Associate Process Engineer

Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We consult in the pharmaceutical, biotechnology, medical device, and gene and cell therapy industries providing cGMP and industry best practices to our clients. We are an industry leader in providing project management, validation, engineering, quality/compliance, and consulting services to support finding ground-breaking treatments and solutions. Our clients include early-stage startups, established life science companies and CMOs / CROs. Our family-oriented culture strives to develop and leverage your interpersonal skills and technical experience for long term success.

Project Farma is a wholly owned subsidiary of Precision Medicine Group, LLC, a leading global life sciences company with over 2,000 employees headquartered in Bethesda, MD.

Purpose and Scope of Position
We have an exciting opportunity for an Associate Process Engineer working with cutting edge, early phase science and technology in the advanced medicine space. The Associate Process Engineer will support startup by ensuring that developmental experiments among small, medium, and large scale are executed as designed. This role will be responsible for phase-appropriate process development strategy and equipment operation. The Associate Process Engineer will work closely with the Research and Development, Manufacturing and Quality Systems teams to meet program milestones. The Associate Process Engineer will be responsible for organizing, running, sustaining, and continuously improving the manufacturing development operations at the plant/site. This role is located in Cary, NC.

Responsibilities of the Associate Process Engineer include but are not limited to:

• Serves as scientific and technical contributor for process-related issues and investigations at the laboratory
• Executes experimental procedures as detailed in developmental protocols
• Project management and planning for laboratory operations and experiments
• Owner's representative and manage vendors of equipment, systems, and services
• Produce pre-clinical material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs.
• Drafting of procedures, policies, forms, experimental protocols, and templates, creating process flows, charts, and data maps for process development
• Assists in documenting changes/updates to processing policies and procedures.
• Production planning and capacity models
• Approaches equipment and processing strategy development for manufacturing based on the science and process
• Supports tech transfer of new products and processes to ensure smooth transition to process development
• Conduct experiments supporting the development and implementation of a cell expansion, upstream, and downstream processes for gene therapy.
• Appropriately document experimental procedures and results according to established guidelines.
• Look for opportunities to implement operational excellence and continuous improvement
• Uses small-scale production processes and scaled-down lab processes to enable process troubleshooting.
• Completes requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.
• May work on special projects related to development and improvement of business and/or manufacturing processes

The successful Associate Process Engineer must have/be:

• BS in Engineering or related filed with a minimum of 2-3 years’ experience in biologics and/or cell culture in a GMP or laboratory environment
• Expert understanding and work habits compliant with pharmaceutical and biopharmaceutical unit operations.
• Capable of evaluating and summarizing data using analytical methodologies, interpreting results, drawing conclusions, and recommending options for future experiments to achieve project goals.
• Capable of identifying opportunities to implement operational excellence and continuous improvement
• Required knowledge, skills, and abilities to perform the tasks of an Associate Process Engineer to produce small-scale manufacturing batched
• Great soft skills, excellent verbal and written communication
• A proactive approach with clients to identify needs and work toward solutions that meet project scope, schedule, cost, risk, and quality expectations and requirements.
• Proven project and people leader with exceptional skills in planning, organizing, and history of driving and delivering successful results.
• Proficient with Microsoft Word, Excel, Project, with hands-on experience working in a corporate setting, and as a productive and supportive member of a project team.
• Demonstrate strong personal attributes that include: dedicated work ethic, teamwork, professionalism and the ability to see the "big picture"
• A full-time resident of North Carolina. This role is located in Cary, NC.

In return for your skills, knowledge, and passion, Project Farma offers a wide range of benefits including:

• Competitive salary based on experience
• Aggressive bonus structure to reward your commitment
• Paid Time Off
• Company laptop
• Health Insurance
• 401k plan with company match