Biogen has one of the most exciting pipelines in the Biotech / Pharmaceutical industry. The company has been growing rapidly and with this growth comes a number of exciting opportunities to work with our expanding business areas. One of these opportunities is to work in Pharmaceutical Operations and Technology (PO&T) to support the growing needs of the Quality IT organization. The organization is a lean and nimble work environment where people have the latitude to lead coupled with a highly collaborative focus and significant opportunities

Overview

The PO&T IT Quality Systems and Lab Automation group focuses on Application management in support of the Quality Assurance and Quality Control groups across Biogen Operations.    The group works with the business, the Enterprise architecture group, and application vendors to ensure application availability, business relationship management, and project implementation.

Business Analyst (BA) to deliver high-quality requirements in a project or in the management of systems. This position will be a business facing role focused on ensuring compliance of the current systems for data integrity, audit readiness, and working with the business to assess new systems vs corporate standards and regulatory expectations. 

The span of the position includes but may not be limited to, Quality Assurance/ Quality Control laboratory and enterprise systems as well as manufacturing applications  
 

The individual will:

• Work in a team and serve as tactical IT liaison to the business through building and fostering a partnership.
• Demonstrate strong understanding of the business area and its supporting technology as well as broad understanding of overall business unit.
• Ensure solution delivery meets business need and expectation through business requirement gathering.
• Gather and validate business needs to translate into requirements for technical team.
• Work with technical teams to develop technical requirements and solutions.
• Be proactive in identifying solutions or opportunities that can help improve Business processes.
• Be point of contact for business focused application questions and be able to identify and leverage resources across IT
• Model and enhance business process diagrams and other related models to capture business operations change requirements within defined opportunities or projects, modeling both current and future state, typically using a graphical BPA or business process modeling tool.
• Document or map business processes targeted for change via approved projects, both current and future state. Determine and document the impact of process changes for the process owner.
• Define the needed business cases with project team and process owner, defining business outcomes, including current baseline and future target metrics, such as leading and lagging indicators, and linking to strategic key performance indicators (KPIs). 
• Document business requirements for system enhancements and collaborate with IT to ensure effective development and testing needed for successful solution deployment.

Business partnership and technology expertise

• The Ideal candidate will have demonstrated experience in laboratory, quality, and business process and systems leadership as it relates to compliance with regulatory and corporate expectations and guidelines
• The ideal candidate will be able to demonstrate a successful track record of assessing systems against corporate and regulatory requirements and driving change to ensure compliance in a GxP environment
• The ideal candidate will be able to demonstrate a successful track record developing processes, SOP’s, systems to support applications and equipment in a GxP environment
• Demonstrate strong understanding of data integrity, quality, and change management processes in a GxP, regulated environment.
• Strong understanding of the Quality, Manufacturing, Regulatory and/or Supply Chain business areas and their supporting technology as well as broad understanding of overall business units a plus.
• Be point of contact for business focused application questions and be able to identify and leverage resources across IT.

Impact

• In collaboration with the business customer, utilizes broad business knowledge to proactively search for strategic technological solutions.
• Exerts some influence on the overall objectives and long-range goals of the business area.
• Builds and manages peer and management-level business relationship through achievement of results, accountable to schedule, and allocation of resources and meeting customer needs.

Scope

• Collaborates cross functionally to driver initiatives to a successful conclusion.

Decision Making  

• Identifies and recommends process improvements.
• Demonstrates ability to identify issues, independently resolves routine issues, escalates more complex issues to a higher level.

Knowledge

• In depth knowledge of business functional area with strong understanding of business unit (Or if new to business area, shows strong learning agility to achieve in depth knowledge).
• Understands the technology offerings applicable to the business when assisting in the design of solutions.

Minimum Requirements:

• B.S. degree (in science, engineering or business), with related business discipline experience. M.B.A. or other advanced degree in business or social sciences is a plus

Minimum Experience Requirements:

• Experience with life sciences systems within the Biotech/Pharmaceutical industry.
• Multiple years of process improvement experience (depending on skill level — more time for advanced skills and commensurate salary), especially experience that leverages technology as part of the solution.
• Manufacturing or laboratory experience with thorough knowledge of GxPs.
• Highly technical LIMS experience – knowledge of LabWare LIMS is a must, with at least v6 – preferably LabWare v7 experience.  Knowledge of ELN is desirable, preferably experience with LabWare ELN v2 or higher.  The candidate should have specific experience with basic LabWare LIMS configuration and experience.
• Requirements analysis / gathering.  The candidate should be capable of connecting LabWare LIMS / ELN out-of-the box capabilities with laboratory business processes and able to conduct highly detailed discussions with both laboratory scientists and IT technical teams.  The candidate should be able to offer both modifications to the technical configuration and business process in order to achieve a suitable system, utilizing SDLC, Waterfall, Agile or similar. 
• Knowledge of Laboratory business processes – the candidate should have documented experience with laboratory business processes – Biotech/Pharma is preferred.  The candidate should have general knowledge of Chemistry, Biology, and Microbiology laboratory processes. 
• Good interpersonal, verbal and written communication, including good presentations.
• Strong analytical and conceptual skills.
• More interested in business results than personal preferences, and in group rather than individual achievement.
• Ability to work within high-performing virtual teams and is highly collaborative.
• Builds excellent relationships with key internal and external customers based on trust and confidence.
• Minimum travel both domestically and internationally.

Business Analyst (BA) to deliver high-quality requirements in a project or in the management of systems. This position will be a business facing role focused on ensuring compliance of the current systems for data integrity, audit readiness, and working with the business to assess new systems vs corporate standards and regulatory expectations. 

All your information will be kept confidential according to EEO guidelines.