Associate Scientist- Vector Manufacturing
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
TOP SKILLS
- The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
- Experience should include management of lab activities, technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, and process characterization.
- Prefer experience with leading experiments and designing DOEs
- Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment preferred
Duties/Responsibilities:
- Oversee lab activities and schedule
- Design studies to support commercial manufacturing deviation investigations.
- Support the the execution of process characterization studies.
- Collaborate with commercial vector team to identify opportunities for process improvements, make formal recommendations.
- Lead identification and implementation of new technologies and procedures from Development into Manufacturing
- Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites
- Support the hands-on training of commercial process unit operations to Vector MS&T
- Identify, design and manage small capital engineering projects
Specific Knowledge, Skills, Abilities, etc:
- The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
- Experience should include management of lab activities, technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, and process characterization.
- Prefer experience with leading experiments and designing DOEs
- Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment preferred
- Prior experience with SOPs, cGMPs and how they are applied within a regulatory environment required
- Prior experience participating in process characterization preferred
Education/Experience/ Licenses/Certifications:
- Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing
- Preference given to candidates with experience performing process characterization
- Knowledge of cellular immunology and/or vector manufacturing a plus
- Experience with cGMP, ICH guidelines, PPQ (process validation), control strategy development, and working within a Quality organization
- Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
- Experience working in a self-driven, performance/results oriented, fast paced matrix environment
- Experience writing experimental plans and protocols
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