Scientist III-Sr Scientist, Analytical Development

Job Description
As a member of the Analytical Development team, this role will support the early and late stage drug development programs at Dynavax including oligonucleotides, proteins, and oligonucleotide-protein conjugates. Duties will include but not be limited to development, transfer, validation and life cycle management of analytical methods for drug substance and drug product release, stability and characterization.

Depending on the level, the incumbent may work independently with cross-functional teams to define project needs, deliverables and milestones to meet regulatory requirements, and assure business goals are met.

*LI-CB

Responsibilities:
•Support and conduct development, optimization, validation and life cycle management activities for analytical methods.?The Senior Scientist level will lead these activities.

•Create and review technical documents including analytical method development reports, method validation protocols and reports, standard operating procedures in compliance with regulatory requirements.
•Support quality assurance activities/reviews in Quality systems (e.g. Change Control,) to ensure compliance to procedures, current GMPs, and regulatory requirements.
•Provide documentation for the development and implementation of test methods by generating study plans, protocols, standard operating procedures and reports.
•Collaborate with other internal and external partners, and actively support testing of new drug candidates at various stages of development including commercial products.
•Manage the activities of external research laboratories that have been contracted to conduct assay development or sample testing.
•Manage technical transfer of assays to QC and Process Development and contract laboratories in a cGMP or GLP environment.
•Perform bench work up to 50% of the time.
•Provide scientific guidance to technical staff when appropriate.
•Other duties as assigned.

Qualifications:

•?PhD in relevant field with minimum of 4 years (scientist III level) of industry experience in assay development. The senior scientist level requires 8+ years experience.

?Must have experience with a wide range of analytical techniques including but not limited too HPLC, CE, spectrophotometric assays, SDS-PAGE, ELISA and Light Scattering is a must.

?Must have experience in analytical method validation for late stage biologics.

?Experience with analysis of oligonucleotides is a plus.

?Must have an understanding of statistical data analysis.

?Excellent analytical, technical writing, communication and data management skills are required.

?Experience working in a GLP/GMP or other regulated environment is required.

?Must have the ability to work independently, and multi-task under aggressive timelines to support department and corporate objectives.

?Must be a self-starter who is flexible, as well as action and goal-oriented.

?The Senior Scientist is a technical leader applying critical thinking and proven problem-solving skills.

?Must enjoy working in a fast-paced, team-oriented, and collaborative environment.

Company

Dynavax Technologies, Inc

Job Code

State or Province

California

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