IT Manager Scientific and R&D Systems

Alkermes

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Location: Waltham, MA Posted Date: 4/11/2013 Position Type: Full time Job Code: 4652 Required Education: High school or equivalent

Description

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, Wilmington, Ohio and Gainesville, Georgia. For more information, please visit Alkermes website at www.alkermes.com.



POSITION SUMMARY:


Alkermes is seeking a seasoned IT Manager with a complimentary Scientific Laboratory and Pharmaceutical Research & Development (R&D) background for this role. The IT Manager will be a key member of the IT management team that will serve as the primary liaison between the IT organizations and the Scientific/R&D  Departments  with responsibility for all aspects of IT applications management.  In addition, this individual will lead and manage related business and systems initiatives, from a technical perspective.


The role will be based in Waltham MA.

 


ESSENTIAL AREAS OF RESPONSIBILITY:    


*  Plan, manage and evaluate the work of a team of application support personal, ensuring the team is complying with defined service level agreements by aligning technical skills with business requirements.

*  Ensure appropriate IT processes, procedures, and standards are in place.

*  Participate in the development of IT strategies and evaluation of new technologies/functionality by overseeing the planning, analysis, design, selection, installation and implementation of new technologies.

*  Build and foster effective relationships between the business and IT.

*  Oversee vendor relationships.

*  Actively contribute to annual planning and budgeting processes.  Monitor budget-to-actual performance for key projects and strategic initiatives.

*  Participate in company initiatives/projects that require business application support while keeping in line with overall IT project roadmap.

*  Effectively manage projects using best practices and following required Systems Development Life Cycle (SDLC) policies.

*  Coordinate issue resolution with internal and external technical support providers.

*  Introduce best practice and process improvement ideas wherever appropriate.

*  Ensure adherence to FDA computer systems validation compliance (GXP, GLP, GCP) and Sarbanes-Oxley (SOX) controls.  Execute and review ongoing compliance activities as required.

*  Ensure adherence to company's policies and procedures.


QUALIFICATIONS:


Minimum Education & Experience Requirements:


*  Bachelors Degree in Computer Science, Information Systems, or a related field; or Bachelors Degree (or equivalent) in Biology, Chemistry, Biochemistry, or a related field

*  Project Management Institute (PMI) certification a plus.

 

Experience:


*  Experience within pharmaceutical/biotech industry  

*  Must have a proven track record to lead a small-to-mid-sized team.

*  Must have solid application management experience working in a global environment.

*  At least 5 years experience supporting pharmaceutical lab, scientific, clinical, and/or R&D systems and software implementation, including experience supporting a GxP environment

*  Experience with enterprise information management systems and software vendor selection.

*  Familiarity with deployment and support of Waters Empower and Scientific Data Management Systems (SDMS/NuGenesis) and Vision Publisher is a plus.

*  Experience supporting Electronic Data Capture and E-Notebook implementations for a scientific R&D group is a plus.

*  Familiarity with a variety of laboratory instruments and corresponding software tools.

*  Demonstrated ability to manage several complex projects at the same time.


Technical Knowledge/Skills Needed:



*  Familiarity with research informatics, bioinformatics, cheminformatics, statistics.

*  Knowledge in Electronic Laboratory Notebook systems (e.g., CambridgeSoft E-Notebook, Waters SDMS/Vision Publisher, IDBS E-WorkBook) preferred.

*  Knowledge of GxP requirements and associated guidelines

*  Demonstrated Project Management skills. PMI or equivalent certification preferred.

*  Demonstrated business processes improvement capabilities.

*  Exhibits strong teaming skills, including facilitating group sessions and reaching consensus across multi-site global teams to deliver cross-functional projects.

*  Strong project management skills



Personal Attributes Needed:



*  Ability to multitask effectively manage simultaneous work requests across Finance, IT and other organizations, in various geographies.



*  Strong work ethic, with a proven track record in successfully achieving goals.

*  Ability to initiate, persuade and influence others on the best solutions to action.

*  Solid communication (verbal / written) and organizational skills and a strong professional presence.  Ability to develop effective communication based on target audience.

*  Self-starter with the ability to work on projects with minimum supervision while adding value to cross-functional teams.

*  Ability to manage under a straight and dotted line scenario.



Travel Requirements:


*  Occasional business travel expected domestically (e.g. Ohio, Georgia) and internationally (e.g. Ireland).


Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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