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.
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.
**Job Function: **
Quality
**Job Sub Function: **
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Wilson, North Carolina, United States of America
Job Description:
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 currentlyseeking a highly qualified individual to join our team as a QC Microbiology Team Lead at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC). In this key people-leadership role, you will be responsible for day-to-day supervision, coaching, and technical oversight of a team of QC Microbiology Analysts performing microbiological testing of raw material, in-process, and final product samples submitted to the QC laboratories. You will ensure work is executed in compliance with all applicable procedures, standards, data integrity expectations, and GMP regulations, while driving continuous improvement and a strong quality and safety culture.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth to 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 and our future innovations.
Essential Job Duties and Responsibilities:
Provides direct day-to-day leadership for the QC Microbiology team, including work planning, task assignment, shift/coverage coordination, and escalation management to meet testing turnaround times and production schedules.
Provides technical oversight for execution of microbiological testing (e.g., bioburden, endotoxin, growth promotion, microbial identification, environmental monitoring and utilities-related microbiology, as applicable) and ensures adherence to methods, aseptic technique, and laboratory controls.
Leads and/or performs review and approval of laboratory data (peer review and second-person verification), ensuring completeness, accuracy, and compliance with data integrity expectations.
Owns, authors, and reviews SOPs, work instructions, and technical documents for the QC Microbiology laboratory; ensures controlled documents remain current and fit-for-purpose.
Delivers onboarding, training, and routine coaching for QC Microbiology personnel; ensures analyst qualification, method proficiency, and compliant training completion.
Ensures consistent and compliant use of electronic systems (eLIMS, MES, electronic logbooks, etc.) for execution and documentation of testing; supports troubleshooting and user adoption.
Promotes and maintains a safe work environment and strong GMP culture; ensures team compliance with environmental, health, and safety requirements and promptly addresses safety concerns.
Collaborates with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QA, etc.) to investigate, troubleshoot, and resolve quality events, excursions, and atypical results; supports deviation investigations, CAPAs, and change controls related to microbiology testing.
Leads or co-leads functional laboratory meetings (tier huddles, daily management, shift handoffs) and drives clear communication of priorities, risks, and actions.
Coaches and reinforces Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) expectations within the QC Microbiology laboratory; identifies and addresses gaps in compliance.
Ensures team’s capability to read, interpret, and execute SOPs, work instructions, test methods, and protocols; provides clarification and technical direction as needed.
Proficient with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and able to generate clear metrics, dashboards, and written summaries for stakeholders.
Owns routine data trending, statistical analysis, and reporting for microbiology programs (as applicable); identifies signals, escalates risks, and drives appropriate investigations and improvements.
Ensures the team maintains training and qualification completion in a compliant state; reviews training effectiveness and supports audit readiness for the laboratory.
Approves quality records.
Qualifications:
- Bachelor's degree in Microbiology, Biology, Biochemistry, or related field is required (advanced degree preferred).
- Minimum six years experience working within the biological and/or pharmaceutical industry in a microbiology laboratory setting is required.
- Knowledge of compendial (USP, EP, JP, etc.) requirements and standards for QC testing
- Prior demonstrated success as a people leader.
- Understanding and experience in application of global regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment.
- Experience with Quality Control document authoring and reviewing.
- Experience with regulatory inspections
Other Requirements:
- An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
- Proven ability to manage multiple priorities and work independently with minimal supervision.
- Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
- Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
- The ability to work in a team environment and interact with all levels of the organization.
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 QC Microbiology Team Lead. 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: