Laboratory Information Specialist Job at Lundbeck
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!
SUMMARY
Lundbeck Seattle BioPharmaceuticals is looking for a Laboratory Information Specialist to join the CMC Biologics team.
In this newly created role, you will have the opportunity to make a strong impact as a key member of the implementation and support team for a new ELN (Electronic Notebook)/data management system for use within the process development organization. You will also support scientists in CMC Biologics with other laboratory IT projects and data management needs by partnering with the line of business and Global IT. The successful candidate will be an organized and customer-service focused person who enjoys interacting with process development scientists to find better ways to manage and visualize data. You will also enjoy taking a hands-on approach to administration of laboratory information systems (LIMS, including electronic notebooks).
ESSENTIAL FUNCTIONS
- Help lead implementation of a new ELN/data management system (as system administrator) in collaboration with a team of bioprocess development scientists, Lundbeck Global IT, and the vendor
- Support development and execution of data migration and system decommissioning plans for legacy systems
- System administrator for the new ELN/data management system
- Manage user accounts (permissions, access levels)
- Maintain required internal documentation (per applicable SOPS)
- Train users in collaboration with superusers from line of business
- Develop templates, custom reports, database queries and other tools needed by scientists to help them better manage and visualize their data
- Coordinate with vendor and Global IT on system upgrades, maintenance, and troubleshooting; track issues and ensure resolution
- Maintain alignment with the global IT team, including project managers, Solutions Architects, and local IT staff to ensure compliance with global IT guidelines and SOPs
- Develop strong understanding of laboratory data management needs by developing excellent working relationships and through frequent communication with scientists
- In collaboration with scientists, recommend and implement solutions for enhancing data management by optimizing how electronic systems are used
- Serve as system administrator for a validated stability LIMS; support change controls and system upgrades, maintain systems in validated states in alignment with corporate SOPs
- Support CMC laboratory staff with other laboratory IT projects (as needed) by representing the system owners (the scientists in the line of business) and serving as an interface between the systems owners, Global IT, and vendors
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited BS or MS in Computer Science, Engineering, Technology, or related scientific discipline
- Minimum of 5 years experience in a similar role
- Previous experience (2+ years) with administration of electronic systems (such as ELN, LIMS, SDMS or other related system) used in labs within a biotech or pharmaceutical company
- Solid understanding of data management, database structure and data warehouses; demonstrated experience with data flow mapping
- Excellent working knowledge of FAIR data principles
- Hands-on experience with scripting languages such as Python and ability to write SQL queries to extract information from ELN and LIM systems
- Experience with cloud computing platforms
- Demonstrated ability to interface with scientists and understand their data management needs including creation of templates, reports, queries, or visualizations
- Ability to work cross-functionally with excellent verbal communication and collaboration skills
- Strong written communication skills with ability to summarize information in a logical, organized, clear and persuasive manner
- Customer-focused mindset
- The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
- Basic understanding of license models; experience interacting with commercial vendors, maintaining system upgrades, and renewal of contracts with vendors
- Experience with implementation of new electronic systems (such as ELN, LIMS, SDMS or other related system)
- Experience with data migration from legacy database systems and system decommissioning
- Experience integrating computerized laboratory systems (such as Chromatography Data Systems) with ELNs/data management systems
- Knowledge of software development life cycle for GXP regulated industry, including 21CFR part 11 requirements and computerized system validation requirements
The range displayed is specifically for those potential hires who will work or reside in the state of California / Washington, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $135,000 - $165,000 and eligibility for a 15% bonus target based on company and individual performance. Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and company match 401k.
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Why Lundbeck
Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time?
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the
U.S. career site
.
Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in
E-Verify
.
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