Manufacturing Associate II
Company: Cellipont Bioservices
Location: Poway
Posted on: June 15, 2022
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Job Description:
Job Description Job Summary: The Manufacturing Associate is
responsible for assisting in the planning and timely execution of
manufacturing operations for a cGMP-compliant state-of-the-art cell
processing/clinical manufacturing facility with emphasis on primary
cell isolation and cell culture in an aseptic processing
environment. The Manufacturing Associate is responsible for
following the standard practices outlined for the operation of the
facility in accordance with the regulatory requirements for the
manufacture of materials for our clinical studies, clinical trials
and products. Duties/Responsibilities: Assists the operation of a
state-of-the-art GMP cell manufacturing plant in accordance with
FDA, ISO, Environmental Health & Safety, Human Resources, EMA
regulations and other Quality System regulations, as applicable.
Ensures production area, processes and procedures are maintained in
compliance with internal and external compliance and operating
standards. Conduct ancillary activities in support of processing
functions, e.g. lab and equipment cleaning and maintenance,
inventory management and stocking, preparing shipping/packaging
materials, etc. Maintains a strong culture of safety, quality,
accountability, cost efficiency, on time delivery and customer
service. Ensures facilities are maintained in a continuous state of
readiness. Identifies and mitigates risks for the operation and
timely brings to the attention of a supervisor. Ensures relevant
manufacturing data are captured appropriately and accurately for
supporting regulatory filings for clinical trials. Assists with
evaluation of raw materials, in-process materials and finished
product(s), as needed. Inform Supervisor of equipment needs and
supplies required to avoid interruption in processes. Performs
other duties as assigned. Required Skills/Abilities: Understanding
of GMP and GDP requirements. Strong organizational, interpersonal,
written and oral communication skills. Excellent time management
and organizational skills, demonstrated ability to manage and
prioritize multiple projects and meet deadlines. Experience in a
matrixed-reporting environment. Able to demonstrate willingness to
problem solve and/or diagnose process/product/equipment problems.
Knowledge and understanding of standard operating procedures and
accompanying documentation. Ability to work well on teams of
various sizes, teams that change often, and ability to work alone
when required. Excellent verbal and written communication skills.
Excellent organizational skills and attention to detail. Excellent
time management skills, with proven ability to meet deadlines.
Strong analytical and problem-solving skills. Proficient with
Microsoft Office Suite or related software. Education and
Experience: Bachelors Degree in biologic or pharmaceutical sciences
or bioengineering, with demonstrated technical experience required.
2 years experience in cell manufacturing/commercial biologic drug
manufacturing operations in a GMP environment. Physical
Requirements: Prolonged periods of standing in clean room and at
times, sitting at a desk and working on a computer. Must be able to
lift 25 pounds repeatedly, ability to lift up to 50 pounds
occasionally. Manual dexterity to evaluate, install, and modify
equipment.
Keywords: Cellipont Bioservices, Poway , Manufacturing Associate II, Other , Poway, California
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