Manufacturing Science & Technology Specialist III

South San Francisco, California
Jul 13, 2018
Aug 12, 2018
Field of specialization
Work Function
Job Type
Full time

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

     * Proficient in performing all responsibilities of a MSAT Specialist II including bioprocess operations in all areas of GMP (Seed Train, Cell Culture, Purification, Conjugation, Formulation and Aseptic Filling) with minimal supervision
     * Keeps current and develops deeper and broader expertise in own functional area.
     * Demonstrates proficiency in the application of basic manufacturing, engineering and/or scientific theories, principles and techniques used in GMP Manufacturing processes
     * Keeps up to date on all training requirements; creates new training material, as needed
     * MSAT subject matter expert on at least one GMP area / equipment
     * Leads or participates in GMP document prep and review including SOPs, Batch Production Records (BPR), controlled memo and Qualification protocols
     * Ability to troubleshoot both equipment and process issues
     * Assist GMP support functions as needed including Inventory Management, Maintenance and Shipping
     * Leads or participates in new technology evaluation and implementation efforts
     * Trains new employees on GMP operations
     * Lead deviation and change control process

Additional Responsibilities

     * Collaborate with PS in technical review of new processes and coordinate execution of clinical production campaigns
     * Lead or participate in vendor meetings for new technology evaluations, equipment procurement, and vendor related quality investigations
     * Participate in equipment qualification activities including FAT and SAT
     * Identifies and leads efficiency improvement projects independently or in cross-functional teams

* BS/MS in Life Sciences with 4+ 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
     * High degree of self-motivation with ability to work under pressure and against tight timelines
     * Familiarity with lab techniques and procedures
     * Ability to work as part of a team and work independently with minimal supervision
     * 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