Technical Expert, Raw Material Testing & Release Quality Control

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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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 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 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 strongportfolio growth and continue delivering breakthrough innovation and transformational medicinesfor patients. The new facility will expand production of innovative biologic medicines in areas including oncology immunology and neuroscience. J&Js 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

• Bachelors 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 () or contact AskGS to be directed to your accommodation resource.

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