Analytical Development Specialist Chromatography
Analytical Development Specialist Chromatography
Galileilaan 19, 2845 Niel, Belgium
The QC Associate is a hands-on person responsible for performing routine analytical testing in support of Quality Control and Process Development and performing general laboratory operations in support of mRNA drug substance and drug product manufacturing. He/she assists in the different aspects of the method lifecycle within QC to ensure that methods are fit for their intended purpose throughout the product lifecycle.
The QC Associate 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 and Duties
The Analytical Development Specialist Chromatography’s duties shall include, but not be limited to:
Primary responsibility will be the phase-appropriate development, qualification/validation, implementation and transfer of QC liquid chromatography methods, both internally as with external partners to support the manufacturing, characterization and release of DNA start material, raw materials, lipids, mRNA Drug Substance and Drug Product.
Manage analytical development by applying an AQbD approach and assure implementation of QC methods are in line with business requirements and priorities, in compliance with the current international and Belgian laws, ICH guidelines, cGMP regulations and according eTheRNA’s internal standards and procedures.
Interact very closely with the Process Development department regarding analytical support in order to ensure that Process Development and QC activities are aligned with respect to process improvement.
Interact very closely with the Process Development department in order to ensure that Process Development and QC activities are aligned.
Write procedures, protocols and reports to support the QC test method lifecycle.
Provide technical analytical support to QC group members and cross-functional teams and assist in writing regulatory filings.
Perform general QC routine characterization, release and stability testing and assist in the general laboratory operations including reagent preparation and qualification, sample/reagent/consumables stock management, equipment maintenance, lab housekeeping etc.
Document and report data and results in accordance with the current procedures, protocols and cGMP regulations and interpret generated data for compliance towards method criteria and specifications.
Monitor QC method performance and lead investigations related to QC method and equipment failures and non-conformance events and escalate accordingly.
Initiate and write quality systems documents such as events, change controls and CAPAs
Act as Subject Matter Expert for certain QC methods during internal and external data presentation and communication and as part of internal, customer and regulatory audits.
Act as a technical expert and provide mentorship to other QC members.
Establish and maintain a safe laboratory working environment.
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.
Proven and strong expertise in liquid chromatography method development and validation according to ICH guidelines with knowledge of USP <1220> regarding Analytical Procedure Life Cycle.
Broad technical expertise and mastering of several laboratory techniques like ion pair, size exclusion, reversed phase and hydrophilic interaction chromatography using a variety of detection modes like CAD, DAD, ELSD.
Expertise in mass spectrometry is a plus
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.
Strong expertise in liquid chromatography software tools like Chemstation and/or Empower is a must.
Profound knowledge of relevant and current ICH and GMP guidelines, regulations and Pharmacopoeia.
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 environment.
Affinity with working in a quality-oriented and fast-changing environment
Able to perform experimental troubleshooting and propose technical solutions
Strong oral and scientific technical written communication skills (English Language)
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 with ability to pick up on important details
Ability to foster teamwork and a collaborative atmosphere to meet project goals within the established timelines
Enthusiastic and flexible
Understanding of MS Office (Excel, Word, PowerPoint, Outlook)
An interesting, broad QC Analytical Development position with room for own input, initiatives and ideas
Be part of an organization in the exciting industry of mRNA 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