REMOTE: Sr. Scientist / Process Development Consultant (232036)

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Job Description:

This position will provide key technical expertise to support the process development and process characterization studies for viral specific T-cell pipeline which includes both early and late-stage therapies. This individual will engage both internal and external partners to define process requirements, develop and characterization of the processes. This position requires a hands-on individual with an understanding of Quality by Design (QbD) and process modeling, and a track record of achievement in the development and characterization of manufacturing processes for cell and/or gene therapy programs.

Responsibilities:

 Drive the design, execution, and analysis of process development studies to develop a thorough understanding of operational parameters and performance attributes, along with the impact to critical quality attributes (CQAs).

 Perform multivariate DOE studies for identification of critical process parameters and parameter range finding. Compile, organize, and analyze data across multiple experiments to enable process understanding and logical, data-driven decisions.

 Author technical documents (SOPSs, protocols, reports, risk assessments, specifications, CQAs), including drafting, reviewing, approval.

 Support CMC regulatory submissions (IND, BLA, etc) via authorship, review, approval of relevant CTD sections.

 Support technology transfer to external manufacturing partners and provide support in process scale-up.

 Provide laboratory support for manufacturing deviation investigations and evaluation of raw material and consumables changes.

 

Skills:

 Demonstrate expertise in cell culture development of gene and / or cell therapies.

 Experience with closed system processing methods for cell therapies, blood and cell processing technologies, and cell characterization methods is highly desired.

 Possess skills in experimental design (e.g. DOE) and data analysis; experience with applying quality risk management tools to parameter selection and criticality classification.

 Experience with applying Quality by Design (QbD) principles to process characterization and the product development lifecycle.

 Experience authoring scientific publications and CMC regulatory submissions.

 Ability to translate complex scientific concepts into study design and data into reports and presentations is required.

 

Education:

Required, bachelor’s degree or Master’s degree in Life Sciences or Engineering and 5+ years of relevant work experience. PhD preferred with 2+ years of relevant work experience.

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote, United States

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