Lentivirus Batch Record Coordinator
J&J Family of Companies
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:**
Professional
**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** **Lentivirus Batch Record Coordinator to be in Raritan, NJ.**
**Purpose:** Contributes as an entry to developing individual contributor, who works under close supervision. Helps implement projects, programs, and processes in support of the organization's overall Manufacturing Pharmaceutical Process Operations strategy. Applies theoretical knowledge of the Manufacturing Pharmaceutical Process Operations field to carry out procedures and plans for the area.
**You will be responsible for:**
+ Be part of the manufacturing operations team responsible for production of Lentiviral vectors for the autologous CAR-T products in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
+ Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.
+ Communicate accurate and up-to-date status reviews to appropriate personnel and update status on tracking spreadsheets and prepare reports.
+ Assist in the correction of deficiencies found within the documentation reviewed per the cGMPs and SOPs on daily basis
+ Ensure documents like batch records, labels, forms, etc. are printed and available for production
+ Oversee batch records review and completeness of all associated documentation ensuring compliance with written Policies and procedures as required for batch release
+ Perform First review for executed batch records daily
+ Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
+ Perform other assigned duties as may be required in meeting company objectives
+ Perform tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.
+ Aid in the development of manufacturing processes including appropriate documentation updates for master batch records.
+ Drive continuous improvement of manufacturing operations leveraging own observation as well as input of team members.
+ Be trained on the manufacturing process to support up to 20% of time processing, as needed.
**Qualifications / Requirements:**
• A High School diploma OR an Associate’s degree with at least two (4) years of related experience OR a Bachelor’s degree with at least two (2) years of related experience is required.
• Experience in manufacturing, maintenance, quality, testing, or engineering areas is required.
• Experience in the Pharmaceuticals or Biopharmaceuticals industry is preferred.
• Knowledge of current Good Manufacturing Practices (cGMP) is required.
• Experience in an aseptic and manufacturing environment is preferred.
• Proficiency in English (verbal and written), as well as, good communication skills are required.
• Ability to lift a minimum of 25 lbs. and to stand for a long period of time are required.
• Basic proficiency with Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required.
• This role requires being 100% on-site Monday through Friday during a normal work week. No remote work is available for this role.
• Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required.
• This position will be based in Raritan, NJ.
_Additional Information:_
The anticipated base pay range for this position is $59,000 to $74,000.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. ·
+ Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
+ Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
+ This position is eligible to participate in the Company’s long-term incentive program.
+ Employees are eligible for the following time off benefits:
+ Vacation – up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
+ Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
+ Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
**The anticipated base pay range for this position is :**
The anticipated base pay range for this position is $59,000 to $74,000.
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. · • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • This position is eligible to participate in the Company’s long-term incentive program. • Employees are eligible for the following time off benefits: ○ Vacation – up to 120 hours per calendar year ○ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year ○ Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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