Senior Manager, Global Process Development, Fill-Finish Operations

Johnson & Johnson Co.; Malvern (Chester County); Vor Ort; USD 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

Equal opportunity employer

Accommodation support

Zusammenfassung

Johnson & Johnson in Malvern, PA, seeks a Senior Manager, Global Process Development, Fill-Finish Operations to lead non-clinical Fill-Finish operations for vial, pre-filled syringe, and cartridge development.

You will design and execute experiments, advance manufacturing tech, improve procedures, and deploy digital tools for efficiency and lean tech transfer to GMP sites. Mentoring is a key part of the role.

Qualifikationen

• Bachelor's degree in Engineering, Science, or related field.
• Advanced degree preferred.
• Minimum 8 years of industry experience.
• Minimum 4 years of leadership experience.
• Experience in biologics manufacturing, preferably sterile drug product.
• Ability to influence across organizational layers.
• Strong scientific communication and collaboration.

Aufgaben

• Accountable for achieving KPIs related to uptime, training, investigations, CAPAs, yield, and production cadence.
• Collaborate with cross-functional teams to streamline process development and technology transfers.
• Foster a culture of continuous learning and improvement across site structures.
• Lead Lean initiatives for process optimization and efficiency.
• Leverage digital tools for operational efficiency and informed decision-making.
• Scout and benchmark new functionalities and connect across development groups to drive value creation.
• Advance pipeline by collaborating with process engineers, drug delivery systems engineers, and formulation scientists.
• Mentor and upskill workforce across the organization.

Kenntnisse

Leadership

Biologics

Cross-functional teamwork

Lean manufacturing

Digital tools

Process development

Regulatory filings knowledge

Ausbildung

Bachelor's degree in Engineering/Science

Advanced degree preferred

Jobbeschreibung

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.

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