Job Description

Global Head of Product Development and Commercial Supply

If you are a highly experienced individual in the field of CMC and CMO, who is looking for a global role, where you can bring a meaningful impact to the drug development lifecycle, then you will definitely find this position very interesting to explore!

An incubator and drug development company is looking for an energetic leader to join the company at one of their sites in Belgium as a Global Head of Product Development and Commercial Supply.

The ideal candidate should possess the following qualities:

• Experience in small molecules as it relates to the role
• Experience in negotiating with contract manufacturers and contract labs
• Experience in delivering technical agreements and product specifications files with contract manufacturers mostly
• Experience in commercializing IMPs to marketed products, including formulation, stability and up-scaling manufacturing processes
• Negotiation and leadership skills are a must
• Energetic personality with “can-do'' attitude.

In return the company offers a highly competitive salary and benefits package, as well as reallocation and tax ruling support.

Job description

The Global Head of Product Development and Commercial Supply will carry multidisciplinary strategic responsibilities such as:

 - Management & budgeting

• Devise product supply strategies and initiatives
• Devise, prioritize and evaluate performance objectives.

 - Product Supply

• Define and implement clinical and commercial manufacturing strategies
• Negotiate commercial supply agreements
• Set technical and business strategies for product supply
• Ensure a global supply of commercial drug substance, drug product and administration kit that meets commercial needs.

 - Product Development
   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.

 - Regulatory / Compliance

• Ensure compliance with cGMP/GDP as well as internal SOPs/ICH;
• Ensure appropriate quality agreements
• Write/review SOP’s to support QMS in collaboration with the QA department
• Write, review and approve technical documentation required for regulatory submission of IND’s, IMPDs, BLA and MAA
• Responsible for the technical content of CMC documents supporting regulatory filings.

 - CMO/Contract Labs Management

• Select contractors in accordance with policies for contracting out GMP, GLP and GCP work
• Ensure that work outsources to contractors are delivered on budget, on time and to the appropriate technical and quality standards.

Profile

• Masters / PhD combined with 10 years’ leading and management positions
• A solid track record in developing strategies for the development, manufacturing and supply of clinical and commercial pharmaceutical products
• A strong background in process development
• Excellent experiences in CMC development, technical transfers, CMO selection, vendor management, scale up for commercial manufacturing
• Experience in working with regulatory authorities as well as supporting regulatory submissions
• Excellent verbal and written skills in English.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact David on +44 (0)207 801 3385 in full confidence to receive more details on this role.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.

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