing activities according to approved batch records and SOPs. - Perform cell thaw, inoculum expansion, bioreactor, harvest, purification, filtration, and bulk drug substance operations. - Set up, operate, monitor, and maintain manufacturing equipment and single-use processing systems. - Perform aseptic operations in cleanroom environments. - Support validation, engineering, and GMP manufacturing campaigns. - Support media and buffer preparation, inoculum expansion, bioreactor operations, harvest, chromatography, UF/DF, sterile filtration, and bulk drug substance filling. - Ensure activities are performed according to approved batch records, SOPs, and production schedules. - Provide hands-on training and qualification support for manufacturing personnel. - Review GMP documentation for completeness, accuracy, and compliance. - Support deviations, CAPAs, change controls, and quality events. - Troubleshoot process, equipment, and operational issues. - Partner with QA, QC, MSAT, Engineering, Facilities, Supply Chain, and Program Management. - Train Manufacturing Associates.

    **GMP Compliance & Quality**
- Ensure strict compliance with cGMP regulations, company procedures, and regulatory requirements.
- Review and verify batch documentation for accuracy and completeness.
- Support investigations, deviations, CAPAs, change controls, and quality events.
- Participate in internal audits, client audits, and regulatory inspections.
- Ensure proper documentation practices and data integrity standards are maintained.

    **Process Execution & Technical Support**
- Serve as a technical resource for manufacturing equipment and processes.
- Assist with training and qualification of Manufacturing Operators.
- Provide guidance on GMP documentation and aseptic technique.
- Support onboarding and development activities.

    **Safety & Operational Excellence**
- Champion Environmental Health and Safety (EHS) compliance.
- Ensure safe handling of biological materials, chemicals, and manufacturing equipment.
- Lead risk assessments and support implementation of corrective actions.
- Drive Lean Manufacturing and continuous improvement initiatives.
- Monitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence.

Qualifications

• BA/BS degree that included laboratory work in a chemistry, biology, or related field.
  • At least 2 – years of purification experience in a GMP pharmaceutical/biotech environment role.
  • Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities.
  • Skilled in aseptic handling, including BSC operations to maintain the integrity of sterile systems.
  • Skilled with using single-use technologies
  • Strong technical and mechanical aptitude in bioprocessing.
  • Knowledge of purification using column chromatography
  • Experience leading, training, and coaching peers.
  • Computer proficiency
  • A proven ability to confidently compute basic arithmetic operations.

Travel between Abzena sites (local San Diego CA facilities ) as needed. ****

Physical Requirements

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.

• Frequently lift and or move objects at least 30 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.

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.