USDM Life Sciences Overview
USDM Life Sciences provides a variety of IT and compliance solutions to help life sciences companies streamline laboratory, clinical, and manufacturing operations while staying in compliance with FDA regulations. USDM disrupts convention and delivers compliance with proficiency, simplicity, and efficiency to achieve better results for our customers that are in the business of saving lives. It's a place where you can make an impact in the world as a champion for life sciences innovation and also get the experience and mentoring to grow your career.
Founded in Santa Barbara, California in 1999 by two UCSB graduates, USDM has grown to a global company with offices throughout the US, Toronto, Canada, and Frankfurt, Germany.
Nature and Scope of Job
Partners with Lab owners to plan and implement new lab instrument/system implementations in compliance with the appropriate regulatory standards (GxP/21 CFR Part 11) and follow best practices within the pharmaceutical/biotech industry. Collaborates closely with Lab owners and IT Compliance (when required) to implement Lab systems and applications in accordance with SOPs, as well as work with the Lab owners to create roadmaps for all existing systems. This job contributes to and supports the company's research and development efforts to create high-value therapeutics to address unmet medical needs. Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
Proactively applies professional concepts to contribute to the development of the company's concepts and principles and to achieve objectives in a creative and effective way.
Provides guidance on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
Coordinate planning, scheduling, and implementation of Lab systems and instruments with Lab owners, as well as facilities personnel, and other IT internal resources (IT Compliance and Infrastructure Groups) as required and in compliance with relevant policies, guidelines, and procedures.
Works with Business System Owner and IT System Owner for all Lab Applications such as Empower, Agilent NuGenesis, Dotmatics, and other similarly classified applications, coordinating downtimes for project-related upgrades, updates, and configurations.
Provide technical expertise for the support of existing systems, escalating and coordinating resolution with the vendor when required.
Implementation of the computer requirements in conjunction with lab system vendors when those computer requirements are limited to a networked PC.
Assist with solutions identification, evaluation, selection, implementation, testing, and working with the IT technical delivery team(s) to meet and exceed business requirements.
Assist the systems validation process executing test scripts as required
Lead PC system configuration and assist with server-based system configuration and general IT duties as needed.
Assist in Lab Expansion projects; work with designated teams during Regulatory Audits and Inspections.
Analyze the business implications of the application of technology to the current business environment.
Initiate lab systems analysis, validation testing, training, and implementation of new or enhanced lab system functionality, including analyzing and designing complex lab systems.
Initiates and drives the implementation of lab systems with comprehensive consideration of user requirements, systems integration, and project timelines; and ensures that the Company is equipped with systems that are reliable and compliant.
Play a key role in working with system user groups, and system support groups to maintain a high level of communication and collaboration.
Ensure system requirements include quality and compliance considerations.
Analyze lab system needs, documents requirements, and revises existing systems.
Develop a variety of test plans.
Leverage in place project management system to assist in measuring, managing, and planning lab system initiatives.
Ensures cGMP and compliance requirements are met and/or exceeded on designated activities.
Works on and may lead other projects as assigned.
A minimum of a Bachelors' degree in Computer Science, Information Systems, or related discipline is required. Equivalent experience may be accepted.
A minimum of 8 years of industry work experience is required with 5 years of practical work experience as a Lab Specialist with experience in a life sciences/healthcare organization.
Strong core IT fundamentals background with a focus in PC / lab instrument integration accompanied with knowledge of R&D as well as GxP laboratory information systems.
Familiarity or experience with laboratory data management platforms such as ELN and results & analysis platforms such as LIMS
A knowledge of Laboratory Systems requirements and configuration definition.· An ability to support critical Lab Applications such as Waters-Empower, NuGenesis, Dotmatics, etc..
Knowledge of validation lifecycle of lab GxP computerized systems.
Strong analytical skills to identify and resolve problems and the ability to effectively apply a broad range of professional concepts, practices, and methods in moderately complex and diverse circumstances are required.
The ability to effectively assess end-user issues, demonstrating the ability to resolve and integrate solutions.
The ability to understand and evaluate organization-wide impacts of application changes.
The ability to lead projects from implementation to long-term maintenance.
A working knowledge of 21 CFR Part 11, 68, 210, 211, USP 1058; Computer Systems Validation and GAMP framework.
A knowledge of GMP/GLP Lab and instrumentation support background and experience required.
Experience working in a Research or GxP lab along with common chemical and biological hazards.
Experience with drug discovery, translational medicine, and the IND/NDA process.
Experience in the validation of Computer Systems and GAMP5 Methodology, CFPIE, and the Change Control Process in the Life Sciences industry.
Experience with electronic ticketings and document management systems such as FootPrints, ServiceNow, MasterControl EDMS, and EQMS, and Veeva QMS.
Experience with client/server architecture, general networking concepts, office, and desktop applications: Access, Word, Excel, PowerPoint, Outlook SmartSheets, etc.
Experience working in a GMP pharmaceutical manufacturing environment or other regulated environment is highly preferred.
Excellent communication skills with the ability to present ideas in a clear succinct manner, both verbally and in writing are required. Must be able to work independently and efficiently on several tasks at once
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Travel to client site for onsite work as needed.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.