Lab Operations Specialist, Biotherapeutics

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:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

Scientific/Technology

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 Lab Operations Specialist, Biotherapeutics in Malvern, PA.

Purpose: A new opportunity to be responsible for safe and compliant Analytical Laboratory Operations within a GMP laboratory environment to support development of Biotherapeutics in Bioassay Methods Development (BMD). The individual will be accountable for day-to-day operations including life cycle management of equipment, chambers, materials and maintains laboratory compliance.  

You will be responsible for:

• Operates with day-to-day autonomy, managing responsibilities with minimal supervision and serves as Subject Matter Expert for Laboratory Operations within the department. 
• Trains staff and support staff on all associated procedures and works in a cooperative manner to ensure all day-to-day activities are executed.
• Communicates effectively across all organizational levels, identifying issues and opportunities for improvement, and recognizes when to escalate issues appropriately.
• Coordinates with internal and external service teams to maintain current laboratory equipment, to include: review of field service reports, contemporaneous logbook documentation, creation of work orders, and hosts service providers.
• Supports onboarding and decommissioning activities for new or aged equipment and chambers, ensuring smooth and compliant integration or disposal.
• Serves as the system owner for chambers (freezers, refrigerators, incubators) and small equipment such as pipettes, balances, centrifuges, completing tasks within the scope of responsibilities.
• Ensures compliance with cGMP, safety, environmental standards, company policies, and maintains cleanliness in BMD laboratories. Participates in monthly Quality walkthroughs, follows up on QA findings and supports audits.
• Collaborates with the broader Analytical Lab Operations team, representing the department in cross-functional operational teams and contributing to the development of continuous improvement initiatives.
• Ensures data integrity through accurate record-keeping and maintains/upgrades information in standard databases, including equipment entitlements.

Qualifications/Requirements

• A minimum of a Bachelor's degree in Biology, Pharmacology. Immunology, Biochemistry, or other relevant field, with at least 4 years of industry experience, or a Master's degree with at least 2 years of industry experience.
• Ability to communicate effectively and respond rapidly to change is required.
• Experience working in a GxP laboratory environment is required.
• Experience with driving the completion of lab operation activities in a timely matter is required. Lab operation activities include, (but are not limited to) equipment and chamber onboarding and decommissioning; instrument preventive maintenance, calibration and qualification; reagent management and storage; shipping logistics; freezer/chamber management; lab safety and lab tidiness.
• Experience with supporting information systems such as SAP, Asset/Equipment Management systems (e.g. Maximo), Document Management Systems and/or Change Control systems is desired.
• Must be able to work independently with minimum supervision in a cooperative complex team environment to meet tight deadlines, while maintaining a positive at