(Sr.) Manager, GMP IT System - Biopharmaceuticals

AbelZeta Inc. is a clinical-stage biopharmaceutical company focused on the development of novel immunotherapy products. AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms and a QC laboratory in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer and autoimmune disease patients. 

We are seeking a (Sr.) Manager, GMP IT System, to join our team. He or she will play a pivotal role in establishing and maintaining GMP Computer System, Data Integrity and Compliance and network security procedures. This role will be also responsible for managing the day-to-day IT operations activities. 

Responsibilities and Duties:

• Design, implement, and maintain GMP IT system infrastructure.
• Manage day-to-day IT operations, partnering with vendors for support and ensure office internet/wifi reliability.
• Set up and administration of lab instruments (including implementation of active directory, setting up user groups, user access, configuring systems, etc)
• Identifies and implements software, hardware, and cloud solutions for data backup processes and other processes as needed
• Build and maintain business continuity and disaster recovery strategies to minimize downtime and ensure rapid recovery of critical systems
• Work with internal partners to understand strategy and business challenges to proactively recommend IT solutions and to deliver key programs and projects for the site.
• Ensure compliance of company IT operations with the regulations and standards including but not limited to data security.
• Provide IT support for computer system validation (CSV) to ensure data integrity per FDA  regulation.
• Works with Quality department to present change plans, change actions, and close assigned workflows
• Assist with SOP generation as needed including, but not limited to, administration SOPs and access management procedures
• IT suppliers management: overseeing the selection and onboarding of IT suppliers, monitoring performance metrics and cost, etc
• IT fix assets management: tracking inventory of hardware, software, and network components and optimizing asset utilization to reduce costs and prevent redundancy, etc.
• Other duties as assigned. 

Qualifications and Requirements:

• Bachelor’s degree in technology, engineering or computer science
• At least 5 years of relevant and progressive experience driving process improvement and systems implementations and leading projects from design, development to implementation of IT solutions.
• Familiarity with cell therapy laboratory instrument software, such as FACSLyric
• Experience in biotech, pharma or life sciences manufacturing and lab with an understanding of what is required in a GMP environment is a must.
• Expertise with implementing, configuring, and testing solutions.
• Knowledge of 21 CFR Part 11, Annex 11, GAMP5, data integrity, and Computer systems Validation process 
• Experience in the life cycle management of computerized systems, including but not limited to: operation, change, upgrade, migration, file archiving, periodic review, retirement management, etc. 
• Experience in the internal and external audit support of computerized systems 

Key Attributes

• Self-starter with a go-getter attitude and the ability to proactively identify and solve problems.
• Highly motivated with a strong sense of ownership and accountability.
• Strong communication skills to effectively support both technical and non-technical users.
• Empathetic and professional approach, with the ability to remain calm and supportive under pressure.
• Team-oriented with the ability to collaborate across office and lab functions.

Why You Should Join AbelZeta

• Join a high-growth and fast-paced organization.
• Defined career path and annual performance review and feedback process.
• Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more!
• Competitive company 401k match.
• Paid holidays, sick leave, and annual leave.

AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.