Senior Scientist Drug Product Development

작업 내용

General Job Description

The Senior Scientist Drug Product Product Development is a member of the Manufacturing team, subteam Product Development. This position reports into the Head of Product Development. The individual is accountable for formulation process technological transfer from preclinical, formulation product development, upscaling the fill/finish process and improvement and follow up of contractors.

This position is based in Gent, Belgium and Niel, Belgium.

Responsibilities and Duties

The Senior Scientist Drug Product Development’s duties shall include, but not be limited to the following tasks:

• Leads formulation and fill/finish process development of specific projects and the implementation in a GMP setting. Supports the transition of these processes from prototype to full production for clinical human use, in-house and together with contractors;
• Support early development activities in the set-up and selection of formulation and processes in order to guarantee manufacturability in GMP setting
• Defines deliverables and requirements to preclinical team for stage gate review prior to transfer technology to formulation process development
• Designs and develops formulation and filling processes for manufacturing and associated validations using principles of process excellence;
• Involved in process improvement, process optimization, technology transfer, upscaling and process validation activities to meet agreed- upon objectives and regulatory requirements;
• Provides support in manufacturing decision-making information by calculating production, labour, and material costs;
• Develops, writes, and reviews technical and quality system documents;
• Perform and support the required quality risk assessments in the manufacturing environment;
• Supports the manufacturing organization in creating the necessary documentation and providing training as a result of new processes or process improvements;
• Provide hands on support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements in relation to process failures. Collect and analyse data to make data driven recommendations/decisions;
• Build and maintain successful cross-functional relationships within the company;
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

Job Requirements

Education

Engineering degree in Biotechnology/Biochemistry, Industrial Pharmacist, PhD/MS in biology, (bio)medicine, life sciences or equivalent (process industry).

Experience

• Minimum of five years of relevant industrial GMP experience (preferably hands-on experience in a bio-manufacturing environment);
• Minimum five years of relevant experience in formulation development
• Broad process technological expertise.
• Experience in lipid nanoparticle technology or other advanced formulation technology is a plus
• Experience in freeze/spray-drying or other stability improving technologies is a plus

Other Qualifications, Skills and Abilities

• Detail-oriented and accurate in following instructions, record keeping and completion of reports;
• Affinity with GMP guidelines and working in a quality-oriented environment. Experience in aseptic process manufacturing and process validation is a plus;
• Able to perform experimental trouble-shooting and propose technical solutions;
• Analytical and solution-oriented mindset;
• Good organizational capacities and detailed documentation practices;
• Training in Six Sigma and Lean Manufacturing a plus;
• Project management skills are a plus
• Good knowledge of English;
• Good communication skills;
• Well organized, well-structured, hands-on, result focused;
• Able to work under stringent time lines:
• Ability to foster teamwork and a collaborative atmosphere;
• Enthusiastic, flexible and able to multitask;
• Understanding of MS Office (Excel, Word, PowerPoint, Outlook).

Our offer

• An interesting, broad science Product Development position with room for own input, initiatives and ideas
• Be part of an organization in the exciting industry of RNA Therapeutic Technologies
• Contract of indefinite duration and a salary package according to the standards of the biotech industry with a nice package of extra benefits
• Working within an innovative group with nice colleagues