Biomanufacturing Technician - Central Services

ONSITE POSITION - SHIFT - SUN-WEDS 10PM - 8AM.
I. Department Overview:
The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in
accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include
solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification,
mRNA and molecular therapeutics production, and small-scale fill/finish. Further, manufacturing operations is
tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste
reduction to maximize capacity outputs.
II. Specific Duties, Activities, and Responsibilities:
This position is an entry-level position in the Manufacturing team and is the starting point to acquiring the skills
and training required for a cGMP biomanufacturing environment. The Technician is responsible for the manufacture
of biopharmaceutical products within a clean room environment. The position is expected to follow detailed
instructions and established procedures with frequent supervision.
The Technician...
" accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating Procedures
(SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and with a focus on right
first-time execution.
" documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, Forms, and
other quality documentation.
" recognizes deviations from the intended procedure and raises awareness through the Rapid Response
process.
" proactively identifies safety, quality, and efficiency improvements.
" actively participates in the client Way (Continuous Improvement Culture).
" may lead Just Do It (JDI) Continuous Improvement activities and implement CI projects.
" may coach more junior team members on basic execution activities and act as an onboarding buddy to
bring new team members up to speed on culture and basic workplace expectations.
" participates in daily shift huddles and may lead shift exchange activities.
" performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste,
and maintenance of 5S standards.
" completes all training activities required to maintain quality compliance within expected milestones.
Biomanufacturing Central Services
" performs basic buffer preparation activities, including weighing raw materials for production.
Education/Experience:
Central Services
" High School Diploma.
ehavioral Requirements:
" Ability to see and hear and read and write clear English.
" Ability to communicate effectively and follow/retain detailed written and verbal instruction in an
accurate, timely, safe, and professional manner with supervisor, group members, and other departments as
necessary.
" Ability to manage time effectively to complete assignments in expected time frame and independently
seek out additional work when tasks are completed ahead of time.
" Ability to cooperate with coworkers within an organized team environment or work alone.
" Detail oriented and well organized with ability to work effectively under high pressure with multiple
deadlines.
" Ability to put aside personal opinions and focus on business needs, department needs or group needs.