Dynavax Technologies

Senior Scientist

Location
Berkeley, CA, US
Posted
Mar 14, 2019
Ref
19-029N
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
Overview

Design and execute analytical method development, validation and compatibility studies to support early to late phase development and commercial manufacturing of Dynavax's drug product portfolio. Effectively interface and collaborate with cross-functional teams both internally and at CMOs/CTLs to manage and/or execute the studies required. Oversee analytical method transfer efforts and/or new analytical method development at CMOs/CTLs, and support CMOs/CTLs with appropriate analytical studies. Manage and author appropriate reports and documents in support of regulatory filings, and author sections of regulatory filings (IND, NDA, BLA, etc.) as a subject matter expert.

Responsibilities

  • Design and execute analytical method development, validation, method comparability and other studies, evaluation of data, recommendations on strategy, and authoring reports to support phase appropriate development and commercial manufacturing of Dynavax's drug product portfolio.
  • Manage technical transfer efforts and/or validation of new or existing analytical methods at CMOs/CTLs. Support CMOs/CTLs with the appropriate studies during the development and validation phases of projects.
  • Provide applicable analytical expertise to enable timely completion of non-conformance and other investigations.
  • Manage and author appropriate development reports and other documents for internal use and support of regulatory filings. Maintain awareness and act as expert on the technical expertise areas and regulatory CMC requirements.
  • Supervise research associate and entry level scientist staff performing analytical method development, validation, compatibility, and other analytical studies.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • This position is a hands-on, laboratory based scientist position and may travel up to 10%.
  • Other duties as assigned


Qualifications

KNOWLEDGE AND SKILLS REQUIRED:
  • PhD in analytical chemistry, chemical engineering, biochemistry, pharmaceutics, or closely related discipline.
  • Five to eight years' relevant industry experience in a pharmaceutical CMC/GMP environment such as analytical development and/or Quality Control, etc.
  • Demonstrated expertise in analytical method development and validation supporting drug product development and commercial manufacturing.
  • Demonstrated knowledge of CMO/CTL management, manufacturing, and regulatory CMC.
  • Excellent written and verbal communication skills to effectively interface across functional teams and present technical concepts and results.
  • Must have the ability to identify and resolve critical issues, implement technical, strategic and operational plans.
  • Demonstrated team leadership experience.
  • Knowledgeable in current pharmaceutical/biological analytical technologies.
  • Demonstrated ability to synthesize information to make critical decisions in a timely manner.
  • Excellent interpersonal skills, with proven ability to build positive work relationships across functional lines and to motivate employees.
  • Ability to effectively manage multiple projects.
  • Proven problem-solving skills.
  • Personal attributes required include:
    • Integrity and flexibility,
    • Goal oriented and self-starter,
    • Practical approach to problem-solving,
    • Demonstrated good judgment and decision-making experience,
    • Collaborative and team oriented.


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