Manufacturing Science & Technology Specialist II (Senior Bioprocess Technician)

South San Francisco, CA, US
Sep 24, 2018
Required Education
Bachelors Degree
Position 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 p erform 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