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4 days old

Cell Therapy Manufacturing Manager

Kelly Services
Waltham, MA 02454
Kelly Scientific is seeking a direct hire Cell Therapy Manager near Waltham, MA.



Relocation assistance provided!



Competitive salary and great benefits!



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 companys 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 companys 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-first time 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





Qualifications:




+ 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 & Clinical 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/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.
Posted: 2020-09-14 Expires: 2020-10-15

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Cell Therapy Manufacturing Manager

Kelly Services
Waltham, MA 02454

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