Quality Laboratory Systems Specialist

Job Description

Join our company and shape the future of healthcare in Delaware.

At our Wilmington Biotech Campus we are committed to keeping the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

Our Company: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world and today we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe sustainable and healthy future for all people and communities.

With almost 70000 employees operating in more than 120 countries you will be joining one of the worlds largest pharmaceutical companies.

Wilmington Biotech Campus

The latest addition to the companys network is the Wilmington Biotech Campus. The site will play a pivotal role in the manufacture of our companys biologics-based medicines including in the area of immuno-oncology. This site will establish our companys internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029.

This facility will be a significant supplier of Antibody Drug Conjugates and High Potent Compounds and will also be critical in the future supply of new biotechnology products to its global network.

Wilmington Biotech Campus - Analytical Development and Quality Control Laboratory

The Analytical Development and Quality Control Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of the companys pipeline

of high potent Biologics including our companys deep pipeline of Antibody Drug Conjugates. This laboratory will bring together late-stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle. The laboratory will be supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory in support of a new approach to analytical commercialization for high potent Biologics. The laboratory will be operated in collaboration by our Research Laboratories and our Manufacturing.

Laboratory Systems Specialist:

Job Purpose:

• Reporting to the Wilmington Laboratory Lead the Laboratory System Specialist will support the development of the Laboratory Quality Management System (QMS) for the Wilmington laboratory.

• This will involve the use of the companys Research Laboratories Clinical Supplies QMS and the our companys Manufacturing Division Commercial QMS to develop a local QMS in support of the scope of analytical work to be completed at the Wilmington laboratory.

• Post laboratory start up the role will support ongoing maintenance and change control for the Wilmington laboratory QMS.

Principal Accountabilities:

• Support the development of a Laboratory QMS to bring together the research divisions Clinical Supplies and the manufacturing divisions Commercial QMSs into a single laboratory QMS;

• Identify the full scope of work of the laboratory

• Understand the regulatory compliance guidelines that will be applicable (ie FDA. EMA PMDA etc)

• Work with site Quality and Global QMS Topic leads to define a strategy for QMS development for the Wilmington laboratory.

• Develop approaches to maximize the use of global SOPs at the Wilmington lab.

• When needed map key local processes to support local SOP development.

• Support development of SOPs for Analytical Instrumentation operations and administration.

• Support development of SOPs for Outsourced Testing and Services.

• Ensure appropriate technical safety and quality review and approval of SOPs takes place prior to deployment.

• Ensure that appropriate change control and training programs are in place for the laboratory QMS.

• Post laboratory start up support the ongoing maintenance and change control for the laboratory QMS.

Required Education:

• BS degree in science biology chemistry or some similar

Required Experience and Skills:

• 2 years of industry experience working directly in the field of analytical test instrumentation and/or tech transfer.

• Preferably will have a strong Quality background.

• Experience with a number of the following key levers:

• Experience with laboratory instrument Commission and Qualification Data Integrity and Quality Systems.

• Experience with SOP creation and update.

• Good knowledge of global compliance requirements.

• Demonstrated examples of driving change in a positive way.

Additional Info:

• Location; US Delaware Wilmington (On site role)

• The successful individual will need to be available on site at the Wilmington Biotech site

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

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U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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