Associate Scientist, Biologics Analytical Development Reference Material and Critical Reagents

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 are searching for the best talent for an Associate Scientist Biologics Analytical Development - Reference Material and Critical Reagents located in Malvern PA.

Purpose: The Associate 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 Associate 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.
• Participating in initiatives for continuous improvement and future strategies.

Qualifications / Requirements:

Education: M.S. in Chemistry Biology Biochemistry or a related field with at least 1 year OR B.S. with at least 3 years of relevant industry experience is required.

Required:

• Experience with analytical methods and solid understanding of the reference material and critical reagents associated with method execution.
• Highly self-motivated and eager to learn.
• Strong technical writing experience (SOPs protocols and qualification reports).
• Highly organized and strong attention to detail to plan implement and document work with limited supervision.
• 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.
• Ability to lead projects and to collaborate with multiple sites to ensure timely completion of activities under accelerated project timelines.
• Proficiency with Microsoft Office Suite (Word Excel PowerPoint Outlook Teams OneNote and Copilot).

Preferred:

• Knowledge of cGMP regulations FDA guidance and process excellence methodology.
• Experience with reference material and critical reagent sourcing qualification and management.
• Knowledge of automation systems and digital platforms (i.e. LIMS BIOVIA).
• Basic understanding of data trending and experience with statistical software applications (i.e. JMP Minitab).
• Experience with Document Management Systems (i.e. TruVault Documentum).

#LI-Hybrid

Required Skills:

Preferred Skills: