At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
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**Job Function: **
Quality
**Job Sub Function: **
Quality Control
Job Category:
Professional
All Job Posting Locations:
Wilson, North Carolina, United States of America
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are currently seeking a highly qualified individual to join our team as a Technical Expert, Raw Material Testing & Release Quality Control reporting to the Senior Manager of Quality Control at our new Large Molecule Drug Substance Manufacturing facility in Wilson, North Carolina. In this key role, you will provide technical ownership for raw material and excipient testing within the Quality Control laboratory, including method lifecycle management, laboratory investigations, and support of computerized systems used to generate, review, and maintain compliant raw material data. This role does have the potential to grow into a people leadership position.
A pre-identified candidate for consideration has been identified. However, all applications will be considered.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
Key Responsibilities:
- Serve as the QC technical subject matter expert (SME) for raw material testing supporting large molecule drug substance manufacturing, including establishment and lifecycle management of raw material specifications, test methods, and control strategies.
- Lead laboratory testing and release of raw materials and excipients (e.g., buffers, salts, media components, resins, filters, single-use components) using compendial and non-compendial methods, ensuring adherence to cGMP, data integrity, and ALCOA+ expectations, as well as, method optimization/process improvement, compendial signals compliance, support supplier qualification and reduced testing activities.
- Own method lifecycle activities for raw material testing, including method selection, verification/validation, transfers, robustness assessments, reference standard management, and troubleshooting of atypical results.
- Lead complex laboratory investigations (OOS/OOT, deviations, atypical results) for raw material testing; perform root cause analysis, define CAPA, and ensure timely, scientifically sound documentation.
Qualifications:
Education
- Bachelor’s Degree in Science or Engineering related field is required.
Experience and skills
Required
- A minimum of 4 years of related work experience in a biopharmaceutical or pharmaceutical Quality Control laboratory, with direct experience testing raw materials and/or excipients supporting biologics manufacturing.
- Strong working knowledge of cGMP and global regulatory expectations (e.g., FDA, EU, ICH) as applied to raw material control, compendial testing (USP/EP/JP), data integrity, and regulatory inspection readiness.
- Demonstrated experience with QC laboratory systems and documentation workflows (e.g., LIMS, chromatography data systems, electronic notebooks), including compliant data review and traceability.
- Hands-on technical expertise with analytical techniques commonly used for raw material testing, such as HPLC/UPLC, UV-Vis, FTIR/Raman, titration, pH/conductivity, TOC, endotoxin/bioburden, and particulate/visual inspection as applicable.
- Ability to independently troubleshoot analytical methods and laboratory equipment issues impacting raw material testing, and to partner effectively with Manufacturing, QA, MSAT, Supply Chain, and external suppliers.
Preferred
- Experience establishing or revising raw material specifications, supplier qualification/testing strategies, and risk-based control approaches aligned with process needs and regulatory expectations.
- Experience leading or authoring investigation records (OOS/OOT, deviations), technical reports, and validation/verification protocols and summaries for raw material methods.
- Knowledge of computerized system validation (CSV) and instrument qualification practices for QC systems supporting raw material testing (e.g., LIMS, CDS), including change control and periodic review.
- Demonstrated ability to drive continuous improvement in raw material testing (e.g., method modernization, cycle time reduction, right-first-time documentation, automation/digital enablement).
- Strong technical writing and communication skills, with the ability to translate complex analytical and quality concepts to diverse stakeholders and defend decisions during audits and inspections.
- Proven ability to manage multiple priorities in a dynamic manufacturing environment while maintaining scientific rigor, compliance, and a strong quality culture.
Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.
If you are passionate about quality in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a Technical Expert Analytical Instrument and Lab Systems. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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**Required Skills: **
Preferred Skills: