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Laboratory Electronic Systems Analyst

Employer
Coherus BioSciences
Location
Camarillo, California
Start date
Nov 12, 2022

View more

Discipline
Science/R&D, Research, Laboratory
Required Education
Associate Degree
Position Type
Full time
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Job Details

Title:                            Laboratory Electronic Systems Analyst
Reports To:                
Vice President, Analytical Sciences
Location:                     Camarillo, CA
Classification:            Non-Exempt
 

Overview:

We are seeking a highly motivated individual to join the Coherus Team as Electronic Laboratory Systems (ELS) Analyst. This newly created role will report directly to the VP of Quality Laboratories and will be responsible for the configuration, implementation, administration, and maintenance of the laboratory electronic systems in a GxP environment. In this hands-on role, the incumbent will actively manage laboratory electronic systems including the Laboratory Information Management Systems (LIMS), Electronic Notebook (ELN) and/or Laboratory Execution System (LES), Chromatography Data System (CDS) and other laboratory applications following GxP regulations. The ELS Analyst will work closely with stakeholders to identify and implement electronic solutions that support laboratory workflows including training and providing guidance of the lab staff. The ELS Analyst will further configure and maintain functionality within laboratory software systems as appropriate. Adhering to Coherus’ change management procedures, the Analyst will work closely with internal IT, QA, and external 3rd parties to maintain current software versions and coordinate upgrades.

Responsibilities:

  • Implementation and configuration of LIMS, ELN, LES, CDS, and other laboratory applications compliant with GxP and applicable internal IT procedures.
  • Provide operations support to end users in the use of laboratory electronic systems while meeting GxP compliance requirements.
  • Work closely with laboratory personnel, vendors, QA, and other IT professionals to assure systems are configured and maintained in a manner that addresses business needs, compliance to GxPs, and maximizes the system's efficiency and performance.
  • Monitor performance health of the laboratory electronic systems and coordinates with vendors for any requirements for system maintenance.
  • Supports IT GxP team and vendors in creation and execution of computer system validation documents (i.e. UAT, URS, OQ, PQ, etc.).
  • Assist in the creation and maintenance of related SOPs.
  • Serve as technical point of contact for troubleshooting, addition of new instruments and/or workflows into the laboratory as well adding new end users.
  • Work closely with the laboratory leadership and project management teams to ensure the successful execution of projects
  • Ensure laboratory data are available, secure, and maintained in accordance with regulatory requirements.
  • Establish procedures that effectively secure the laboratory electronic systems and related applications and actively mitigates potential security risks.
  • Partner with IT Infrastructure team and external vendor to ensure the data and applications are protected according to the company’s disaster recovery policies.
  • Be onsite to install upgrades, new instruments/workflows, troubleshoot issues, and perform upgrades as needed.
  • Other Duties & Responsibilities as assigned

Qualifications:

  • Experience in working with regulated (e.g., validated, 21CFR part 11 compliant), computerized systems.
  • Hands-on experience configuring and maintaining commercial GxP laboratory electronic platforms.
  • Working knowledge of GxP regulations as system administrator of laboratory electronic systems
  • Working knowledge in laboratory system testing, qualification, validation, problem resolution, and training preferred.
  • Background in laboratory computing environment including instrument and system interfaces and familiarity with laboratory procedures preferred. Alternatively, experience in any regulated environment, such as healthcare, will be considered.
  • Experience with Thermo Sample Manager software preferred.
  • Ability to explain technical details to non-technical colleagues
  • Strong written and verbal communication skills across different and diverse groups or individuals
  • Ability to establish and maintain effective working relationships across the organization
  • Ability to work under pressure and troubleshoot problems in real time
  • Excellent analytical and problem-solving skills
  • Participate and support internal and agencies audits

Education and Experience:

  • Bachelor’s Degree in Computer Science, health-care related degree, or other technical degree with required experience.
  • Minimum 4 years’ experience with regulated electronic systems and software, ideally in a laboratory setting.

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. 

Company

Coherus is focused on expanding patient access to important, cost-effective medicines and delivering significant savings to the U.S. healthcare system. Every member of the Coherus team is dedicated, motivated, and passionate about expanding patient access to lifesaving therapeutics. Our colleagues are experts in analytical and process sciences, deeply experienced in clinical development and regulatory affairs, and have proven commercial and marketing capabilities. Everyone at Coherus is committed to meeting the highest standards, inspiring our teammates, and achieving our goals.

Coherus was founded a decade ago to provide the highest quality biosimilar treatments to patients. We are proud to now be expanding our legacy—to build on our success with biosimilars and to focus our core strengths on immuno-oncology.

At Coherus, our employees are our most important asset. We have a dynamic and rewarding organizational culture that offers the opportunity to work with leading industry professionals who are dedicated to making a difference for patients. We are looking for individuals who see unlimited potential in themselves and are motivated by a continuous passion for breaking down barriers and expanding access to lifesaving therapeutics.

Coherus offers a competitive total rewards program comprised of various elements, including competitive base pay, short- and long-term incentives in the form of performance-based cash and equity, as well as health and wellness benefits that include

•    Healthcare: Coherus pays 90% of premiums for medical, dental, and vision coverage for our

     employees, their eligible spouses, dependents, and domestic partners.
•    Health Savings and Flexible Spending Accounts
•    Group Life, Disability, and Group Accident Insurance
•    401(k) with company match, and an Employee Stock Purchase Plan (ESPP)
•    Paid Time Off (PTO) 
•    Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program
 

Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program

In addition to providing attractive rewards packages, we encourage and support our employees to find the right balance of work and personal time. Coherus offers a variety of activities, perks, and holidays that encourage employees to have a healthy outlook, spend time outside of work with friends and family, and foster a productive and collaborative work environment. Our culture is one in which we challenge and support all our team members to do their best work.

For more information about Coherus, please check out: https://www.coherus.com/about-coherus/

Find Us
Website
Mini-site
Coherus BioSciences
Phone
800-794-5434
Location
333 Twin Dolphin Dr, #600
Redwood City
CA
94065
US
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