Product Development Manager

UniD is a Contract & Development Manufacturing Organization dedicated to Micro Implants for the controlled release of drugs. Its brand-new facility with its tailormade equipment & technologies allows to handle extrusion, co-extrusion as well as injection moulding-based products. Clients can benefit from unique services going from Proof of Concept to commercial manufacturing.

To manage the overall formulation and manufacturing process development activities related to customers projects, UniD is hiring a Product Development Manager.

Your mission:

The mission of the Product Development Manager consists of elaborating and ensuring the execution of UniD’s overall formulation and manufacturing process development activities (plans, work packages) of customers’ projects.

This mission is carried out in accordance with cost, quality, and customers satisfaction requirements, as well as product/process development needs and company’s objectives as key drivers.

The product development activities encompass feasibility, development, optimization, transfer, qualification/validation and monitoring, from proof-of-concept up to commercial lifecycle stages.

Your responsibilities:

The Product Development Manager is responsible of the following:

  • Elaborate and execute the product development plans/work packages for assigned customers’ projects in line with the global strategies/objectives, targeted QTPP/CQAs and customer requirements.
  • Ensure integration of company’s strategic/objectives’ drivers (e.g., high throughput screening, cost, timing…) within their projects’ product development activities.
  • Organize and manage the future Product Development Team.
  • Ensures overview and compliance with EHS / quality/ regulatory/ legal policies and/or requirements of the product development.
  • Ensure a smooth/efficient workflow and execution coordination with the operational departments/third parties (e.g. service providers…) of the product development activities (follow up, support, training, planning, data reporting and analysis…).
  • Provide technical expertise support to operations in case of troubleshooting (e.g., quality event investigations, trending…), changes or transfer, when relevant.
  • Strong contribution to formulation/process intelligence and continuous improvement program (identification of new formulation technologies, improvements to existing products…).
  • Participate in the evaluation of contract opportunities/technical feasibility of new projects to be introduced in UniD.
  • Assist N+1 in the budget definition/follow up for the product development activities. – Edit documents related to product development activities (protocols, reports…).
  • Collaborate with the Analytical Development and Process Engineering teams in the definition of the study designs.
  • Manage the assignment of Product Development team’s SMEs for the different projects, when appropriate. When relevant, attend to technical meetings customers and to project committee meetings for product development topics and ensures assigned actions follow up.
  • Contribute to internal projects program as per defined by the strategic committee. – Lead product data management analyses and review.
  • Pro-actively communicate relevant projects’ risks identified to their N+1 and/or Project Manager when appropriate.
Your responsibilities:

Your profile:

  • Master’s degree in chemistry, pharmacy, sciences or equivalent.
  • At least 10 years of experience in the field of pharmaceutical product development.
  • Proven experience of managing pharma projects with external customers.
  • Strategic abilities to organize the development sequence throughout product development lifecycle (from feasibility up to commercial stage).
  • Technical expertise with pharmaceutical/medical device grade polymer, hot melt extrusion/injection and with terminal sterilization techniques is an asset.
  • Knowledge of specific pharmaceutical rules (development, quality, regulatory) applicable to medicinal, medical device and/or combine products development (ICH Q8, ISO 13485).
  • Strong knowledge of statistical techniques applicable to life sciences. – Fluent in French and English (written/spoken).
  • Natural leadership with proven team management experience.
  • Autonomous
  • Pragmatic
  • Factual/data-based decision making
  • Open minded and curious
  • Agility
  • Solution driven
  • Integrity
  • Caring
  • Team work
  • Result-oriented
  • Good communication skills
  • Proactive and willing to work in a start-up environment.
Your profile: