J&J Family of Companies Principal Scientist - Raw Material Strategy F/M in Eure, France

Johnson & Johnson Consumer Europe is a leading supplier of Fast Moving Consumer Goods oriented to Health & Personal Care. Our products are produced and distributed in all major European countries and exported overseas.

Johnson & Johnson has an open culture with strong principles that have been incorporated in our company credo. This is an opportunity for you to become part of our talented team delivering to stretch targets in a dynamic business environment. We are on a journey to implement state of the art technology which comes with many opportunities to further develop your skill set.

The Principal Scientist, Raw Material Strategy will serve as the technical raw material subject matter expert and single point of contact (SPoC) for the EMEA region. This individual may serve as the backup Chair for the Material Evaluation Council. The successful candidate will serve as the Global Process Owner for the assessment and trending of Critical Material Attributes (CMAs).

They will be the facilitator of newly identified Critical Materials and/or Critical Material Attributes to Source Quality. This individual will have responsibility as the documentation author for raw material projects in support of drug product development and commercial manufacturing.

This position offers the opportunity to provide visible leadership of cross-functional teams to resolve complex problems while meeting quality, scheduling, and cost objectives. The successful candidate will be a key contributor to a dynamic and highly technical team by setting appropriate objectives and priorities, overcoming obstacles, ensuring compliance strategies are aligned with appropriate drug authorities and delivering results within project timelines.

This individual will build and maintain effective collaborations with both internal and external business partners as well as trade associations such as The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers & Affiliates (SOCMA).

This is a global role that is located in the EMEA region and will contribute to regional and global project teams as assigned.

Responsibilities:

  • Be the EMEA Single Point of Contact (SPoC) and facilitator for the technical aspects of all raw materials projects and Investigations for all raw materials (excluding packaging components) for all manufacturing partners, both Internal and external to J&J.

  • Manage and provide oversight to projects associated with raw material change (ex. internal change, supplier change or discontinuation) or dual sourcing qualification in marketed OTC finished products

  • The function holder follows up on progress for technical projects and ensures correct technical representation. The function holder drives technical strategy in these projects.

  • Be the Global Process Owner for the Assessment and Trending of Critical Material Attributes (CMAs)

  • Function holder is responsible for the technical assessment of identified critical material attributes including statistical assessment of vendor’s process control

  • Function holder will establish periodic schedule for re-assess and update statistical assessment of raw material vendors

  • Author GMP/GDP compliant technical documents including protocols, reports, white papers and SOPs supporting raw material utilization.

  • Serve as the global thought leader both internally and externally for Active Ingredients

  • Represent Johnson and Johnson as a member on relevant industry trade organizations such as the Bulk Pharmaceuticals Task Force (BPTF)

  • Created as an affiliate organization of the Society of Chemical Manufacturers & Affiliates (SOCMA), BPTF is an industry trade organization representing manufacturers of active pharmaceutical ingredients (APIs), intermediates and excipients.

  • Serve as the back-up chair for the Material Evaluation (MEC)

  • Pursue difficult and complex technical issues that have substantial impact on product quality

  • Manage communication with suppliers, internal and external plants, supply chain and procurement on raw material qualification status

  • Support Raw material strategy initiatives linked to current raw material portfolio including raw material evaluation and qualification

  • Manage raw material qualification activities that are handled by outside consulting services

  • Lead raw material compliance projects to support alignment with applicable federal agencies and/or regulatory bodies

  • Scientific contributions are likely to be components of a larger initiative

Qualifications

Requirements:

Education: Degree with engineering, scientific or pharmaceutical background

Experience: Minimum 8 years of experience with evidence of progressive increase in responsibility in pharmaceutical manufacturing, technical operations, technical quality or analytical function. Supervisory experience is not required.

Physical Demands: . Travel within region 20%. International travel 10%. Ability to perform basic laboratory actions is required.

Knowledge, Skills and Abilities:

  • Strong knowledge of GMPs, GLPs, SOPs and latest regulatory trends is required

  • Ability to influence colleagues and partners, both internal and external to J&J is required

  • Ability to share knowledge to influence colleagues in other disciplines to solve problems is required

  • Ability to independently plan, organize, coordinate, manage and execute assigned tasks is required

  • Ability to critically review data for trends and/or patterns and recommend scientific and compliance directed actions is required

  • Ability to prepare and maintain accurate and complete technical documentation is required

  • Excellent oral and written communication skills is required

  • Ability to write effective technical documents such as research reports, regulatory documents, methods, SOPs, memos, e-mail messages, etc. is required

  • Technical experience in pharmaceutical manufacturing and/or analytical development is preferred

  • Highly capable to make presentations to senior management, company meetings and external conferences is preferred

  • Ability to solve complex technical problems through investigating root causes that have significant impact on the product quality and business outcomes is preferred

  • Auditing experience is preferred

Primary Location

France-Haute-Normandie-Eure-

Other Locations

Europe/Middle East/Africa-Switzerland-Zug-Zug, Europe/Middle East/Africa-Italy-Lazio-Latina, Europe/Middle East/Africa-Spain-Community of Madrid-Madrid, Europe/Middle East/Africa-Sweden-Skåne-Helsingborg, Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization

Johnson & Johnson Santé Beauté France SAS (7101)

Job Function

R&D

Requisition ID

1805699914W