QC Instrument Specialist

Job Description

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

The Wilmington Biotech Campus will play a pivotal role in the manufacture of our companys biologics-based medicines including the areas 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 (ADCs) and High Potent Compounds and will also be critical in the future supply of new biotechnology products to its global network.

Wilmington Biotech Campus Quality Control Laboratory

The Quality Control (QC) Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our companys pipeline of high potent Biologics. 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 under our Manufacturing Division with close collaboration with our Research & Development Division.

Reporting to the QC lead for Instrumentation & Digital Systems the Quality Control Instrument Specialist will support the start-up and ongoing operation of new laboratory facilities by assisting with the procurement commissioning qualification and lifecycle management of analytical instrumentation. This role ensures that laboratory instruments are maintained in a validated and calibrated state to support analytical testing in compliance with regulatory and quality standards.

Key Accountabilities:

New Facility & Laboratory Start-Up:

• Support the procurement and installation of laboratory instrumentation including coordination with vendors and internal stakeholders

• Assist with the development and execution of instrument commissioning and qualification (IQ/OQ/PQ) protocols

• Prepare and review supporting documentation for instrument qualification activities to ensure the highest standards of execution including SOPs maintenance plans equipment classifications and qualification documentation

• Coordinate with Quality Assurance (QA) Information Technology (IT) and Global Engineering Services (GES) functions to ensure commissioning and qualification activities are completed on schedule to support operational readiness

• Support interaction with qualification services providers and external laboratory support groups

Post Go-Live Instrument Lifecycle Management:

• Execute maintenance and calibration activities in accordance with established schedules and regulatory expectations

• Ensure all laboratory instrumentation is maintained in a fully validated and calibrated state in support of analytical testing

• Support the instrument management quality system including documentation of instrument status deviations and change controls

• Assist with troubleshooting instrument issues and coordinating repairs with vendors

• Maintain inspection readiness of all laboratory instruments and systems at all times

Quality & Compliance:

• Support the development and maintenance of instrument-related SOPs work instructions and quality system documentation in compliance with cGMP biosafety corporate policies and regulatory requirements

• Ensure compliance with Data Integrity and Good Documentation Practices requirements related to laboratory instrumentation

• Support and/or lead equipment troubleshooting and related deviations CAPAs and change controls

• Participate in internal audits and support health authority inspections as needed

Collaboration & Development:

• Liaise with cross-functional teams including our research division IT Quality Assurance and Engineering

• Support training activities for laboratory personnel on instrument operation and maintenance

• Contribute to continuous improvement initiatives for instrumentation processes

Qualifications / experience

Education

• Bachelors degree in Chemistry Biochemistry Engineering or a related scientific discipline.

Experience

• Minimum 2 years of industry experience in a regulated laboratory environment (pharmaceutical biotech or related industry)

• Experience with analytical instrumentation commonly used in QC laboratories (e.g. HPLC/UPLC plate readers mass spectrometers analytical balances etc.)

• Familiarity with instrument qualification (IQ/OQ/PQ) and calibration principles

• Exposure to GMP environments and quality management systems is required

• Experience with core laboratory & quality systems including Empower Softmax Pro GLIMS LabX MODA Biovia SAP Veeva etc.

Core competencies and skills

• Strong attention to detail and documentation practices

• Strong critical thinking skills and troubleshooting capabilities

• Good organizational and time management skills

• Ability to work collaboratively in a team environment

• Basic understanding of Data Integrity principles

• Familiarity with laboratory IT systems and electronic data management

• Effective written and verbal communication skills

Additional Info:

• Location: Wilmington Delaware (On-Site)

• Travel: Ability to travel 10% of the time

Required Skills:

Preferred Skills:

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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.

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