Downstream Manufacturing Associate Scientist
Company: Bayside Solutions
Posted on: May 10, 2022
Job Description Position Summary: The Downstream Manufacturing
Associate Scientist will actively contribute to the manufacturing
and technology transfer projects at the Fremont location. As part
of the Purification/Manufacturing group, you will have
opportunities to work on a wide-ranging set of projects for
troubleshooting and investigations, system and workflow
implementation, and tech transfers of processes into the GMP
manufacturing facility. The role will provide hands-on execution of
complex experiments in a team setting. The role will support GMP
readiness and manufacturing activities. The scope of
responsibilities may include but are not limited to Document
writing (SOPs, Equipment URSs, etc.), equipment validation
execution support and single-use assembly design. Essential Duties
- Execute complex unit operations in GMP manufacturing suites,
including but not limited to chromatography, TFF, depth filtration,
virus filtration, and buffer preparation, under the supervision of
- Maintain your own training within the parameters of
- Equipment troubleshooting, pilot scale material generation,
non-GMP tox material generation, and GMP downstream manufacturing
activities are all supported.
- Per project requirements, write/review/approve technical
documents such as tech transfer protocols and reports, production
batch records, training materials, manufacturing SOPs, and
regulatory filing documents.
- Documents operate in accordance with cGMP and cGDP.
- Follows cGMP established by site and adheres to established
- Keep cleanroom standards, practices, and housekeeping in
accordance with SOPs.
- Recognize any minor issues with the equipment and immediately
notify leads/managers of any issues or discrepancies.
- Assess the impact of product issues and nonconformities on
product safety and efficacy, as well as project milestones.
- Contributes to quality activities such as investigations and
walk-throughs, as well as support for authoring deviations, CAPA,
and change control.
- Other duties as assigned, as well as the ability to work in
shifts Working Conditions:
This position required to work in a
lab/office setting. The role requires walking, standing, stooping,
kneeling, and crouching. The employee must occasionally lift and or
move up to 20 pounds independently. Qualifications
BS in Life Sciences, or related
discipline with 1-2 years of relevant experience, or combination of
experience and relevant advanced degree, preferably in biopharma
manufacturing role.Working knowledge of cGMP compliance as it
pertains to procedures, processes, and manufacturingWorking
knowledge of industry-standard purification processes (affinity,
IEX, SEC, viral inactivation and filtration, depth filtration, TFF,
UFDF, etc) and equipment (GE AKTAs, disposables)Experience with
process monitoring software and equipment software (UNICORN, Pi
Historian)Creative thinker that can identify better and more
efficient methods to address issues and gapsDemonstrate ability to
work independently and on cross-functional teamsAbility to
prioritize assignments and to manage multiple projects
Keywords: Bayside Solutions, Fremont , Downstream Manufacturing Associate Scientist, Other , Fremont, California
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