Engineer, Drug Substance Bioprocessing/Process Development & Optimization – REMOTE (JP15073)

About the position 3 Key Consulting is hiring an Engineer, Drug Substance Bioprocessing/Process Development & Optimization for a consulting engagement with our direct client, a leading global biopharmaceutical company. IDEAL QUALIFICATIONS: Drug Substance Bioprocessing background required. 2+ years Prior experience in process development/ /Process Engineering environment, clinical or commercial scale manufacturing, or tech transfer, with specific experience in the implementation, scale up, and support of biopharmaceutical manufacturing processes. Experience leading or supporting process optimization/ continuous improvement projects Some understanding of regulatory and cGMP requirements. Experience with project management. Has the ability to manage projects independently, break down high level projects into smaller incremental tasks, and elevate relevant issues to project lead and line management. Some experience with digital tools and/or data visualization software (e.g. Tableau, Spotfire, Smartsheet, Sharepoint, AI tools). Excellent written and verbal communication. Able to adapt to changing business needs and operational requirements. Experience with issue resolution and ability to influence across support organizations. Bachelor’s degree (Chemical Engineering, Bioengineering or Biotechnology, computer science, or other quantitative discipline) IDEAL BEHAVIORS: Enjoys tackling challenges, working in teams, and excels at organizing information from numerous sources to provide well-constructed deliverables. High attention to detail and quality in work. Ability to collaborate well cross-functionally between departments and work closely with team members to accomplish larger tasks. Passion for proactively identifying opportunities and solutions through creative data analysis. Intellectual curiosity with ability to learn new concepts/frameworks and technology rapidly as needs arise. Ability to problem solve, conceptualize solutions independently, escalate issues appropriately, and integrate feedback. Ability to ask clarifying questions and seek guidance when necessary. Ability to manage multiple projects simultaneously and deliver results in a timely fashion. Accountable, Self starter, and quick learner Why is the Position Open? Supplement additional workload on team. Top Must Have Skills: Drug Substance Bioprocessing/Pharmaceutical background. Preference for candidates with previous experience in tech transfer, process development, clinical or commercial scale manufacturing, Experience leading or supporting business process optimization/ continuous improvement projects Soft Skills – Communication, self starter/ independent, quick learner, project management

Responsibilities

• Optimization of business processes related to Drug Substance pharmaceutical manufacturing, such as technology transfer.
• Generate business process documentation such as Guidelines, job aids, templates, and Standard Operating Procedures (SOPs), with feedback from SMEs and management.
• Collaborate with partner organizations to develop and deploy digital business process solutions to facilitate knowledge management and business process execution.
• Support strategy development to identify tech transfer business process pain points and deploy solutions to improve processes.
• Collaborating with multiple stakeholders to understand project timelines, create a project plan, and execute the project deliverables in a timely fashion.
• Develop visualization dashboards to communicate OKRs, metrics, and process improvements.
• Deliver presentations to management and cross-functional partners.

Requirements

• Drug Substance Bioprocessing background required.
• 2+ years Prior experience in process development/ /Process Engineering environment, clinical or commercial scale manufacturing, or tech transfer, with specific experience in the implementation, scale up, and support of biopharmaceutical manufacturing processes.
• Experience leading or supporting process optimization/ continuous improvement projects
• Some understanding of regulatory and cGMP requirements.
• Experience with project management.
• Has the ability to manage projects independently, break down high level projects into smaller incremental tasks, and elevate relevant issues to project lead and line management.
• Some experience with digital tools and/or data visualization software (e.g. Tableau, Spotfire, Smartsheet, Sharepoint, AI tools).
• Excellent written and verbal communication.
• Able to adapt to changing business needs and operational requirements.
• Experience with issue resolution and ability to influence across support organizations.
• Bachelor’s degree (Chemical Engineering, Bioengineering or Biotechnology, computer science, or other quantitative discipline)
• Drug Substance Bioprocessing/Pharmaceutical background.
• Preference for candidates with previous experience in tech transfer, process development, clinical or commercial scale manufacturing,
• Experience leading or supporting business process optimization/ continuous improvement projects
• Soft Skills – Communication, self starter/ independent, quick learner, project management
• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

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