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Sr. Scientist, Downstream Process Development
3 months ago
Position: Senior Scientist, Downstream Process Development
Location: King of Prussia, PA
Company: SK Pharmteco
This role is responsible for supporting early and late phase process development for viral vector purification for internal and client programs. The primary responsibility is the design, execution, and analysis of study results with added focus on late-stage process characterization. Study results are summarized and presented to clients. The ideal candidate should have prior process development experience with common purification techniques such as clarification, chromatography, UF/DF and ultracentrifugation. Experience in viral vector (Ad, AAV, LV) purification is a plus but not a requirement since purification techniques from biologics are transferrable. Potential for direct management of a team
of scientists.
Responsibilities
- Design, execution, and analysis of early phase and late phase purification studies covering clarification, chromatography, UF/DF, and ultracentrifugation.
- Authoring of client-facing protocols, reports and presentations summarizing study results.
- Direct interfacing with clients
- Supports -scale up to the non-GMP pilot lab
- Process SME in support of GMP manufacturing
- Collaborates with external vendors to evaluate new technologies for viral vector purification.
- Design and execution of studies in support of late-stage process characterization
- Potential management of a team of scientists
- Independently lead downstream portion of client-facing programs
- Requirements:
- BS/MS/PhD with a life science or engineering background.
- Minimum 10 years of experience with biologics and/or cell & gene therapy downstream process development.
- Experience with common purification techniques such as chromatography, filtration (depth filtration, UF/DF) and ultracentrifugation.
- Experience with process scale-down and scale-up.
- Ability to design experiments, follow procedures with attention to detail, and successfully execute experiments at the bench
- Demonstrated ability to maintain detailed execution records and perform data analysis
- Strong communication skills (e.g., clear, and concise) and a team player
- Strong time and project management skills
- Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
- Experience with late-stage process characterization
Skills:
- Excellent verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Ability to prioritize tasks and to delegate them when appropriate.
- Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities.
- Proficient with Microsoft Office Suite or related software.
- Takes ownership of the assigned project, consulting with management and peers
- Able to understand and interpret data/information and its practical applications.
