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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Biotherapeutics R&D

Job Category:

People Leader

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 Scientific Manager, Biologics Analytical Development to be located in Malvern, PA.Purpose:

The Scientific Manager, Reference Material and Critical Reagents (RMCR), is part of the Analytical Development (AD) Proteins organization and is responsible for shaping strategy and delivering on reference materials and critical reagents to support analytical testing for the lifecycle of the biologics portfolio.

You will be responsible for:

• Leading a team to efficiently deliver on supply of RMCRs without impact to analytical testing timelines.

• Managing storage and distribution of RMCRs globally

• Managing preparation of RMCRs per protocol.

• Driving qualification and requalification schedules for RMCRs, and work with analytical labs to acquire the data necessary to prepare qualification and requalification documents and issue Certificate of Analysis.

• Collaborating and coordinating with analytical testing labs to ensure testing is completed to support RMCR activities, meeting accelerated project timelines.

• Working with sites and statisticians to compile trending data as appropriate for reference materials.

• Authoring SOPs, protocols, and specifications to support project needs.

• Driving continuous improvement and shaping future strategies.

Qualifications/Requirements Education:

• A minimum of a Bachelor's degree in Chemistry, Biology, Biochemistry or a related scientific field with 8+ years of relevant industrial experience is required. An advanced degree is preferred.

Experience and Skills:

Required:

• Prior managerial experience is required.

• Experience working in a GMP environment is required.

• Experience with analytical methods and understanding of the critical reagents associated with method execution is required.

• Strong matrix leadership skills is required.

• Strong technical writing experience (SOPs, protocols, and qualification reports) is required.

• Highly organized to independently plan, implement, and document work is required.

• Excellent interpersonal skills with the ability to adapt effectively to constantly evolving organization issues, structures, and dynamics is required.

• Strong written and verbal communication skills to collaborate with internal teams, external vendors, and partners is required.

Preferred:

• Knowledge of automation systems and digital platforms (e.g., LIMS, Biovia) is highly preferred.

• Experience with authoring regulatory filings and responses (Reference Material focus) is preferred.

• Basic understanding of data trending and experience with statistical software applications is preferred.

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.

Required Skills: Preferred Skills:

Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Quality Assurance (QA), Scientific Research, Team Management, Technical Credibility