Sr. Director, IT Cell Therapy
: Job Details :

Job Title: Sr. Director, IT Cell Therapy (Direct Hire - FTE)Location: Devens, MA 01434Position Summary:The Sr. Director, Cell Therapy Devens Manufacturing Site IT Lead position plays a critical role in managing all corporate & locally supported infrastructure and software at the Devens, MA Cell Therapy manufacturing site. We are seeking a highly skilled and experienced IT Platform and Product Manager to oversee the IT operations at our manufacturing site. The ideal candidate will be responsible for designing, managing IT platforms, ensuring seamless integration and functionality, and driving product development initiatives. This role requires a strong understanding of manufacturing processes, IT infrastructure, and the ability to collaborate with cross-functional teams to deliver innovative solutions. The role must excel at supporting the site's daily operations while also developing a strategic IT roadmap for the site. This role will work closely with executive leadership and other key stakeholders to support the organization's growth and success.This role will report to the Executive Director, Digital/IT - Cell Therapy Manufacturing Operations and will also be part of CTGM IT Leadership Team.Duties and Responsibilities:Lead a matrixed organization composed of both site direct reports and groups of indirect reports to deliver effective, innovative and stable solutions that meet the needs of the site. Lead, mentor, and develop a high-performing IT team, fostering a culture of innovation, collaboration, and continuous improvement.Active member of the Cell Therapy Site Leadership Team (SLT). Collaborate with site leadership to develop, support, and align strategies for business process improvements through information systems automation.Function as the liaison and the single point of contact between site leadership and corporate IT.IT Platform Management:Oversee the development, implementation, and maintenance of IT platforms to support manufacturing operations.Ensure the integration and compatibility of various IT systems and platforms.Monitor and optimize platform performance, reliability, and security.Product Management:Lead the product development lifecycle, from concept to launch, for IT solutions supporting manufacturing operations.Collaborate with stakeholders to define product requirements, prioritize features, and create product roadmaps.Conduct market research and competitive analysis to identify opportunities for innovation and improvement.Project ManagementPlan, execute, and manage IT projects, ensuring they are delivered on time, within scope, and within budget.Identify and mitigate project risks and resolve issues as they arise.Track project progress and report on key performance indicators (KPIs).Develop and implement comprehensive IT strategies that support the organization's business objectives and growth plans. Ensure the IT applications can support the current and the expected future patient capacity.Oversee the development and management of the IT budget, ensuring alignment with financial goals.Accountable for continuous operation, maintenance and improvement of process automation systems, MES, LIMS, application integrations, local manufacturing, quality control and quality management site IT systems as well as associated site infrastructure.Lead Cell Therapy site service level management scope and process with IT groups and/or vendor managed services, i.e. Service Level Agreements (SLA's), Disaster Recovery/Service Continuity, etc.Provide IT leadership to site regulatory inspection readiness and data integrity initiatives.Participate in high-level strategic communications with the business and site leadership teams.Ensure the reliability, security, and scalability of the organization's IT infrastructure, including networks, servers, and storage systems. Oversee the implementation and maintenance of disaster recovery and business continuity plans.Manage new demand from the various site functions (Manufacturing Operations, Quality, Supply Chain, Manufacturing Science & Technology) through the IT stage gate process.Identify key technology trends and how new technologies might be leveraged to provide better solutions to the manufacturing site.Negotiate and manage contracts with IT vendors, service providers, and consultants.Qualifications & ExperienceBachelor's degree in an Information Technology, life sciences or engineering discipline (Master's Degree preferred) or a minimum of 12 years of equivalent biotechnology or pharmaceutical industry experience.Proven experience in IT platform management, product management, and manufacturing site IT operations.Extensive experience in a senior IT leadership role, with a proven track record of successful IT strategy development and execution preferably within a pharmaceutical technical operations environment. Experience should range from manufacturing and quality control systems to GxP quality management systems.Demonstrated Strong leadership and team management skills, with the ability to inspire and motivate a diverse team.Excellent project management skills, with the ability to manage multiple projects simultaneously.Strong analytical and problem-solving skills.In-depth knowledge of IT infrastructure systems, change management, staff mentoring, performance evaluation, life-long learning, and diagnosis of sources of problems in both technology and business processes.Deep knowledge of regulatory requirements in the areas of current Good Manufacturing Process (cGMP).Understanding of regulatory requirements and the role technology plays in satisfying those requirements is essential to this position.Thorough understanding of best practices in SDLC and ITIL.Effective communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels. Must be client service-driven with excellent relationship management and analytical skills.MES, Automation, IT Quality & Compliance, Enterprise System Integrations, IT infrastructure and IT Lab Systems experience preferred.Role Responsibilities:Lead the Digital Plant team (30-35 employees), ensuring all systems are automated for manufacturing execution in a cell therapy environment.Participate actively in leadership, including daily tier meetings with site heads and VP of Cell Therapy.Ensure high urgency around issue resolution, especially in critical patient-related processes like Apheresis.Oversee the integration and smooth operation of the Manufacturing Execution System (MES) and other automated systems, including Syncade, Delta V, SAP, LIMS, and Maximo.Manage stakeholder relationships and prioritize effectively between Enterprise IT and site leadership to prevent team overload.Requirements:Strong experience with MES (Manufacturing Execution Systems), preferably Syncade or similar, and process automation.Background in cell therapy or regulated manufacturing environments, with understanding of continuous improvement processes.Familiarity with digital platforms, especially within IT and manufacturing (MES, LIMS, Delta V).Ability to handle high-stakes priorities, balancing patient-centric decisions with operational demands.Proficiency in stakeholder management, navigating pressure from both Enterprise IT and site leadership.Qualifications:Bachelor's or Master's degree in Engineering or Information Technology, with preference for Engineering backgrounds.Experience in IT Operations within a manufacturing environment.Senior IT leadership experience is beneficial but not mandatory.About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of human connection, defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at ...@spectraforce.com if you require reasonable accommodation.California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act ( CPRA ) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting ...@spectraforce.com.LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.