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**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 Senior Scientist, Biologics Analytical Development - Reference Material and Critical Reagents. This role is located in Malvern, PA.
Purpose: The Senior Scientist, Reference Material and Critical Reagents (RMCR), is part of the Analytical Development (AD) Proteins organization and is responsible for delivering reference materials and critical reagents to support analytical testing for the lifecycle of the biologics portfolio. The Senior Scientist will be highly challenged in a fast paced, global, GMP environment supporting multiple biologics programs.
You will be responsible for:
- Successfully delivering on supply of RMCRs without impact to analytical testing timelines.
- Supporting storage and distribution of RMCRs globally.
- Managing preparation of RMCRs per protocol.
- Maintaining qualification and requalification schedules for RMCRs and collaborating with analytical testing labs to acquire the data necessary to prepare qualification and requalification documents and issue Certificates of Analysis.
- Collaborating and coordinating with analytical testing labs to ensure testing is executed to support RMCR activities to meet accelerated project timelines.
- Working with sites and statisticians to compile trending data as appropriate for reference materials and analytical controls.
- Authoring SOPs, protocols, and specifications to support project needs.
- Driving continuous improvement and shaping future strategies.
Qualifications / Requirements:
Education:
- Ph.D. in Chemistry, Biology, Biochemistry, or a related field with at least 2 years OR M.S. with at least 4 years OR B.S. with at least 6 years of relevant industry experience is required.
Required:
- Experience working in GMP environment.
- Experience with analytical methods and understanding of the reference material and critical reagents associated with method execution.
- Strong leadership skills.
- Strong technical writing experience (SOPs, protocols, and qualification reports).
- Highly organized and strong attention to detail to independently plan, implement, and document work.
- Excellent interpersonal skills with the ability to adapt effectively to constantly evolving organization issues, structures, and dynamics.
- Strong written and verbal communication skills to collaborate with internal teams, external vendors, and stakeholders.
- Proven ability to lead multiple projects simultaneously and to collaborate with multiple sites to ensure timely completion of activities.
- Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, OneNote, and Copilot).
Preferred:
- Experience with reference material and critical reagent sourcing, qualification, and management.
- Knowledge of automation systems and digital platforms (i.e., LIMS, BIOVIA).
- Experience with authoring regulatory filings and responses (focus on Reference Material).
- Basic understanding of data trending and experience with statistical software applications (i.e., JMP, Minitab).
- Experience with Document Management Systems (i.e., TruVault, Documentum).
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.
#LI-Hybrid
**Required Skills: **
Preferred Skills: