12 days old

Viral Vector Operations Manager

Kelly Services
Waltham, MA 02454
Viral Vector Operations Manager - Waltham, MA area

**The Role:**

Kelly Scientific is looking for a dynamic engaging leader for one of our clients viral vector cGMP manufacturing operations. The individual will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of viral vector manufacturing including upstream, downstream, fill finish, manufacturing support and, contribute to on-time-delivery of manufacturing operations for The companies multiproduct cGMP gene and cell therapy site. The incumbent will be responsible for a diverse manufacturing team performing routine cGMP manufacture of viral vectors supporting gene and cell therapy products including Adeno-Associated Virus (AAV) and Lentivirus (LV) at our state-of-the-art facility and provide leadership across both viral vector and cell therapy 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.

**Heres What Youll Do:**

+ Be integral in providing hands-on technical, organizational, and leadership expertise to the start-up activity for The companies 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 viral vector manufacturing processes

+ Engage in proactive relationships with partners including acting as key client interface representing The companies 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


+ Bachelors degree in biological science(s) field or related engineering, M.S. preferred

+ 6-10 years of experience in cGMP biotech manufacturing

+ 6-8 years of viral vector 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 of AAV, LVV, RV, using equipment such as incubators, single-use bioreactors, fixed-bed bioreactors, chromatography skids, hollow-fiber and/or flat-sheet TFF

**Physical Requirements:**

+ Employee will frequently stand, walk, bend, stretch for extended periods

+ Routinely carry up to 25 pounds and up to 50 pounds

+ Routinely push, pull, bend, kneel, twist, and climb step ladders while wearing PPE

+ Routine repetitive use of arms/wrist/hands

+ Ability to work nights, weekends, holidays as needed to support business needs

+ Ability to don job-specific PPE

**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: 2020-09-07 Expires: 2020-10-08

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Viral Vector Operations Manager

Kelly Services
Waltham, MA 02454

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