Experienced Scientist, Reference Material and Critical Reagents

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 an Experienced Scientist, Reference Material and Critical Reagents.

Purpose: The Scientist Biologics AD will be part of the dynamic Process Analytical Sciences (PAS)-Reference Material and Critical Reagents (RMCR) team within Analytical Development (AD), Therapeutics Development & Supply (TDS), with a specific focus on the storage and distribution, preparation, qualification, requalification, and lifecycle management of reference materials (RMs) and critical reagents (CRs). The Scientist Biologics AD will be highly challenged in a fast paced, global, GMP environment supporting multiple large molecule (protein and cell & gene therapy) programs. The Scientist Biologics AD will work in a team environment, as well as contribute individually to meet accelerated timelines for project goals. Responsibilities of the Scientist Biologics AD will include, but are not limited to, leading reference material and critical reagent preparation, storage and distribution activities, and qualification and requalification of materials by partnering with testing labs, method development SMEs, and outsourced partners.

You Will Be Responsible For

• Maintain qualification and requalification schedules for RMs/CRs and work with sites to acquire the data necessary to prepare
• qualification and requalification documents and issue Certificate of Analysis.
• Collaborate and coordinate with sites and analytical testing labs to ensure testing needed to support RMCR activities meets
• accelerated project timelines.
• Work with sites and statisticians to compile trending data as appropriate for reference materials.
• Author SOPs, protocols, and specifications to support project needs.
• Collaborate to drive strategy of RMs and CRs for new modalities as well as refine those that are already established to ensure
• alignment with Health Authority expectations for early, late development, and commercial portfolio.
• Perform analytical testing as needed as part of reagent preparation and qualification.
• Follow general laboratory safety procedures.
• Attend AD sub-teams and cross-functional project meetings as representative for RMCR.
• Lead storage and distribution activities for RMs and CRs.
• Prepare and coordinate appropriate RMs and CRs.
• Participate in continuous improvement initiatives for RMCR processes.
• Work in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.
• Build strong collaborations and focus attention to customer needs.
• Prepare regulatory filing sections and make presentations at AD governance and for other cross functional teams.
  
  

Qualifications

Education:

• Minimum of a Bachelor's degree with a minimum of 4 years of relevant experience is required.
  
  

Required

Experience & Skills:

• Ability to creatively solve technical problems while meeting accelerated project timelines is required.
• Highly organized to plan, implement, and document work with limited guidance is required.
• Capability of working in a cross-functional team environment with a positive attitude is required.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, and OneNote) is required.
• Strong technical writing experience (SOPs, protocols, and qualification reports) is required.
• Ability to lead multiple projects simultaneously and to collaborate with multiple sites to ensure timely completion of activities is required.
• Highly self-motivated and eager to learn.
• Excellent communication skills (written, oral, and presentation) are required.
• Solid understanding of release and stability testing of large molecules is required.
• Excellent accuracy and strong attention to detail when reporting data within documents are required.
• Ability to implement procedures and processes and to present findings to management is required.
  
  

Preferred

• Protein chemistry experience with HPLC, ELISA, Bioassay, Capillary Electrophoresis, Characterization, and cIEF is preferred.
• Basic knowledge of cell & gene therapy is preferred.
• Experience with reference material and critical reagent sourcing, qualification, and management is preferred.
• Knowledge of cGMP regulations, FDA guidance, and process excellence methodology is preferred.
• Experience with Document Management Systems (i.e., TruVault, Documentum) is preferred.
• Experience with LIMS is preferred.
• Basic understanding of data trending and experience with statistical software applications (i.e., JMP, Minitab) is preferred.
• Experience writing regulatory filings is preferred.
  
  

Other

• Focus on achievement and delivery of results with high sense of urgency.
• No travel required.
  
  

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.