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
POSITION SUMMARY:
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 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
Additional Job Requirements:
Lab w/o blood & animal
Position Handles Hazardous Materials.
The hourly rate for this position is between $45.00 - $50.00 per hour.
Compensation: Factors that may affect starting pay within this range may include [geography/market, skills, education, experience, and other qualifications of the successful candidate].
Benefits: Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.