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’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.


Claudine Lachman

Are you interested?

Do you have any questions or do you want to apply for this position? Please fill out the form below. We will contact you if we see a good fit.
Talk to you soon!