Associate Scientist – Aseptic Manufacturing

Ardena Careers; Oost-Vlaanderen; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading contract development organization in Oost-Vlaanderen is seeking an Associate Scientist specializing in Aseptic Manufacturing. The role involves participating in small-scale GMP manufacturing, executing manual operations for sterile injectables, and adhering to quality standards. The ideal candidate will have a Bachelor’s in pharmaceutical techniques and experience in a cleanroom environment. An attractive remuneration package and professional growth opportunities are offered.

Prestations

Flexible working hours

32 days holiday per year

Meal and eco vouchers

Group and hospitalization insurance

Allowance for daily commute

Qualifications

• Experience in working in a cleanroom within a GMP quality system.
• Hands-on experience in an aseptic/sterile environment is a plus.
• Good command of the English language (both written and verbal).

Responsabilités

• Participate in small-scale GMP manufacturing for new chemical entities.
• Execute manual operations like filling and capping of vials.
• Follow detailed Batch Record Documentation accurately.

Connaissances

Cleanroom experience

Attention to detail

Communication skills

Teamwork

Quality oriented

Formation

Bachelor's Degree in pharmaceutical laboratory techniques

Description du poste

About Us

Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.

The Ardena Group is operating from five sites in Europe and one in US.

For the Ardena Business Unit Drug Product Development and Manufacturing (DDM) based in Ghent (Belgium), we are looking for an Associate Scientist - Aseptic Manufacturing.

YOUR KEY ROLE

The main role as Associate Scientist – Aseptic Manufacturing is to actively take part in small-scale GMP manufacturing for new chemical entities and new treatments under the guidance of the Group Leader – Aseptic Manufacturing.

As an Associate Scientist – Aseptic Manufacturing, you will be working in Ardena Gent’s brand new Fill & Finish facility on e.g. sterile solutions intended for injectables. Activities mainly involve executing manual operations, such as manufacturing of parenteral solutions (containing small molecules or protein-based drugs), filling and capping of vials using high-end equipment in an isolator.

In order to perform these GMP activities in line with the authority guidelines, you will follow a detailed Batch Record Documentation (BRD) to execute this protocol step by step. Furthermore, you will always work in a team of at least 2 other technician and/or scientists.

YOUR PROFILE

• Bachelor’s Degree in pharmaceutical laboratory techniques, pharmaceutical assistant or equivalent.
• You have experience in working in a cleanroom within a GMP quality system.
• Hands-on experience on working in an aseptic/sterile environment (LAF cabinet or isolator) is a plus.
• You are eager to learn.
• You are quality minded and well-organized (e.g. documentation, etc.).
• You act according to our values (we CARE):
• Good command of the English language (both written and verbal).
• You are Communicative: you are able to recognize and elevate relevant issues while being a team player and have an open mindset.
• You are Accountable: you take initiative and responsibility for the projects you work on. You stay positive in all circumstances.
• You are Reliable: you have an eye for detail while working accurate & precise. You are able to keep accurate records and follow procedures. Routine does not scare you.
• You strive in Excellence: you have a “Yes we can” mentality and are willing to learn new techniques and perform multiple tasks simultaneously.

WE OFFER

An attractive and tailor-made remuneration package including extra-legal benefits such as:

• An attractive and progressive salary system including relevant extra-legal benefits (meal and eco vouchers, group + hospitalization insurance, allowance for daily commute, etc.)
• Flexible working hours
• 32 days holiday per year
• Ability to grow your skills in a dynamic and rapidly growing company with an international customer portfolio