New Product Introduction Drug Substance Lead

BE2062

DPS Group Belgium is looking for a NPI DS Lead for a pharmaceutical project in Mechelen.

Category:
Project Manager
Location:
Belgium
Years of Experience Req.:
+5 years
Date Posted:
12/11/2020
Days Remaining:
5
Employment Type:
Contract

DPS

DPS is a leading Project Management and Engineering Company serving industries around the world for over 40 years. Specialising in the life sciences, medical technologies, oil and gas, energy and advanced technologies sectors, the Group provides consultancy and process engineering expertise to leading clients globally via their four operating business units.

One of these business units is DPS Contract Services. They provide contingent contract and temporary labour to the existing customer base within the engineering field for clients in the scientific and technology sectors throughout Europe via their network of offices located in Ireland, UK, Belgium and Holland. They also provide engineering staff to the various DPS divisions on a contract basis.

Scope of the job

Our client will be introducing new, self-developed medicinal products to the market. The role of the New Product Introduction group herein is key by acting as the link between CMC development teams and the commercial supply chain.

Therefore, as a DS lead you will work closely together with both these departments as well as with Quality, Regulatory, Contract Manufacturing Organisations (CMOs) and our partner Gilead. The DS lead “owns” and manages all DS related activities within the NPI process.

Your role

The primary accountabilities in this role are:

-        Contribute in process design and scale-up studies managed by the CMC development teams  (CMA, CPP and CQA identification, product and process monitoring strategy)
-        Ownership and management of the VMP activities of the assigned drug product(s)
-        Determine the process validation and product stability strategy and lead validation studies
-        Selection and management of external service providers (CMOs) for the Drug Substance (DS) manufacturing in alignment with CMC teams and in collaboration with procurement team
-        Lead the launch planning
-        Continue to “own” the assigned DS’s during the commercial lifecycle:

o  Lead investigations and deal with issues, non-conformances, complaints, OOS or changes while ensuring effective corrective and/or preventive actions.
o  Perform annual product review
o  Applying continuous process verification 
o  Ensure business continuity
o  Manage improvement project and Product transfer project

 

 Who are you?

You have minimum five years of proven experience in this field, more specifically you have:

-        Experience in Biotech, Biopharmaceutical or Pharmaceutical, specifically in New Product Introduction Environment
-        Experience setting up and maintaining collaboration with external partners and vendors;
-        Experience in VMP, Process Validation, Product Stability, Technology Transfer and Risk Assessment
-        Expert knowledge of Drug Substance manufacturing processes, with strong chemical background
-        Understanding of drug development process and NDA/MAA submissions
-        Demonstrated capabilities in problem solving, project management, APRs
-        Ability to effectively prepare and/or evaluate documentation.

Some key personal attributes are:

-       Excellent interpersonal, listening & communication skills
748067.978437
e="3">-    Well-organiz748067.978437ed, pro-active, planner, achievement oriented
748067.978437e="3">-   Ability to make decisions in a complex environment
748067.978437
e="3">-    Ambition to innovate, desire to learn and eager to propose new ways of working

 

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