AbbVie Manufacturing Science and Technology Specialist in South San Francisco, California

Manufacturing Science and Technology Specialist

USA, California, South San Francisco

Manufacturing & Operations

Requisition #1801887

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica®, Venclexta™, and Empliciti™ — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.

AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at Stemcentrx, AbbVie's South San Francisco, CA location.

Description

MSAT Specialist will be part of a small GMP Manufacturing team working in collaboration with Process Sciences and Quality to execute GMP production runs to supply the company’s clinical Antibody Drug Conjugate (ADC) pipeline. They will perform on-the-floor operations within the biologics production facility to produce clinical material for human trials using state of the art single-use disposable technology. They will support activities related to buffer prep, maintenance, supply planning, shipping/receiving, and quality testing with additional opportunities to lead technology projects, coordinate processes and participate in tech transfer.

Primary Responsibilities

  • Understand basic manufacturing, engineering and/or scientific theories, principles and techniques used in GMP Manufacturing processes

  • Keep up to date on training requirements

  • Perform GMP operations in Seed Train, Cell Culture, Purification, Conjugation and Formulation with some supervision

  • Media and buffer preparation

  • Equipment setup and maintenance

  • Automated skid recipe generation and data management

  • Train and qualify on Sterile Gowning and Aseptic Filling

  • Assist in GMP document prep and review including SOPs and Batch Production Records (BPR)

  • Participate in troubleshooting process and equipment issues

  • Assist GMP support functions as needed including Inventory Management, Maintenance and Shipping

  • Understand and participate in Quality management processes

  • Change management (DCRs, ECRs)

  • Event Reporting (ERs, DRs, CAPAs, QIRs)

  • May coordinate transfer of process from Development to GMP Manufacturing

  • May lead and/or participate in cross functional technology projects

  • May participate in vendor meetings for new technology evaluations, equipment procurement, and vendor related quality investigations

Additional Responsibilities

  • May coordinate transfer of process from Development to GMP Manufacturing

  • May lead and/or participate in cross functional technology projects

  • May participate in vendor meetings for new technology evaluations, equipment procurement, and vendor related quality investigations

Qualifications :

  • BS in Life Sciences with 0+ years relevant job experience

  • Acquires job skills and learns company policies and procedures to complete routine tasks

  • Experience in GMP operations and working with large-scale manufacturing equipment preferred

  • Works on assignments with some level of training and supervision

  • High degree of self-motivation with ability to work under pressure and against tight timelines

  • Must have excellent interpersonal and communication skills

  • Strong commitment to working safely, complies with all facility safety guidelines

  • Ability to work off-shift and long hours, as required

  • Mechanical aptitude, computer systems, and bioprocessing skills preferred

  • Ability to lift 30 lbs. is required

Equal Opportunity Employer Minorities/Women/Veterans/Disabled