Senior Manufacturing Associate-Downstream
Company: RPMGlobal
Location: Berkeley
Posted on: May 24, 2023
Job Description:
The Senior Manufacturing Associate will have the opportunity to
coordinate and collaborate with other cross-functional departments,
including Quality, Facilities, Procurement, etc. This position
requires independent execution of quality systems (includes
initiation of critical work orders, change requests, deviations,
corrective action preventative action (CAPA)). There will be times
when work schedules change to accommodate the processing schedule.
Contribution and participation will be required for additional
assignments and projects including report writing, data analysis,
experiment/validation execution, data compilation/summarization,
etc. The Senior Manufacturing Associate will assist with planning
and scheduling of the upstream/downstream operations. The Senior
Manufacturing Associate will have more engagement and
responsibility for continuous process improvement.
Roles and Responsibilities:
- Assist CMC team with technical transfer activities.
- Assist in the creation of the Bill of Materials for the
upstream/downstream process.
- Assist in development and creation of the upstream/downstream
process.
- Monitor fermentation and purification operations (including
trouble shooting and diagnosis of instruments, equipment, process,
etc.)
- Set-up, prepare, and operate manufacturing
equipment/labware/assemblies (includes filtration skid,
chromatography skid, fermenter, autoclave/sterilizer, bench top
meters (pH/conductivity/osmometer), etc.) in accordance with
current good manufacturing practices (cGMP).
- Record and document procedures with detail and accuracy. This
includes batch records, training records, logbooks, standard
operating procedures (SOPs) and validation protocols.
- Execute quality systems (including critical work orders, change
requests, engineering change, deviations, corrective action
preventative action (CAPA)).
- Create and revise standard operating procedures, batch records,
specifications, etc.
- Weigh and prepare culture media, buffers, and
solutions.
- Coordination and collaboration of activities with other
departments, and with vendors
- Sample solutions and perform analytical assays (including cell
counts, pH, conductivity, etc.)
- Perform technical training (including hands-on and class-based
training)
- Identify and implement equipment and process
improvements.
- Plant cleaning (including floors, benches, bioreactors,
equipment, etc.) waste disposal, lean manufacturing and good
manufacturing practices (GMP)/compliance.
Requirements:
- Knowledge of downstream equipment (columns, skids,
flow/UV/pH/conductivity/etc. sensors), filtration equipment,
solution preparation equipment (laminar air flow hood, agitator
mixers, bench top meters) are essential for this position.
- Knowledge of upstream equipment (laminar air flow hood, shake
flask scale-up, single use bioreactors and control software, and
analytical instruments for cell count, osmolality, and metabolites)
are essential for this position.
- Attention to detail and accuracy for record keeping and
documentation is mandatory in this position
- Teamwork and communication are key attributes needed for this
position, as this role will be part of a small team within
manufacturing. A collaborative attitude and a positive work ethic
are key traits for success.
Education Requirements:
- 2 years of college science in Cell Biology, Biochemistry,
Chemistry, Biology, with 2 to4 years of related experience
- Or 4 to8 years of experience and/or training, or equivalent
combination of education and experience.
The targeted salary range for this position is $60,000 - $89,100
per year. Agenus is making a good faith effort to be transparent
and accurate around our hiring ranges. The salary offered is
commensurate with Agenus's compensation philosophy and considers
factors including, but not limited to, education, training,
experience, external market conditions, critical needs of the role,
and internal equity.
Keywords: RPMGlobal, Berkeley , Senior Manufacturing Associate-Downstream, Other , Berkeley, California
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