CDMO Project Lead
Company: Yoh, A Day & Zimmermann Company
Location: San Leandro
Posted on: February 19, 2021
Yoh Life Sciences is seeking a Project Lead for a CDMO client in
the San Francisco East Bay. See below for complete job
responsibilities and requirements. If after reviewing, you are
interested in learning more about this, or other opportunities
please apply with your updated resume ASAP.
Title: CDMO Project Lead
Primary Duties: Review technical documentation from client and
prepare risk assessments and project plans, including defining and
scheduling the activities required to execute project scope.
Lead a technical team and manage a recombinant protein development
project in a GLP/GMP environment.
Responsibilities include but are not limited to:
Experience with technical transfer at various project stages
including gap assessment, facility fit and timeline
Technical and scientific knowledge of biopharmaceutical processes,
at both process development and/or manufacturing scales of
Knowledge of process scale-up and scale-down methodologies,
including process characterization and design of experiments.
Basic statistical data analysis
Prepare and present technical data.
Use MS Office software (MS Excel, MS Word, MS PowerPoint) and
application software (not limited to) including Unicorn, JMP,
Minitab, Design Expert, etc.).
Execute complex scientific protocols in a highly coordinated team
environment from preparation, testing, and data analysis.
Work closely with MS&T Team members, be engaged in the planning
of experiments resulting from campaign learnings to increase
Ensure accurate and complete documentation of any scientific
experimental plan, data and report.
Author procedures/protocols or technical reports that include data
Ensure own experimental and testing work is performed exactly as
defined in the approved study protocols or SOPs/guidelines.
Maintain work space and equipment in accordance with company
policies and industrial best practices.
Maintain work space in a clean and organized manner to ensure
efficient performance of activities.
Troubleshoot, repair, clean and operate equipment as needed.
Education and Experience Requirements:
Biology, Chemistry, Toxicology, PhD +3 years or MS +6 years exp. or
BS +8 years exp.
Experience with contract manufacturing is desired.
Key Skills, Abilities, and Competencies:
Understanding of analytical testing methods including:
SDS-PAGE, HPLC, Amino Acid Analysis, ELISA's and in vitro
diagnostic test kits, Lowry, Bradford, Western Blotting, Mass
Spectrometry, Dynamic Light Scattering, and Differential Scanning
Development and qualification of methods.
Understanding of protein purification of recombinant proteins and
monoclonal antibodies including:
Chromatography, affinity, ion-exchange, hydrophobic, mixed mode,
experience working with AKTA, Unicorn, clarification/filtration,
Process development and optimization including process parameter
optimization, process characterization.
Execute protocols ranging from resin screening, chromatography,
filter sizing and TFF optimization.
Use AKTA Avant and Pilot systems and associated software, AKTA
Unicorn and Assist software.
Understanding of set up, operation and sample bench-scale/pilot
10L / 200L stainless steel microbial fermenters.
5L / 2L Sartorius glass benchtop fermenters.
Cell culture wave bags.
AMBR high throughput screening (cell culture).
Complexity and Problem Solving:
Understanding of microbial fermentation/cell culture using
different hosts per defined protocols.
Understanding of different harvesting and cell lysis techniques
such as centrifugation/continuous centrifugation (disc stack
centrifuge), filtration, dynomill, microfluidzer.
Other Job Requirements:
Ability to work periodically out of normal business hours.
Adhere to all site safety, environmental and industrial hygiene
procedures and practices, and actively participate in maintaining
and enhancing the safety of the workplace and the laboratories.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or status as a
protected veteran. Visit
https://www.yoh.com/applicants-with-disabilities to contact us if
you are an individual with a disability and require accommodation
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Keywords: Yoh, A Day & Zimmermann Company, San Leandro , CDMO Project Lead, Other , San Leandro, California
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