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 https://www.jnj.com

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Business Enablement/Support

All Job Posting Locations:

Raritan, New Jersey, 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 searching for the best talent for a Lentiviral Change Control Specialist to join our Team! This is an onsite/hybrid role.

Major Responsibilities:

As a Lentiviral Vector Manufacturing Change Control and Document Specialist, you will:

• Support process changes arising from updates to equipment, materials, excipients or finished goods requirements

• Support efforts to establish and streamline the site change control process

• Act as change control champion for operations by owning the change control from Initiation through completion

• Participate in global forums/team meetings for Change control

• Run reports and conduct data analysis to support establishment and monitoring of change control for operations.

• Be responsible for authoring, reviewing and approving relevant LV manufacturing and equipment documents, MBR’s, SOP’s, FRM’s, TMD’s and WI’s

• Be responsible for analyzing and updating controlled documents for inconsistencies, gaps or errors to drive process quality improvement

• Lead cross functional team meetings to prioritize updates to MBRs/ EBR/MES updates.

• Lead implementation of corrections / CPAs by working with SMEs, Correction/ CPA owners, and tech writers to maintain timelines.

• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements

Qualifications:

• An Associate’s degree with at least four (4) years of related experience OR a Bachelor’s degree with at least two (2) years of related experience is required.

• Ability to read, analyze, and interpret procedure manuals, common scientific / technical journals, basic financial reports and legal documents, general business periodicals, and government regulations

• Excellent written and oral communication skills to respond to critical inquiries or complaints from top managers, regulatory agencies, or members of the business community

• Experience with internal and/or external regulatory audits

• Experience with quality investigations, including root-cause analysis of Non conformance events

• Demonstrated ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations

• Experience within Cell/Gene therapy, Biopharmaceutical, or Pharmaceutical industry

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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Agile Manufacturing, Analytics Dashboards, Chemistry, Manufacturing, and Control (CMC), Communication, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Issue Escalation, Operational Excellence, Pharmaceutical Industry, Plant Operations, Proactive Behavior, Problem Solving, Process Optimization, Project Administration, Quality Auditing

 

 

The anticipated base pay range for this position is :

$63,000.00 - $101,430.00

Additional Description for Pay Transparency:

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits