CDMO Project Lead Scientific at YOH Services LLC in Emeryville, California

Job Description:

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 development.


• Technical and scientific knowledge of biopharmaceutical processes, at both process development and/or manufacturing scales of operation.


• 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 process robustness.


• Ensure accurate and complete documentation of any scientific experimental plan, data and report.


• Author procedures/protocols or technical reports that include data interpretation.


• 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 Calorimetry (DSC).
  
  
  • 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, ultrafiltration/diafiltration).
  
  
  • 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 scale bioreactors:
  
  
  
  • 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 in the application process.