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Associate Director, Upstream Process Development (RELOCATION)

Company: CyberCoders
Location: Gainesville
Posted on: May 17, 2020

Job Description:

Associate Director, Upstream Process Development (RELOCATION)
If you are an Associate Director, Upstream Process Development with experience, please read on!--RELOCATION PACKAGE--
Top Reasons to Work with Us
1. Based in Gainesville, We are a clinical stage biotech company.2. Our company has been around for over a decade, so we offer a unique balance of stability and a small, tight-knit feel.3. You will have the chance to work on exciting projects and products with a talented team.
What You Will Be Doing
- Manage a team, including hiring, training, career and goal development and assessment- Lead comprehensive development activities for viral vector production platforms, including cell line development and characterization, bioreactor process definition and scale-up and initial harvest and processing activities.- Serve as the upstream process development subject matter expert for technology transfer and collaborations.- Identify, test and implement, as appropriate, new technologies for process improvement and increased robustness of vector production platforms.- Represent the company, report results at relevant meetings and submit manuscripts for publication.- Identify, review and triage potential technology-related business opportunities in coordination with Business Development functional area.- Maintain a broad knowledge of the competitive manufacturing landscape for viral vectors.- Identify new intellectual property opportunities, and work with the Executive Director, Process Development and Intellectual Property Attorney to secure the appropriate filings. - Approach process development comprehensively, working closely with the Downstream Process Development and Analytical Development groups to understand the impacts of upstream changes prior to their implementation.- Work closely with our QA and Regulatory functions to develop and comply with internal standards and regulatory authority expectations in all aspects of GMP-focused processes.- Adhere to the best practices of research, data management and archiving. Observance, compliance, and updating of our Safety and Quality manual.
What You Need for this Position
- MS or PhD in Chemical Engineering, Biochemical Engineering, Biomedical Engineering or equivalent discipline- Creative approach to solving complex viral vector production challenges with 8+ years and a master's degree, or 6+ years a PhD years' experience in biopharmaceutical drug discovery, managing the development of new biological therapeutics and/or pharmaceutical products. - Prior experience in viral process development preferred.- Strong knowledge of cell and virus biology. Experimental proficiency in AAV vector research and production.- Working knowledge of QbD, DOE and/or PAT.- Familiarity with the range of IT software programs typically utilized in a biotech environment.- Experience working within a regulated environment with a working knowledge of GMP regulations.
What's In It for You
- Competitive salary- Annual bonus- Flexible PTO package- Health insurance- Stock based compensation- 401K matching- Comprehensive Team Building- Wellness Program- Educational support- Parental leave

So, if you are an Associate Director, Upstream Process Development with experience, please apply today!
- Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Keywords: CyberCoders, Gainesville , Associate Director, Upstream Process Development (RELOCATION), Executive , Gainesville, Florida

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