Website Goodwin Biotechnology
Scope of Function:
As a key member of the Goodwin Biotechnology team, you will be developing and managing IT infrastructure within a biopharmaceutical CDMO – contract development & manufacturing organization. The IT systems (cloud, software and hardware) are specifically tailored to meet Goodwin’s business and operational needs and involve a knowledge of and compliance to specific requirements for the pharmaceutical industry.
Reports to: Sr. VP of Operations
- Partner with senior management in the planning, development and implementation of currently ongoing IT projects for the Organization. These include incorporating information technology into various facets of our business including finance, operations, facilities, quality, marketing and other areas.
- Manage the deployment, monitoring, maintenance, development, upgrade and support of all IT systems, including telecommunications, servers, PCs, operating systems, hardware, software, peripherals, as well as office automation and process equipment with the support of our IT vendors.
- Benchmark, analyze, report on, and make recommendations for the improvement and growth of the IT infrastructure and IT systems.
- Develop and implement all IT policies and procedures, including those for architecture, security, disaster recovery, standards, as well as purchasing and service provisions in compliance with required standards.
- Negotiate and administer vendor outsource, consultant contracts, and service agreements.
- Operate and maintain systems such as Active Directory, Microsoft Exchange, and Microsoft Teams.
- Managing and continuously developing an infrastructure where data integrity is critical.
- Creating and managing an operating budget for the department.
- Requires a technical degree (A.S., B.S) in Information Technology and/or Information Systems. Masters’ degree is a plus. Certifications (A+, N+, Server+, MCSE/MCSA/MCITP) also a plus.
- 5+ years of relevant experience along with network administration and information technology business experience, IT architecture and design, as well as enterprise resource planning systems.
- Any experience with FDA regulated environment/organization, preferably pharmaceuticals or medical devices is preferred.
- Knowledge with scientific labs and GMP equipment is highly preferred. Familiarity with 21CFR211 and other computer system validation regulations are highly desirable.
- Familiarity with some or all of the following systems is a plus: NetSuite, Salesforce.com, Electronic Quality Systems, Laboratory Information Systems.
- Meticulous, conscientious, analytical, objective-driven individual who is a quick learner and passionate about her/his work.
- Excellent communication skills – both verbal and written.
- Previous managerial experience is a plus.
- Bilingual preferred. (Spanish/English)
- All Departments