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Scientist - GMP Bioprocess Development (Downstream)

Company: Medasource
Location: Durham
Posted on: January 15, 2022

Job Description:

Title: Scientist I, GMP Bioprocess Development (Downstream)
Location: Duke Human Vaccine Institute (DHVI)
Job Type: Direct Hire

Role Summary

The Scientist I will support the downstream development, tech transfer, and GMP execution of derived and vetted processes to produce innovative vaccine products in support of Phase I clinical trials. This position will be involved in bioprocess development and GMP production, including lab scale downstream process development, scaleup and tech transfer of processes into the GMP environment along with GMP execution support with associated regulatory compliance. The role also involves serving as a downstream technical lead for several projects as required, fostering innovation within the group, and the design of enhanced empirical strategies to enhance development lifecycles across immunogen constructs.

Responsibilities
Work interpedently yet collaboratively to perform downstream lab scale process development activities to include (60%):
Preparation and operation of disparate modes of process chromatography
AEX, CEX, HIC, Mixed Mode, Affinity, SEC, etc.
Tangential flow filtration (UF/DF)
Clarification approaches (depth filtration, centrifugation, and flocculation)
Nanofiltration and depth filtration
Buffer formulation and preparation
Viral clearance study design and execution
Process scale-up
Risk impact assessments
Document development and GMP activities compliant with regulatory requirements (5%)
Support and execute cGMP production, including equipment and material readiness (technical transfer), to meet project needs (10%)
Support GMP investigations via root cause assessments and supporting empirical studies (2%)
Collaborate across teams (cross functional) to plan development activities, foster understanding and serve as a downstream technical project lead as required; diligent engagement with upstream, analytical, GMP-Operations and regulatory functions to cultivate process capabilities and quality target product profile deliverables (5%)
Compile data, summarize analyses and present experimental results to facilitate collaborative decision making in regards to product safety, quality, facility fit and process capacities (10%)
Draft and review technical development reports (3%)
Foster innovation to enhance downstream developmental lifecycles and GMP capabilities (3%)
Contribute to the design of downstream training plans, proficiency matrix and facilitate training to enable efficient onboarding of new staff and foster continuous education across the group (1%)
Contribute to the design and draft of templates and platform documentation to enhance process development lifecycles (1%)

Education and Experience
Bachelor's degree in a science, engineering, or related field
6 years relevant experience in the biopharmaceutical industry or equivalent
GMP experience is required
An advanced degree (Master's, PhD) is preferred

Required Skills

Knowledge and hands-on experience with AKTA process chromatography systems or equivalent
Experience with operating and authoring methods in Unicorn Software is preferred
Knowledge and hands on experience with tangential flow filtration systems
Knowledge and hands on experience of depth filtration and nanofiltration
Knowledge and hands on experience in viral clearance
Basic analytical knowledge and hands on experience with analytical techniques to support downstream activities (SDS-PAGE, UV-Vis spectroscopy and SEC).
Must have the ability to work independently yet collaboratively to design and develop downstream processes with guidance from other scientists and the line manager
Demonstrated ability to solve complex problems with guidance from other scientists and the line manager
Demonstrated sufficient scientific impendence with rigor and cross-functional collaboration
Demonstrated innovation prowess to derive continuous improvements for process development and GMP manufacturing
Demonstrated training and presentation experience to foster tangible and intangible skill development across the group and cultivate scientific understanding throughout the organization
Strong oral and written communication skills

Keywords: Medasource, Durham , Scientist - GMP Bioprocess Development (Downstream), Other , Durham, North Carolina

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