Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
This position is responsible for LIMS operations at Emergent Manufacturing Operations-Baltimore (EMOB). This includes management of LIMs staff along with providing support for administrative functions involving the global Laboratory Information Management System (LIMS). The LIMS manager should be able to offer support to database structure, auditing functions, report query configuration, as well as facilitate and support improvements to the business processes using electronic systems.
• Provides hands-on supervision to LIMS staff to provide support to end users for new/existing LIMS applicants at Emergent
• Oversee and organize the design and implementation of new or revised methods, workflows, or processes to meet or improve the Lab operations.
• Assist users with issues, organize troubleshoot LIMS-related errors and coordinate with the IT team to assist with corrections, as needed.
• Serve as the LIMS trainer/training coordinator overseeing the training of staff prior to the implementation of the computer system and offer advice and guidance on utilization of the LIMS application, as necessary.
• Aid in the creation of SOPs or other required documentation for the system
• Duties may include other support for instruments and related software that interact with the system
• Organize and support program maintenance/modification, performance tuning, problem solving, gathering, and writing technical specifications
• Participate in team projects (local and global)
• Gather and analyze user requirements, development, testing, and implementing applications, training users, as well as documenting the implementation process
• Work closely with Quality Control, Quality Assurance, IT, CSV, and other functional business units and users to generate user requirements and understand system functionality and use, as well as assist in implementation of new functionality
• Design of new functionality and overall system improvements
• Primary responsibility is to perform administrative activities for the SampleManager® LIMS software and LABvantage. Including (but not limited to):
• User account information
• System configuration
• Change Request administration
• Report generation
• Data export
• Database management/validation
• System troubleshooting
• Assist with sample delivery/receipt within the Quality Control Labs, as necessary
• Assist with the validation of system improvements (drafting user requirements, PQ protocols, and execution of protocols).
• Author and collaborate on SOPs, Deviations, CAPAs, and Change Controls as necessary
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor's degree in Biology, Biochemistry, Chemistry, Computer Science, Software Engineering, or similar area of study from an accredited college or university or commensurate work experience in applicable fields.
• 5-8 years of experience within a cGMP/FDA/Biotechnological/Pharmaceutical environment. Previous management or leadership experience preferred.
• Consideration will be given to candidates with a combination of education/training and relevant work experience with skills in computer/LIMS system and 21 CFR Part 11 compliance in a GMP/GLP regulated industry.
• Experience working in or administering a LIMS application for a lab in the biological sciences, and strong knowledge on Empower
• Strong written and oral communication skills
• High level of motivation and independence
• Basic skills and fluency in LIMS Systems, Adobe, Microsoft Word, Outlook, and Excel
• Strong analytical, troubleshooting, and problem-solving abilities
• Ability to work independently and in teams
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.