Engineer, Drug Substance Bioprocessing/Process Development & Optimization - REMOTE (14)

Engineer, Drug Substance Bioprocessing/Process Development & Optimization

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.

Job Description:

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

Day to Day 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.

Basic Qualifications:

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

Red Flags:

• No Drug substance tech transfer/engineering experience
• No experience with continuous improvement
• No experience with cross functional teams
• No independent leadership. Roles are purely task based

Interview process:

Phone and WebEx interviews. Up to 3 interviews (Manager & 2 x panel of 3 or 4 team members)