Drug Product Development Scientist Geleen • Basic Pharma

Basic Pharma is a unique Dutch pharmaceutical company that is growing at lightning speed, is constantly building its organization and is constantly specializing and developing. The company focuses on the full breadth of the pharmaceutical industry: from product development, registration, production and commercialization of (bio) pharmaceutical products to pharmaceutical services,

Basic Pharma has an ever-increasing circle of national and international customers, from start-ups to multinationals.
The production organization Basic Pharma Manufacturing makes products such as nasal sprays, filled syringes, creams and ointments. In addition, it also supplies clinical study medications and offers various services to third parties, such as quality control and contract manufacturing.

The availability and combination of all activities under one roof makes Basic Pharma a strong and versatile player within the pharmaceutical industry. Currently there are approximately 250 employees. Basic Pharma's ambitions go further and that is why we are looking for employees who are committed, who consider professionalism of paramount importance and who put the customer first. Does this appeal to you? Then the vacancy below might be something for you!

Basic Pharma Technologies is looking for a
 Drug Product Development Scientist

At Basic Pharma Technologies (BPT) we develop new products and (manufacturing) processes in a Contract Development Manufacturing Organization (CDMO) environment. This is accomplished by a dedicated multidisciplinary team of pharmaceutical experts. Since our organization is rapidly growing we are looking for an individual with experience in product and/or process development and is specialized in analytical chemistry.

In this challenging position you will participate in various project teams. Each project team is developing a new product and/or process for the own organization or for contract development. You will participate in pharmaceutical formulation and process development, both in the lab and conceptually on paper, and report the results and conclusions to the project team. During dossier submission you will take the lead in acquiring additional data to answer questions raised by the authorities, on time and to their satisfaction. In case of contract development you will be able to be in direct contact with the customer together with project management. Before and after the start of a project you may be asked to facilitate technology transfer activities to integrate manufacturing methods and procedures into a manufacturing organization.

You will:

• Reverse engineer products
• Develop new pharmaceutical formulations in case of contract development
• Set the quality target product profile (QTPP), specifications and constraints
• Develop new finished products including packaging for drug-device combinations
• Design, execute and conclude in-vitro Bioequivalence testing programs, in collaboration with development team.
• Discuss and collaborate development activities together with suppliers of primary packaging
• Design, execute and conclude drug product stress test stability studies, in collaboration with development team
• Develop, evidence based, robust and scalable manufacturing processes, with known constraints (CPP) and defined control measures (CQA) on lab and production scale
• Support primary batch manufacturing activities and
• Peer review as an SME for internal and external document release
• Take lead in answering quality assessment questions from regulators regarding pharmaceutical development
• Participate in multiple project teams.
• Bring forward ideas and solutions to the project team during project execution.
• Represent BPT during meetings with suppliers and customers.
• Collaborate with other colleagues during project execution.
• Design, execute and monitor studies and report the results and conclusions to the project team
• Facilitate internal or external tech-transfer

• You are a good organizer and keep track of tasks and priorities.
• You have experience in writing protocols and reports
• You have strong rational thinking skills
• You are critical on data and your work performance  
• You like to help and coach others
• A Master (MSc) degree in for example: (bio-) Pharmaceutical Sciences, Pharmacy, Medicinal Chemistry
• For this position 3 years of industrial work experience are required, in a GMP setting

The ideal candidate :

• Self-starter and proactive
• Strong communicator
• Enthusiastic specialist and creative problem solver
• Ambitious and curious person
• Good team-player
• Trustworthy role model within the project team and towards external contacts
• In dept knowledge of quality standards like GMP and the ICH Q8
• Knowledge of the Guideline on the Pharmaceutical quality of inhalation and nasal medicinal products is a pre
• Intermediate level statistical know-how (i.e. DoE, MSA and Process Capability Analysis)
• Basic analytical knowledge of HPLC, Droplet Size Distribution, Particle Size Distribution, and rheology
• Good command of the English language

• A dynamic work environment where you can develop methods and help bring new products from concept to market
• Opportunities for growth and personal development
• Competitive compensation with good secondary employment conditions

Acquisition in response to this vacancy is not appreciated.