Sr. Manager / Associate Director of IT, R&D Systems

Company: Celldex Therapeutics, Inc.
Location: Fall River
Posted on: September 16, 2020

Job Description:

Sr. Manager / Associate Director of IT, R&D Systems in Fall River, Massachusetts | Careers at Celldex Therapeutics

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About us Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline includes antibodies, antibody-drug conjugates and other protein-based therapeutics derived from a broad set of complementary technologies which have the ability to engage the human immune system and/or directly inhibit tumors to treat specific types of cancer or other diseases.

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Sr. Manager / Associate Director of IT, R&D Systems in Fall River, Massachusetts | Careers at Celldex Therapeutics Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Returning Candidate? Log back in! Sr. Manager / Associate Director of IT, R&D Systems Job Locations US-MA-Fall River Overview The Sr. Manager / Associate Director of IT R&D Systems will be responsible to oversee and manage the portfolio of R&D and Manufacturing systems. She/He will work closely with IT colleagues, scientists, validation, QA, and vendors to ensure that lab systems and processes are operational and optimized to meet the needs of these groups, advise and recommend changes to systems, and ensure that changes to these systems follow company procedures, guidelines and regulations. Experience managing GMP or GLP lab systems, a solid understanding of GxP regulations, and excellent analytical, interpersonal and technical writing skills are required. This position will be based in Fall River, MA but may require occasional travel to other Celldex offices.

Responsibilities Oversee and manage portfolio of R&D IT implementation/upgrade projects and the change control process in a manner that is compliant with regulatory requirements and company policies and procedures.

Develop, review and update IT policies, procedures, and standards to assure regulatory compliance, data integrity, and operational efficiencies.

Provide primary IT support for all lab equipment software and GxP-regulated systems (primarily GMP and GLP, but may include GPVP and GCP), e.g. system administration, troubleshooting issues, software patches.

Act as liaison and collaborate with cross-functional team of internal stakeholders, IT consultants, and software vendors to make recommendations on new purchases, upgrades or updates to software or systems, and resolve system issues, while maintaining the validated state of computerized systems and data integrity.

Qualifications Have experience working in validated GMP environment

Have strong understanding of GxP regulations (e.g., 21 CFR Part 11, Annex 11), computer system validation, and SDLC

Possess excellent interpersonal skills, be diligent and self-motivated, with an eagerness to learn and excel in a high-paced environment

Strong analytical skills with demonstrated ability to solve complex problems, resolve deviations, and make realistic recommendations and plans

Strong technical writing skills and detail-oriented with the ability to thoroughly document processes, requirements, and write various technical and validation documents

Knowledge of various R&D computerized systems and willingness to learn new systems

Flexibility to adjust to changing priorities or timelines

Be willing to travel occasionally to other office locations in MA, CT and NJ

Education/Experience

Experience administering or supporting software and data management of various lab systems such as HPLCs, Plate Readers, Bioreactors, ELNs

5+ years of experience working in validated environment leading computerized system validation projects in pharmaceutical or biotechnology industry

Minimum of BA or BS in scientific field or Information Technology

Understanding of scientific processes a plus

Clean room experience a plus

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Keywords: Celldex Therapeutics, Inc., Fall River , Sr. Manager / Associate Director of IT, R&D Systems, Other , Fall River, Massachusetts