Manager/Sr. Manager, Analytical Laboratory Database Management

Adicet is developing the next generation immunotherapies by generating a pipeline of allogeneic gamma delta T cell products engineering with CAR or TCR. In addition,
Adicet's immune cell platform is complemented by its ability to identify and validate novel disease specific peptide-MHC targets and generates T cell receptor-like antibodies directed against these disease-specific peptide MHC complexes.

Adicet Bio was founded in late 2015 with significant investment from OrbiMed, Novartis Venture Funds and Pontifax. In August 2016, Regeneron and Adicet Bio announced a strategic collaboration to discover and develop next-generation engineered immune-cell therapeutics and in September 2016, Adicet Bio was recognized and named by FierceBiotech as a "Fierce 15" Biotech Company of 2016.

MANAGER/ SENIOR MANAGER ANALYTICAL LABORATORY DATABASE MANAGEMENT:

Adicet Bio is seeking an experienced professional to work in the Quality Control (QC) and CMC Analytical Operations Department. In this position, the individual will establish and manage a central database of the experimental, analytical and quality control data generated by internal R&D groups as well as by external contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs). The individual will ensure compliance with company policies and procedures as well as applicable regulatory and industry standards for data recording, integrity and storage.

KEY RESPONSIBILITIES

• Build, establish and manage a central data base and data management system for experimental, analytical and quality control data generated by internal R&D groups as well as by external CMOs and CTLs.
• Coordinate with internal Analytical Development, Process Development, Research, IT and external consultants to establish and enable a suitable scalable and compliant analytical laboratory data base and data management system.
• Compile and maintain appropriate SOPs and other documentation to ensure compliance of internal staff and external providers for compliant data entry, review, analysis and integrity.
• Establish and execute a documented program to train staff on the use of the database.
• Collaborate with relevant groups to assist in the compilation of regulatory filings and reports.
• Other as may be assigned.

QUALIFICATIONS:

• Bachelor of Science degree in Computer Sciences, Immunology, Analytical Chemistry or related field.
• A minimum of five years of experience in computer programing and laboratory data management systems in GMP compliant environments with data integrity requirements.
• Must have previous experience with the implementation, validation and maintenance of relevant laboratory data processing/ data management software such as Electronic Note Book (Benchlink), LabKey or similar system.
• Experience in CAR-T, gene/cell therapy, antibody or viral vector companies a plus.
• Ability to work independently, multitask and meet deadlines in a fast-paced environment.
• Highly motivated, organized and disciplined record keeping; strong attention to detail.
• Excellent verbal and written communication skills.

BENEFITS:

Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.