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1+ months

Cell Therapy Manufacturing Manager

Kelly Services
Waltham, MA 02454
**Kelly Scientific is seeking candidates for a Cell Therapy Manufacturing Manager position with our innovative and dynamic client in the Waltham, Massachusetts area!**

Summary:

The individual will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of cell therapy manufacturing and, contribute to ontime-delivery of manufacturing operations for the multiproduct cGMP cell and gene therapy site. The incumbent will be responsible for a manufacturing team performing routine cGMP manufacture of a diverse portfolio of autologous and allogenic cell therapies and provide leadership across both cell therapy and viral vector manufacturing. The individual should be a motivated self-starter eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise, have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards.


Responsibilities:

Be a cell therapy technical expert for cGMP manufacturing and aseptic processing



Be integral in providing hands-on technical, organizational, and leadership expertise to the start-up activity for a state-of-the-art cGMP cell and gene therapy manufacturing facility including but not limited to equipment selection, SOPs, batch records, reports, risk assessments, material ordering/management



Provide daily management oversight of products production flow / value stream ensuring end to end the internal supply chain delivers product timely and right-first-time, stalwart adherence to driving culture that improves operational and quality metrics



Work with a cross-functional team of process development, engineering, quality, etc. for the development of cGMP-appropriate, scalable cell therapy manufacturing processes



Engage in proactive relationships with partners including acting as key client interface representing operational interests in both tactical and strategic meetings



Lead operational staff, develop staff capabilities, create a culture of safety, continuous improvement and training objectives, and compliance



Establish key performance indicators in alignment with individual, department, and company goals, maintain and report organizational metrics



Proactively identify and escalate key risks and issues to manufacturing line and site leadership team. Organize and lead ad hoc cross functional teams to develop risk mitigation plans and/or manage complex operational issues



Work effectively with cross functional teams comprised of process sciences, development, facilities & engineering, tech ops, quality control, quality assurance, to ensure right-firsttime technology transfer

Identify risks and propel continuous improvements in development and manufacturing processes through technological innovation and alignment with regulatory requirements for clinical and commercial vector manufacturing



Ensure high levels of communication with team, support resources, and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.



Works closely with the production staff to troubleshoot process and equipment problems



Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives



Support the team in defining and executing technical strategies



Work closing with Quality Assurance and Process Sciences to proactively resolve issues such as deviations, CAPAs, Change Controls



Review completed batch records. Develop training material, update curricula, close training gaps, and support the initial and ongoing training of staff



Proactively identify opportunities for improvements in process, safety, quality, and cost


Requirements:



Bachelors degree in biological science(s) field or related engineering, advanced degree preferred



6-10 years of experience in cGMP biotech manufacturing



6-8 years of cell therapy manufacturing experience



4-6 years of project owner/management experience



4-6 years of proven leadership experience



Experience with MES and integrated automation in manufacturing preferred



Outstanding communication skills (verbal and written)



Excellent computer and word processing skills including Microsoft Excel, Powerpoint, and Word



Experience with some or all of the following; cGMP manufacture and/or process development for CAR T, TCR, NK, cellular therapies



Advanced understanding of primary cell culture and experience with equipment such as CliniMACS, CliniMACS Prodigy, LOVO, WAVE bioreactors such as Xuri, G-Rex system



























**Why Kelly** **** **?**



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-04-15 Expires: 2020-07-16

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Cell Therapy Manufacturing Manager

Kelly Services
Waltham, MA 02454

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