Shift Time: 09:00 AM to 05:00 PM EST (Monday to Friday)
Rate - $85.00 - 87.00 per hour on w2
Job Description:
Department Descriptions:
Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.
Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement
Anticipate, respond to, and permanently resolve issues that arise during production.
Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.
Lead the creation and use of digital process data analytic systems.
Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.
Key Responsibilities
Provide technical leadership in the area of responsibility.
Provide technical/scientific support, expertise, and guidance to manufacturing and quality.
Ensure a solid understanding of engineering principles and theories in the area of responsibility and uses them to solve a range of complex problems in creative and practical ways.
Lead technical project team or cross-functional team between groups/organizations. Provide input and coordinates support from process development teams.
Review manufacturing processes and/or development and production data.
Design and conduct necessary experiments; contributes to understanding and interpretation of results; recommend changes or additional experiments.
Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.
Provide CMC support and guidance for product life cycle management.
Attend training and scientific meetings to remain current with technology and regulatory guidelines.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
Basic Qualifications:
Minimum of 3 years for MS Degree OR
Minimum of 7 years for BS Degree
Strong understanding of GMP environments, deviations, CAPA's
Experience with biologics downstream unit operations, Filtration, UF/DF, Chromatography, Viral clearance, and leachable and extractables.
Special Working Conditions:
Ability to gown and gain entry to manufacturing areas