Work Location: Gaithersburg, MD
Job Title: Engineering Project Manager
Duration: 6 Months (Temporary/Contract)
Kelly Services is currently seeking an Engineering Project Manager for one of our top clients in Gaithersburg, MD.
Opening for an Engineering Project Manager in Gaithersburg, MD. We are seeking a highly motivated upstream tech transfer and manufacturing support professional. This position will be responsible for transfer of upstream processes from development into clinical/commercial manufacturing at internal sites or CMOs. Members of the tech transfer function within this department work closely with the process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to manufacturing production.
• Routinely transfer multiple projects as upstream tech transfer representative including fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, campaign summary report authoring, and routine presentations to cross-functional teams and management
• Lead cross functional teams making business process improvements or implementing new technologies/approaches
• Builds and maintains relationships with partner groups
• Proactively addresses risks/issues and influence process development to avoid non-conformances and enable efficient transfers
• Represent function on cross-functional teams
• Participate in design or analysis of lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances
• Provide input on process development strategies
• Write technical reports and deliver presentations
• Contribute to the improvement of the tech transfer business processes through idea generation, team leadership, and implementation
• Cell culture tech transfer and/or development experience
• Hands on experience with bioreactors (bench, pilot or production scale)
• Fundamental understanding of upstream unit operations such as mixing, bioreactor, centrifugation, and filtration.
• Working knowledge of the scale-up/scale-down principles of cell culture or fermentation processes
• Experience with primary clarification via continuous centrifuge
• Knowledge of GMP manufacturing principles and documentation
• Skilled in root cause analysis and problem-solving
• Demonstrated critical thinking skills
• Excellent written and verbal communication skills
• Sound decision making with limited data and guidance
• Demonstrated ability to outline issues, assess and present risks/benefits, and ability to make recommendations using sound scientific reasoning
• Skilled in effectively explaining complex scientific or engineering concepts to a broad and diverse cross-functional audience.
• Experience with being an effective and influential contributor and leader to projects governed by matrix teams
• Demonstrated initiative and drive for results
• Demonstrated ability to stand in the face of strong/higher level opposition
• Must be able to work independently
• Experience with data and statistical analysis
• Proven experience in preparing detailed and thorough technical protocols and reports
• Knowledge of the drug development process, global regulations, process validation and ICH guidelines
• Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
• Fermentation or viral based production experience
• Prior experience leading projects outside of area of technical expertise
• Skilled in conducting complex transfer/process development/technology development projects
Position Requirements Supervision
This position will not have any direct supervisory responsibilities.
A Bachelors, Masters or PhD Degree in an engineering or scientific discipline with a focus in a process engineering field (e.g., chemical or biochemical engineering) is strongly preferred.
The candidate must have industry related experience (BS 6+, MS 4+, PhD 4+ years).
Additional Notes Position requires periodic weekend work and/or periodic late night work. Position may require some travel to CMO or other sites (domestic and international).
As a Kelly Services employee, you will have access to numerous perks, including:
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]]