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:

R&D Product Development

Job Sub Function:

R&D Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

US004 PA Malvern - 200 Great Valley Pkwy

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 Project Manufacturing Process Specialist (Upstream) to be in Malvern, PA.

Purpose: The Biologics Clinical Operations & External Partnerships (BCO & EP) department is responsible for the production of Biologics Drug Substance (DS) clinical supplies at 3rd party contract manufacturing organizations (CMO’s), Drug Product/Drug Substance (DPDS) internal sites, and Innovative Medicine Supply Chain (IMSC) internal sites. The Malvern Clinical Operations (MCO) team is responsible for manufacturing the Biologics DS (drug substance) clinical supplies at the Malvern manufacturing site. The Project Manufacturing Process Specialist position in Malvern acts as a key technical subject matter expert (SME) in Biologics DS (drug substance) manufacturing, providing technical support during tech transfer NPI (new product introduction) processes and clinical GMP manufacturing operations to ensure the manufacturing and delivery of DS (drug substance) clinical materials per CMC (Chemistry Manufacturing & Control) timelines.

You will be responsible for :

• Provide primary production and technical support for monitoring and troubleshooting of both UPS (upstream) and DSP (downstream) clinical manufacturing processes.
• Provide technical support for the preparation of clinical medias and buffers.
• Responsibility for the monitoring and troubleshooting of process equipment, DCS (Distributed Control System) and PLC (Programmable Logic Controller) control systems.
• Investigate and resolve issues raised during the clinical manufacturing process (atypical events, deviations, NCs, DOs). Author/Review/Approve QEM (Quality Event management) records.
• Act as the lead core team member or extended team member for the tech transfer/NPI projects.
• Create, review, and revise any necessary manufacturing documentation/systems files including SOPs (Standard Operating Procedures), Work Instructions, Master Batch Records, System Method Files, and Automation Batch Recipes as per site procedures and GDP.
• Provide support for the review and approval of completed batch records including resolving any quality issues identified.
• Provide direct technical support, as needed, for Operations/Manufacturing projects and base business initiatives, including but not limited to: equipment and materials designs, cleaning validation, process validation, equipment installation qualification (IQ) and operational qualification (OQ), re-qualification, maintenance, internal and external regulatory audits.
• Participate in and lead cross-functional teams, as necessary.
• Identify continuous improvement opportunities and lead/support implementation of improvements.
• Prioritize and schedule activities to support business needs and meet the Master Production Schedule requirements.
• Track QEM records, events, key process parameters and process performance and provide reports to management on status and trending, recommending corrective actions for identified trends as required.
• Provide process and equipment-related training, as required, within the Operations/Manufacturing department.
• Support equipment startup and technical training, assuring regulatory compliance and technical feasibility of proposed changes.

Qualifications / Requirements:

Education:

• A minimum of a bachelor’s degree in Life Sciences or Engineering is required. An advanced degree is preferred.

Experience & Skills:

Required:

• A minimum of 2 years of experience within a GMP regulated environment is required.
• Working knowledge of cGMP’s and Agency requirements for biopharmaceutical manufacturing is required.
• Knowledge of at least one of the following API upstream or downstream manufacturing processes are required: pre-culture, cell culture and harvest, chromatography, viral inactivation, or UF/DF filtration.
• Knowledge of clinical or commercial biologics drug substance (DS) manufacturing is required.
• Working knowledge of SAP, TrackWise/Comet, LIMS, MES, and GMP automation systems is required.
• Understanding of planning, material handling, manufacturing, and GMP compliance related to the manufacturing of biopharmaceuticals is required.
• Ability and willingness to work in highly ambiguous situations under stressful conditions is required.
• Ability and willingness to work effectively and efficiently with little supervision while maintaining control over current projects and responsibilities is required.

Preferred:

• Understanding of the following facility and site operations areas are preferred: facility design, HVAC, process utilities, room and equipment cleaning, equipment qualification and process validation.
• Eagerness to apply project management tools to lead projects and programs is preferred.
• Desire to increase knowledge of J&J Flawless Project Execution (FPX) philosophy is preferred.

Other:

• Standard work schedule allowed by project schedules/demands – standard Monday-Friday day shift.
• When required for project support, off shift coverage as needed 24/7/365.
• This position may require up to 10% travel.

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.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.