Dynavax Technologies

Senior Manager Bioassays Lab (m/f) - (limited to 2 years - Parental Leave Replacement)

DE-NW-Düsseldorf
2 weeks ago
Req. #
HP-224
# of Openings
1
Category
Quality Control

PRIMARY PURPOSE OF POSITION

 

MAJOR DUTIES OF POSITION

  • Perform and supervise quality control laboratory activities including drug substance release testing, drug product release testing, stability studies
  • Review test raw data and ensure accuracy and compliance
  • Prepare and review protocols and reports related to the above mentioned activities
  • Manage analytical work subcontracted to contract laboratories, review reports and ensure timely completion
  • Provide technical guidance in resolving issues as well as making process- and method improvements
  • Prepare and review SOPs on test methods and other procedures relevant to QC
  • Prepare and review study protocols and study reports for stability studies and test method validation studies
  • Prepare and review Deviation, CAPA and Change Control documents
  • Lead investigations on Deviations and OOS results
  • Represent QC in various internal and external meetings

KNOWLEDGE AND SKILL REQUIREMENTS

 

 

  • BS in life science / biochemistry
  • Several years biologics quality control working experience
  • Broad knowledge and experience in quality control, including analytical chemistry and stability
  • Broad knowledge of cGMPs and regulatory requirements for testing and validation pertaining to biotechnology and pharmaceutical industries
  • Must have laboratory experience with a variety of analytical techniques including, but not limited to, Biologics potency assays and ELISA
  • Broad knowledge of statistical evaluation of analytical results
  • Excellent communication, interpersonal and training skills, both in German and English
  • Excellent technical writing skills and experience in writing SOPs, both in German and English
  • Proven ability to establish collaborative working relationships; team-oriented and must be able to work independently
  • Excellent ability to prioritize and manage multiple projects and tasks
  • Personal attributes include flexibility, integrity, action- and goal-oriented

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed