Stability LIMS Systems Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Shift: Full-Time; Monday – Friday; 8am-5pm EST

ONSITE:

This is a fully onsite role based at our customer’s site in Devens, MA or New Brunswick, NK. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.  

Must be legally authorized to work in the United States without sponsorship. 

Must be able to pass a comprehensive background check, which includes a drug screening. 

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Position will support  future state stability work stream for the integration of storing business processes and programs through modification and generation of LIMS elements and components.  The position is designed for direct interaction and support of the stability programs in support of ongoing operations, current and future program and system integrations, and immediate troubleshooting.  In order to effectively support the stability end users, this role will need to generate comprehensive user requirements, understand the associated LIMS elements, and be able to identify and assess overall impact to operations.  This role will require participating in future state process determination and  have responsibility  toward identifying areas of alignment to the system.  This is a highly collaborative role that requires a strong sense of stability understanding in order to drive the right end user outputs. As required to support ongoing activities, this role may include storing the stability study management and current state LIMS activities.

Key responsibilities:

• Support the Senior Manager in identification, documenting, and driving commercial stability user requirements for a future state LIMS system
• Serve as a point of contact for the stability user group in order to liaise with business and process owners and direct management, with the intent on developing, managing, and executing stability strategies related to the future and current state LIMS systems.
• Serve as a technical expert within the Sample Manager LIMS and Labware systems in order to support mapping multiple current state LIMS processes to a singular future state, centralized LIMS system
• Support static builds, migrations, and system updates to enhance current stability operations for critical ongoing Run-the-Business requirements
•  Support and or manage user ticket requests to ensure available stability support and completion.
• Execute and/or manage completion of UAT (for functionality changes)
• Training stability personnel on LIMS system usage
• General LIMS user support and initial/basic troubleshooting
• Maintain and operate within cGMP requirements, including maintaining training status.
• Perform stability scientist duties, as needed (e.g. stability submission and program strategies, stability protocols, trending, managing product requirements)
• Perform against the company values: Accountability, Passion, Innovation, Integrity, Urgency, Inclusion.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• RS: · Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ years’)
• OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4+ years’)

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Must be able to understand stability process, quality, and integrated validated systems, in context of multiple LIMS systems
• Experience in processing LIMS tickets, demands, and enhancements requiring successful UATs
• Experience working across departmental and functional lines.
• Must be able to work across border, cultures and multiple time zones
• Must be able to operate within a global organization that encompasses different drug product platforms, multiple operational sites, and multiple LIMS systems and platforms
• Strong understanding of GMP requirements.
• Familiarity with Data Integrity principles is a requirement.
• Familiarity with Quality Risk Management is a benefit.
• Fluency with the French language is a bonus.

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $100,000.00–$111,600.50.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards