MSAT Scientist (Max $75/hr W2)

Company Description

Pharma

Job Description

*Schedule - M-F 40 hours/week. Onsite at least 3 days per week (must be flexible to be onsite M-F if the schedule were to change in the future).

Looking for Senior level resources with hands-on experience (not just managing but doing the work)
HOWEVER, they also must be flexible to provide on-call support (after hours/weekends/holidays) the team rotates the on-call responsibility every few weeks.
Manufacturing Science and Technology (MSAT) Scientist III. As a member of the MSAT Team, responsible for the successful transfer of viral vector bioprocesses into GMP production. As such, you are in direct contact with our clients and internal cross functional teams. Scientist III will ensure successful process scalability and manufacturability. Scientists in this role are responsible for all the process integration-related aspects of work during campaign preparation, process supervision, reporting during and after production campaigns, leading relevant major deviations and continuing manufacturing process improvement under the supervision of a Sr. Scientist and/or Manager.

Requirements:
Bachelors degree in Science related field
MS or Ph.D. is preferred
5-10 years of experience
• GMP manufacturing support (Viral Vector or Cell and Gene Therapy preferred; microbial or mammalian processing support required if VV/ CGT background is limited or non-existent), and basic understanding of current Good Manufacturing Practices, US / EU regulations.
• Advanced knowledge of cellular biology, cell culture, scale up, mass transfer, bioreactor operation, and / or depth filtration, tangential flow filtration, chromatography, viral filtration; buffer and media production; aseptic processing
• Demonstrates critical thinking skills in problem solving and decision making
• Ability to explain technical problems in terms sufficient for other technically-trained people to understand the problem and proposed solutions, both verbally and in writing
• Ability to independently lead small projects and to create, maintain, and utilize the cross-functional support of other departments within the asset for the accomplishment of objectives
• Ability to perform basic and advanced root cause analysis techniques for resolving deviations and identifying appropriate CAPA: Five why, Kepner-Tregoe, Fishbone, Pareto, Scatter plotting, DMAIC for RCA
• Ability to perform basic risk identification and remediation and lead basic and advanced risk assessments using standardized methodologies which could include FMA, FMEA, HAZOP, and/ or HACCP
• Attention to detail and high level of accuracy
• Some knowledge of statistical data analysis is a plus
• Strong communication, technical writing, organizational and interpersonal skills; able to give accurate and complete guidance and direction to junior scientists for smaller issues and problems

Additional Information

All your information will be kept confidential according to EEO guidelines.