Engineering - Assistant​/Associate Scientist

Assistant/Associate Scientist/Engineer

The Assistant/Associate Scientist/Engineer to join our Vector and Gene Delivery MS&T group in GDPAD. The successful candidate will design and execute experiments related to supporting commercial vector manufacturing processes. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

Duties/Responsibilities:

• Oversee lab activities and schedule
• Design studies to support commercial manufacturing deviation investigations.
• Support 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

Qualifications:

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

Physical Demands:

Position requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs. Occasional bending, twisting and stooping to allow for gowning into classified environment required.

Work Environment:

Position will require time in the office and lab. Position is a team & project-based position that will require occasional shift work, weekends, and holidays.