QC Analytical Development Specialist

14/10/21

Location

Galileilaan 19, Niel, Belgium

Function type

QC Analytical Development Specialist

Vacancy

The Analytical Development Specialist is responsible for the different aspects of the method lifecycle and ensures that methods are fit for their intended purpose throughout the product lifecycle. This person will be responsible for the development, qualification, validation and transfer of various HPLC/UPLC methods (ion pair chromatography, size exclusion chromatography, reversed phase HPLC, and Hydrophilic Interaction Chromatography (HILIC)) using a variety of detection modes (CAD, DAD, ELSD) and will provide support on characterization methods using liquid chromatography coupled to high-resolution mass spectrometry.

The Analytical Development Specialist is a member of the Quality Control department. This position reports to the Quality Control Manager. This position will be based in Niel, Belgium.

Responsibilities & duties

The QC Analytical Development Specialist’s duties shall include, but not be limited to:

  • Development, qualification, validation and transfer of QC methods to support the manufacturing, characterization and release of lipids, mRNA Drug Substance and Drug

  • Product.

  • Support new and ongoing analytical chromatography method development internally and with external partners.

  • Implement QC chromatography methods and ensure timely completion and delivery of project related requirements towards data delivery and documentation.

  • Write procedures, protocols and reports to support the QC test method lifecycle.

  • Interact very closely with the Process Development department in order to ensure that Process Development and QC activities are aligned.

  • Act as Subject Matter Expert during data presentation and communication on technical aspects both internally and externally.

  • Perform, under general supervision, a variety of specialized laboratory operations according to GxP requirements, ICH guidelines and current procedures and protocols.

  • Troubleshoots assay methods and equipment

  • Support root cause investigations

  • Establish and maintain a safe laboratory working environment

  • Follow training in adequacy with the function

Job requirements

Education

PhD in Analytical Chemistry, Biochemistry or related discipline with a minimum of 2 years of relevant working experience in the biopharmaceutical industry, or a MSc with minimum of 5 years of experience.

Experience

  • Strong expertise in liquid chromatography method development and validation according to ICH Q2(R1) guidelines.

  • Expertise in mass spectrometry is a plus

  • Strong expertise in liquid chromatography software tools like Chemstation and/or Empower is a must.

  • Knowledge to perform statistical data analysis and setting up Design of Experiments (DoE) by using the appropriate statistical software tool (e.g. JMP) is an asset

Other qualifications, skills and abilities:

  • Detail-oriented and accurate in following instructions, record keeping and completion of reports

  • Able to prioritize and work under stringent timelines in a highly independent manner on multiple method development projects in a dynamic and fast-growing environment.

  • Affinity with working in a quality-oriented environment

  • Able to perform experimental troubleshooting and propose technical solutions

  • Proven technical writing and communication skills to communicate scientific data effectively

  • Good organizational capacities and detailed documentation practices

  • Excellent knowledge of English, both spoken and in writing

  • Well organized, well-structured, hands-on, problem solving, result focused

  • Ability to foster teamwork and a collaborative atmosphere

  • Enthusiastic and flexible

  • Understanding of MS Office (Excel, Word, PowerPoint, Outlook)

Our offer

  • An exciting job in a dynamic and entrepreneurial environment with room for personal development

  • Employment contract of unlimited duration with a competitive salary package with a lot of extra benefits

  • Work within a dynamic and fast-growing group with great colleagues

Applications: https://careers.etherna.be/en/qc-analytical-development-specialist/apply

Job application