Batch Release Senior Specialist - Johnson and Johnson

Johnson & Johnson Innovative Medicine is recruiting for a Batch Release Senior Specialist! within the External Quality, Advanced Therapies organization, to be located in the United States. This position can be located in the New Jersey or Pennsylvania area. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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/.

In this position you will lead quality oversight of the batch record review and release process for products manufactured by external manufacturers, compliant to cGMP and regulatory requirements.

Key Responsibilities:

• Maintain oversight for status of individual batches, including deviations, and target release timelines; communicate status accurately and succinctly.

• Ensure batch documentation provided by EM site is compliant with cGMPs, Company standards, chain of identity and chain of custody as well as product specifications. Ensure all required testing and documentation is provided and meets release requirements.

• Perform batch release in accordance with Company procedures.

• Provide cGMP compliance support by investigating and resolving quality issues.

• Support EM site during regulatory inspections.

• Author, revise, review and approve Quality System documents (SOP, WI etc.)

• Apply cGMP regulations and other FDA and international requirements to all aspects of the position.

• Monitor trends, identify risk, troubleshoot, escalate to senior management as necessary.

• Interface with other functions (Operations, Planning, Technical Operations, Medical Affairs, Vein to Vein etc) in the support of supply chain to meet patient supply requirements.

• Assess current quality systems and recommend improvements to enhance quality and cycle time. Education:

• Bachelor's Degree in engineering, science, or an equivalent technical discipline

Experience and Skills:

Required:

• A minimum of six (6) years working in an FDA regulated environment
• Experience with quality support of commercial manufacturing operations
• Experience managing quality oversight for pharmaceutical products
• Proven experience working with external partners
• Experience with batch record review and release processes
• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production
• Proven experience leading teams to achieve a common goal
• Strong interpersonal and written/oral communication skills with the ability to establish relationships.
• Ability to quickly process complex information and make critical decisions with limited information
• Proficient in applying process excellence tools and methodologies

Preferred:

• Other Advanced degree
• Experience with cell therapy batch release process

Other:

• English

• The anticipated base pay range for this position is $91,000- 147,200 USD$

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)).
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 Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.]