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Senior Process Engineer (Technology Transfer)

Company: a Pharmaceutical company located in Berkeley, CA
Location: Berkeley
Posted on: January 7, 2022

Job Description:

Senior Process Engineer (Technology Transfer)

RESPONSIBILITIES
Leading Biologics Drug Substance technology transfers and complex global Biologics projects by developing project objectives, requirements, strategy and schedule aligned with the overall Product Strategy, budget and timeline.
Establishing, leading, maintaining, and motivating high-performance cross functional project teams while serving as the project advocate within the organization.
Cultivating collaborative professional relationships with peers and stakeholders, actively listening to transform insights into actions, drive results, and contribute to a continuous learning culture
Executing several projects concurrently with global team while balancing competing priorities.
Enabling stakeholders/leadership to make effective decisions and actively manage risk reduction with contingency plans.
Demonstrating biotech scientific and operations knowledge to define requirements and author/review technical documents.
Understanding biotech product development through commercialization lifecycle for phase specific project planning.
Traveling a few times per year with potential short-term assignments to convey knowledge or ensuring project deliverables are met for reasons not limited to workshops, meetings, and start-up/execution activities

QUALIFICATIONS
Minimum 8 years of professional experience with a Bachelor of Science in Engineering, Biotechnology, Chemistry, or Biology
OR a Master of Science in Engineering, Biotechnology, Chemistry, or Biology a minimum of 4 years of professional experience
OR Ph D. Engineering, Biotechnology, Chemistry, or Biology with a minimum of 2 years of professional experience or an equivalent combination of education and experience;
Demonstrate knowledge in aseptic processing and technical expertise in at least one the areas of fed-batch and perfusion mammalian cell culture with cell separation techniques, purification liquid chromatography and tangential flow filtration systems, or analytical methods for biotech products;
Experience with the technology transfer of Biotech products or project management leading cross-functional teams in a scientific environment;
Strong ability to plan, prioritize and manage complex and conflicting activities in a timely manner;
In-depth knowledge of cGMP compliance requirements for human therapeutic protein production from development through commercialization of biotech products;
Manufacturing Sciences or Process Development or Operations or Analytical Methods experience in the biotech industry for drug substance processes;
Familiar with methods for technology transfer comparability assessments and process performance qualification;
Strategic and analytical thinking skills to assimilate complex information to identify risks and prepare balanced decisions;
Leadership and interpersonal skills to collaborate, influence, and coach effectively in a highly matrixed organization with local and geographically dispersed teams;
Strong verbal/written communication and data presentation skills, including an ability to effectively communicate with both business and technical teams

Keywords: a Pharmaceutical company located in Berkeley, CA, Berkeley , Senior Process Engineer (Technology Transfer), IT / Software / Systems , Berkeley, California

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