NEW IN : Global Head Product Development and Commercial Supply

Management Responsibilities

  • Day to day management of the PDCS function;
  • Budget responsible for the PDCS function;
  • Translate The client’s organizational goals and priorities into performance objectives for the PDCS function;
  • Define, prioritize and evaluate performance objectives;
  • Inform the Global Head of Development on potential resource shortfalls and of other problems relating to the PDCS activities;
  • Ensure that The client’s management and PDCS staff are adequate informed of product supply strategies and initiatives.

Product Supply Responsibilities:

  • Ensure a global supply of commercial drug substance, drug product and administration kit that meets The client’s commercial needs
  • Responsible for the physical movement of the product from the manufacturing site to the end customer;
  • Ensure a supply of clinical trial material that meets The client’s development needs;
  • Ensure that all product supply activities are delivered to the right quality, on budget and on time;
  • Define and implement clinical and commercial manufacturing strategies;
  • Set technical and business strategies for product supply;
  • Negotiate commercial supply agreements.

Product Development Responsibilities

  • Set technical and business strategies for development of new products and improvement of existing products;
  • Ensure that the CMC development matches the clinical development stage of the product from a regulatory perspective;
  • Provide strategic and technical input to CMC activities such as:

* characterization, analysis and specifications

* product development, process development, validation and scale-up

* formulation development

* product life-cycle management

  • Responsible for the technical content of all product development activities

Compliance responsibilities

  • Ensure that the manufacture and distribution of commercial product is in compliance with cGMP/GDP;
  • Ensure that the manufacture of clinical trial material is in compliance with cGMP;
  • Ensure that quality agreements are in place, appropriate, up-to-date and agreed with Quality Assurance;
  • Ensure that the manufacturing process and product specifications of clinical trial material are appropriate for the intended clinical purpose;
  • Ensure that the manufacturing activities will be performed in compliance with the appropriate internal and external quality and technical guidelines (e.g. internal SOP’s, ICH, cGMP);
  • Ensure that all CMC documents meet the required technical and quality standards as required in guidelines (e.g. ICH, cGMP) and are appropriate to support the intended regulatory submissions;
  • Write/review SOP’s as required to support The client’s Quality Management System in collaboration with The client Quality Assurance Unit;
  • Ensure that the necessary actions are taken based on recommendations of Audit Reports from Quality Assurance at The client;
  • Write, assemble, review and approve technical documentation required for regulatory submission of IND’s, IMPDs, BLA and MAA and ensure documents are delivered to the required standard and timeline;
  • Responsible for the technical content of CMC documents supporting regulatory filings.

Outsourcing responsibilities

  • Ensure that contractors are selected in accordance with The client’s policies for contracting out GMP, GLP and GCP work;
  • Ensure that an approved contract is in place for work contracted out;
  • Ensure that work outsources to contractors are delivered on budget, on time and to the appropriate technical and quality standards.

Required skills, education and experience:

  • PhD in a relevant scientific or technical discipline is an asset
  • Minimum 10 years of experience in managerial positions in a (bio)pharmaceutical company
  • Proven record setting and executing global strategies for the development of clinical and commercial manufacturing of biopharmaceutical products
  • A strong background in process development and commercial manufacturing of both drug product and drug substance
  • Experience with selection and management of resourcing partners for process development and manufacturing activities
  • Experience with preparation for the commercial launch of pharmaceutical products
  • Experience working in a multi-disciplinary, multi-cultured, international matrix environment
  • Strong understanding of the (bio)pharmaceutical business
  • Experience with interaction with international regulatory agencies
  • Excellent oral and written skills in English
  • Strong sense of accountability and responsibility
  • Analytical thinking and problem solving
  • Prioritization
  • Strong written and verbal communication skills
  • Strong interpersonal skills – with all levels of the internal organization and with external suppliers
  • Strong organizational skills to work in a matrix organization
  • Ability to identify, evaluate and execute new and improvement opportunities
  • Ability to motivate and coach others
  • Ability to plan and adapt the organization for short, medium and long term development
  • Result and milestone driven you are

OUR CLIENT

Our client’s goal is to prevent vision loss and fight blindness worldwide by developing and delivering next-generation treatments in ophthalmology. They aim to lower the burden of treatment for patients and enhance practice management for physicians.

They develop innovative compounds that each target a distinct, unexplored pathway to answer unmet medical needs in ophthalmology, with a focus on back of the eye disease.

They are committed to innovation through cross-disciplinary and cooperative research across the globe. Collaborating with stakeholders worldwide, they  aim to deliver solutions enabling equal, affordable vision preservation for all people.

Contact

Claudine Lachman


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