Scientific Manager, Biologics Analytical Development

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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.

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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 Bachelors 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 internal employees contact AskGS to be directed to your accommodation resource.

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