Scientist III/Sr. Scientist Process Development - Berkeley, CA | Biospace
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Scientist III/Sr. Scientist Process Development

Dynavax Technologies

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Location:
Berkeley, CA
Posted Date:
6/28/2017
Position Type:
Full time
Job Code:
17-001R
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Formulation, Manufacturing, Manufacturing/Production, Process, Process Development,

Job Description

Design and execute formulation and compatibility studies; evaluate the critical components and process parameters to support early to late phase development of Dynavax’s drug product portfolio. Effectively interface and collaborate with cross-functional teams both internally and at contract manufacturing/clinical research organizations (CMOs/CROs) to manage and/or execute the studies required.  Oversee technical transfer efforts and/or manufacturing of new or existing drug product at CMOs and support CMOs with appropriate studies during the development and validation phases of projects.  Manage and author appropriate development reports and documents in support of regulatory filings, and author sections of regulatory filings (IND, NDA, BLA) as a subject matter expert.

Requirements

Design and execute formulation, compatibility, and process studies to support phase appropriate development of Dynavax’s drug product portfolio. Duties will include, but not limited to design of programs, evaluation of data, recommendations on strategy, and authoring reports.
Manage technical transfer efforts and/or manufacturing of new or existing products at CMOs. Support CMOs with the appropriate studies during the development and validation phases of projects.
Manage and author appropriate development reports and other documents for internal use and support of regulatory filings. Maintain awareness and act as expert on regulatory CMC requirement.
If appropriate, supervise research-associate-level staff performing formulation, compatibility, and analytical studies.
Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
The senior scientist level may spend up to 25% in the laboratory.
This position may travel up to 15%.
Other duties as assigned.

Education:

PhD in chemistry, chemical engineering, biochemistry, pharmaceutics, or closely related discipline.
The Scientist III will have 5 to 8 years’ relevant industry experience and the Senior Scientist 10+ years’ relevant industry experience in a pharmaceutical CMC/GMP environment such as process development, formulation, etc.
Demonstrated expertise in drug product development
Demonstrated knowledge of formulation, process development, manufacturing, and regulatory CMC.
Must have experience with CMO management and oversight, especially for the senior scientist level.
Exceptional 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.
Knowledgeable in current pharmaceutical/biological analytical technologies.
Demonstrated ability to synthesize information to make critical decisions in a timely manner.
Exceptional 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:
Flexibility and integrity,
Goal oriented and self-starter,
Practical approach to problem solving,
Demonstrated good judgment and decision-making experience,
Collaborative and team oriented.
ADDITIONAL KNOWLEDGE AND SKILLS DESIRED:

Experience with aseptic processing and vaccine formulation a plus.
Demonstrated team leadership experience.
Experience with early phase formulation and process development.