Johnson & Johnson Careers

OTC Formulation Scientist

Beerse, Belgium
Validation


Job Description

Requisition ID: 00001ELV

ENSURE HIGH PRODUCT QUALITY
  • Evaluate the potential impact of proposed changes on quality and efficacy
  • Support the change control process when applicable
  • Participate where necessary in QA-led investigations of process deviations and customer complaints. Support manufacturing trouble shooting activity and propose CAPA where applicable
  • Evaluate manufacturing instructions, specifications and amendment to each.
  • Ensure that current pharmacopeial requirements are met where applicable
  • Perform and support raw material evaluation and qualification
  • Investigate process improvements and oversee the process validation, ensuring adequate documentation is available to support successful registration of projects
  • Support request for information requests which may arise on regulatory variation submission
  • Support request for information requests which may arise on regulatory variation submission
  • Update JnJ Specification systems such as Tru, CONNECT, etc.
  • Manage the technical sections of Authorised Product Release compilation

CONTRIBUTE PRODUCT AND PROCESS ENGINEERING EXPERTISE 

  • Create pharmaceutical reports.
  • Participate in various cross-disciplinary groups in an expert capacity.
  • Support local manufacturing plant in an expert capacity
TRANSFER OF PRODUCTS
 
  • Actively participate in the Tech Transfer Team
  • Contribute expertise on product and process engineering.
  • Support Process and Analytical optimization, development and validation as required
  • Ensure transfer compliance with current J&J procedures

REFORMULATION of PRODUCTS

  • Develop product development strategies for current products on market
  • Contribute Expertise on product and process development
  • Actively participate in establishing and developing the process on a production scale
  • Create and/or Review upscaling reports
  • Ensure that adequate documentation is available to support successful registration of products

PRODUCT and PROCESS IMPROVEMENTS with regards to product quality and cost efficiency

  • Identify and propose
    • product and process improvements
    • cost improvement and business continuity plans
  • Support commercialization of secondary market launches of new product introductions
  • Ensure that adequate documentation is available to support successful registration of projects
Management of Third Parties
  • Actively participate in the selection, due diligence and evaluation of Third Party partners
  • Management of technical relationship with Third Party and provide technical supervision to assure that J&J products are produced according to J&J and International standards
FURTHER DEVELOP KNOWLEDGE AND SKILLS
  • Maintain necessary good manufacturing practice (GMP) skills through training, technical review and SOPs
  • Have a close collaboration with the Supply Chain
  • Continuously update new research findings and techniques
  • Be responsible for personal development (active participation in planning and employee reviews as well as creation and implementation of personal development plans)



Qualifications
  • Educational Requirements:

    Educational – Minimum of Bachelors degree with a major in chemistry, chemical engineering or pharmaceutics or equivalent degree.


    Work Experience:
    • A minimum of 7-8 years in a pharmaceutical manufacturing or product development environment with a major emphasis on multi-ingredient finished dose formulations.
    • Experience with non-prescription ingredients used in cough, cold & allergy preparations and analgesics is a distinct advantage.
    • Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems
    • A demonstrated business partner and ability to bring together multi-disciplined technical staff in order to problem-solve.
    • Technical writing and documentation review abilities
    • Project management, communication and prioritization skills.
    • Demonstrable experience of working with external manufacturers

Primary Location
Belgium-Antwerp-Beerse-
Other Locations
Europe/Middle East/Africa
Organization
Johnson & Johnson N.V./S.A. (7821)
Job Function
Validation
Requisition ID
00001ELV