Laboratory Informatics Process Owner
Apply NowCompany: KBI Biopharma, Inc.
Location: Boulder, CO 80302
Description:
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.
Position Summary:
The Laboratory Informatics Process Owner is responsible for driving implementation of KBI Laboratory Information Management (LIMs) system(s) to improve the efficiency and compliance of business processes. This matrix leadership role bridges together our company's laboratory processes, IT software management, software providers, and other global groups involved in Digital Transformation as a user representative. Responsibilities will involve interacting with global and local IT support functions to manage product feature enhancements and workflow implementations. The role will facilitate monitoring, execution, maintenance, and continuous improvement of Laboratory IT Systems for labs with an emphasis on continuous improvement. This role will serve as a user representative for laboratory IT systems and will be responsible for mentoring and educating peers on the use of lab systems, supporting audits, and oversight for management reviews, laboratory metrics, and laboratory documentation.
Responsibilities:
Requirements:
Minimum requirement is a bachelor's degree in Life Science, Computer Science, Engineering, or related field with a minimum of 5 years of experience in biotechnology or biopharmaceuticals. Additionally, 2 years' experience with project management either leading the project or leading a workstream.
The Laboratory Informatics Process Owner will work with users and IT representatives to implement new processes and systems and improve existing ones, meet developing business needs and driving efficiency while conforming to regulatory requirements for data integrity and security.
Experience with the following tools or concepts considered a strong plus:
Salary Range: Compensation Range: $112,320 - $154,440
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
About KBI:
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.
KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
Position Summary:
The Laboratory Informatics Process Owner is responsible for driving implementation of KBI Laboratory Information Management (LIMs) system(s) to improve the efficiency and compliance of business processes. This matrix leadership role bridges together our company's laboratory processes, IT software management, software providers, and other global groups involved in Digital Transformation as a user representative. Responsibilities will involve interacting with global and local IT support functions to manage product feature enhancements and workflow implementations. The role will facilitate monitoring, execution, maintenance, and continuous improvement of Laboratory IT Systems for labs with an emphasis on continuous improvement. This role will serve as a user representative for laboratory IT systems and will be responsible for mentoring and educating peers on the use of lab systems, supporting audits, and oversight for management reviews, laboratory metrics, and laboratory documentation.
Responsibilities:
- Work with site leadership to compliantly maintain LIMs at each site in accordance with the agreed upon project schedule and milestones.
- Work with Executive Sponsor (ES) and leaders across the organization to understand Laboratory Information Management, its business value and how to realize that business value. Translate that vision into product roadmaps in agreement with the business and align with technology strategy.
- Work with Subject Matter Experts to harmonize business processes and standardize analytical procedures as required to implement a global configuration of the laboratory systems.
- Work with Subject Matter Experts and the software vendor to translate global KBI workflows into developable software configurations (define user requirements).
- Liaison with technology to develop plans for rollouts, supporting roadmap and business objectives
- Point of contact for software vendor to identify features, bugs, and enhancements required for business workflow changes
- Build, prioritize and maintain a backlog of product features/improvements. Ensure constant clarity in terms of what is to be executed next by software configuration/validation team(s).
- Provide leadership and direction to all project support personnel - PM, business leads, consultant personnel
- Lead steering committee meetings, develop agenda, updates in conjunction with project team [Insert up to 10 bullet points that outline the responsibilities of the role. It's recommended to list the most important responsibilities first and be concise - sharing necessary information or context without being excessive or listing every duty. Focus on what the candidate will be doing on a daily or weekly basis.]
Requirements:
Minimum requirement is a bachelor's degree in Life Science, Computer Science, Engineering, or related field with a minimum of 5 years of experience in biotechnology or biopharmaceuticals. Additionally, 2 years' experience with project management either leading the project or leading a workstream.
The Laboratory Informatics Process Owner will work with users and IT representatives to implement new processes and systems and improve existing ones, meet developing business needs and driving efficiency while conforming to regulatory requirements for data integrity and security.
- Experience with LabVantage LIMS
- Solid understanding of scientific processes related to biopharmaceutical analytical development and testing.
- Basic understanding of system administration, permissions strategy, or computer system validation
- Skills in gathering requirements through interviews, business process descriptions, use cases, scenarios, and workflow analysis
- Ability to map business process with software such as Visio
- Understanding of User Experience (UX) methodology and surveys
- Ability to interpret survey results into business processes and requirements.
- Customer focus with emotional intelligence to collaborate with users to gather requirements
- A passion for technology and an appreciation for the incredible work our scientists do
- Microsoft office tools
Experience with the following tools or concepts considered a strong plus:
- Experience with ELN (IDBS), CDS (Empower), SharePoint, and/or Power BI
- Information Technology Infrastructure Library (ITTL) to understand the support strategy and implementation
- Experience with enterprise software packages used within the laboratory areas
- Use of JIRA and Confluence applications
- Certification as a business analyst
- Collaborates with global services partners and employees to co-develop roadmaps and drive products and features from concept to launch in a fast-paced environment.
Salary Range: Compensation Range: $112,320 - $154,440
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
About KBI:
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.
KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.