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LabAnswer

LabWare LIMS Project Manager

Posted One Month Ago
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In-Office
Boston, MA, USA
Senior level
In-Office
Boston, MA, USA
Senior level
Leads IT project management and user acceptance testing for LabWare LIMS implementations and laboratory systems validation projects. Responsibilities include requirements gathering, vendor coordination, system upgrades, SOP and UAT script development, data migration, SDLC documentation, qualification, deployment, training, and regulatory compliance with FDA, CAP, CLIA, and GMP requirements. Provides strategic direction across IT, scientific, and management teams in pharmaceutical and other regulated laboratory environments.
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Company Description

LabAnswer is the leading and largest laboratory informatics consultancy; combining science, laboratory, regulatory and information technologies. We have the people, processes, methodologies, IP and experience to deliver comprehensive laboratory informatics solutions.

LabAnswer has architected, implemented, deployed and/or supported hundreds of major scientific informatics systems across more than a thousand laboratories. LabAnswer performs significant laboratory automation work in pharmaceuticals, bio-pharmaceuticals, medical devices, forensics, and life sciences research laboratories spanning research, development and manufacturing/QC operations.

The LabAnswer team has a rare combination of laboratory science, IT, business and regulatory expertise. We specialize in helping companies strategize, architect, implement and support scientific data management and laboratory automation projects.


Job Description

At LabAnswer, we are looking for a leader to provide IT Project oversight for a laboratory systems validation project . This person must have at least 5 years of Project Management experience with managing LabWare LIMS projects. 

Job Requirements

•Serve as a IT Project Management and UAT resource for a LabWare LIMS implementation. 

•Set priorities for problem resolution 

•Develops relationships with vendors and 3rd party consultants 

•Communicate pertinent system information to site/project leadership as needed 

•Identify, document and communicate new site business requirements. 

•Coordinate implementation of new functionality or upgrades 

•Maintain a communication process with the other sites to maximize resource usage. 

•Maintain system related SOPs and create UAT scripts

•Assist in working with business to identify data needs in new LIMS system 

•Provide strategic direction to the IT, Scientific, and Management teams based on combination of industry and technical knowledge 

•Assist in defining data migration requirements 

•Assist in creating and maintain SDLC documentation 

•Assist in working with Development team to implement and test accuracy and completeness of data migration 

•Contribute in all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training 

•Work with project teams to ensure compliance with regulatory requirements such as FDA, CAP, CLIA, as well as internal policies and processes 

•Identify the optimum combination of applications that meet the requirements of disparate laboratory and business functions 

Qualifications

A qualified candidate will possess: 

•Knowledge of LabWare LIMS

Experience with managing a laboratory systems validation project in a Pharmaceutical/R&D environment 

•Excellent verbal and written communication skills 

•Expert understanding of GMP 

•Demonstrated experience implementing enterprise data capture/management technologies 

•Ability to contribute to multiple projects for different business stakeholders 

•Experience implementing technology under a defined corporate and compliant methodology 

•Expert understanding of computer and application architecture, technology, and validation

•Strong analytical and problem solving skills 

Education: 

Bachelor Degree in a related discipline and five+ years of project management, systems implementation and analysis experience. Emphasis should be on laboratory tools for R&D or Quality groups of an FDA regulated environment. 

Additional Information

We offer comprehensive benefits to regular fulltime employees including but not limited to:

•Unlimited ceiling for professional growth opportunities within LabAnswer

•You will also have opportunities to take advantage of training programs to advance your career; our extensive online library includes an assortment of technical and professional training tools and resources

•Opportunities to work across a variety of industries (Pharmaceutical, Medical Device, Consumer Products, Energy, Environmental, Forensics, Genomics, Government etc.)

•Opportunities to work across a variety of laboratory environments (analytical testing, biotech, clinical trials, forensics, medical device, pharmaceutical, public health and research hospitals)

•Comprehensive health and welfare programs to fit your individual or family’s needs:◦Health Insurance

◦Dental Insurance

◦Vision Insurance,

◦401(k) Retirement Saving that includes a generous employer match

◦Paid Time Off (vacation, sick, holiday)

◦Company Paid Life Insurance

◦Company Paid Short and Long Term Disability Insurance

◦Wellness Plans and Rewards

◦Strong company values of team work, culture and values, personal and professional development, work-life balance, and recognition

◦Competitive compensation with opportunities to participate in employee bonus plan and travel bonus plan

 At LabAnswer we offer a very competitive compensation package based on experience and education. We are looking for exceptional people to join our team, those who are looking to join an organization for the long term. We invite you to visit www.labanswer.com to review our Employee Value Proposition and Philosophy, and welcome you to apply, or refer a candidate to apply, through our careers page for employment consideration.

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