Senior Manager, Global Process Development, Fill-Finish Operations

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:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

People Leader

All Job Posting Locations:

Malvern, Pennsylvania, 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 Senior Manager, Global Process Development, Fill-Finish Operations based in Malvern, PA.

Purpose:

This role involves leading our non-clinical Fill-Finish operations team responsible for supplying vial, pre-filled syringe, and pre-filled cartridges in support of the development of innovative biotherapeutics. The individual will contribute to the design and execution of experiments, advance next-generation manufacturing technologies and approaches, and improve standard procedures.

They will also be responsible for championing and deploying digital tools for operational efficiency, informed decision-making, and lean technology transfer to GMP manufacturing sites. Additional responsibilities include oversight of raw material procurement and inventories, troubleshooting manufacturing equipment, leading investigations including implementation of corrective/preventative actions, CAPEX/OPEX planning and execution, mentoring direct reports and junior team members, and upholding Johnson & Johnson’s values in a dynamic

research environment. This position offers an opportunity to grow as a developing scientist while making meaningful contributions to cutting-edge biotherapeutic manufacturing solutions.

You will be responsible for:

• You will be accountable for achieving Key Performance Indicators (KPIs), monitoring and striving to improve performance metrics related to uptime, training, investigations, CAPAs, yield, production cadence, operational availability, and more.
• You will work collaboratively with cross-functional teams to streamline process development and technology transfers, meanwhile nurturing and empowering your operations team.
• You'll get to foster a culture of continuous learning and improvement, leading or supporting various site functional and cross-functional structures for departmental alignment.
• Tackling resource constraints and needs, you will champion operational and technical excellence for efficient production and implement Lean principles for process optimization.
• You will leverage digital tools for operational efficiency and informed decision-making, keeping pace with emerging digital technologies relevant to manufacturing processes.
• You will scout and benchmark new functionalities and capabilities and connect across TDS development organizations to drive and align consolidated value creation.
• Advancing the pipeline by collaborating with multi-functional teams, including process engineers, drug delivery systems engineers, and formulation scientists.
• Contribute to strategic initiatives, mentor and upskill our workforce
• Education: Minimum of a Bachelor’s degree in Engineering, Science, Technical, or other relevant fields is required
• Advanced degree in Engineering, Science, Technical, or other relevant fields is preferred
• Required: Minimum of 8 years of relevant industry experience.
• Minimum of 4 years of demonstrated leadership ability and experience managing, coaching, and/or mentoring high-performing cross-functional teams.
• Demonstrated experience in biologics manufacturing is required, specifically drug product sterile manufacturing is preferred.
• Manufacturing leadership & operations is required, with preferred multi-product experience.
• Capable of influencing and building relationships across organizational layers, as well as externally with partners.
• Strong scientific communication and collaboration skills, with the ability to work effectively in a multidisciplinary team.
• Preferred: Experience/in-depth knowledge of regulatory filings
• 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: