Scientist III- Upstream

Immediate need for a talented Scientist III- Upstream. This is a 12+months contract opportunity with long-term potential and is located in Framingham, MA(Onsite). Please review the job description below and contact me ASAP if you are interested.
 
Job ID: 25-59365
 
Pay Range: $80 - $85/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key Responsibilities: 

• 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.
• Provide technical support and routine process monitoring for upstream mammalian manufacturing of commercial products.
• Review manufacturing processes, deviations, and/or development and production data.
• Review manufacturing batch records, protocols, and control strategies.
• Provide technical support and data analysis for investigations and deviation resolution.
• Recommend changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
• Interact with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments.
• Oversee and report on overall manufacturing progress.
• Lead technical project team or cross-functional team between groups/organizations. Provide input and coordinate support from process development teams.
• 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.
• Provide technical guidance and train less experienced staff.
• Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

 
Key Requirements and Technology Experience: 

• Key skills; Upstream, CAPA, cell culture, Manufacture processing
• Bachelor’s degree in engineering or science with 5 - 7 years of experience
• Master’s degree in engineering or science with 3 - 5 years of experience
• PhD in engineering or science with 0 – 3 years of experience.
• Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues.
• Experience with biologics mammalian upstream unit operations: vial thaw, seed train, wave reactors, production reactors, harvest and capture column operations. Experience with perfusion cultures is highly preferred.
• Hands-on cell culture experience at laboratory or pilot scale.
• Understanding of cGMP concept and familiar with quality and regulatory framework.
• Proficiency in process data analytics.
• Knowledge of computerized systems in biopharmaceutical manufacturing environment, i.e., Distributed Control System, DeltaV Process Data Historian, LIMS, and MES.
• Experience leading projects and/or cross functional teams.
• Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
• Strong communication and technical writing skills. Experience communicating with business partners and senior management.
• Experience with root cause analysis and/or risk assessment
• Experience working with statistical analysis software
• Experience communicating with cross-functional teams and senior management
• Proficient in Microsoft Word, Excel, PowerPoint.
• Ability to gown and gain entry to manufacturing areas

 

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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