Method development and Transfer Specialist (Chromatography)

工作内容

Job Description

The Method Validation and Method Transfer Specialistwill play a crucial role in the validation, verification, and transfer of analytical methods within the company. The ideal candidate will have substantial experience in analytical method validation/verification in the pharmaceutical industry and a strong understanding of Compendial and ICH requirements. This position requires basic knowledge of statistics and the ability to manage a diverse portfolio of activities including planning, resource estimation, risk identification, decision making, communication, and team leadership.

Key Responsibilities:

• Conduct and oversee analytical method validation, verification, and transfer activities in accordance with regulatory guidelines and company standards.
• Ensure compliance with Compendial (USP, EP, JP) and ICH requirements for analytical methods.
• Develop and execute method validation protocols and reports.
• Perform statistical analysis and interpretation of validation data.
• Coordinate cross-functional teams to ensure timely and successful method transfers.
• Identify and mitigate risks associated with method validation and transfer activities.
• Plan, organize, and manage resources effectively to meet project timelines.
• Communicate project status, issues, and risks to stakeholders and senior management.
• Participate in internal and external audits and regulatory inspections.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 1 year of experience in analytical method validation/verification within the pharmaceutical industry.
• Experience with chromatographic techniques (HPLC, GC) and spectroscopic methods (UV, IR).
• Good knowledge of Compendial and ICH requirements.
• Familiarity with regulatory submission processes.
• Experience with Laboratory Information Management Systems (LIMS).
• Strong project management skills, including planning, resource estimation, and risk management.
• Excellent communication and interpersonal skills.
• Detail-oriented with strong problem-solving skills.
• Proficiency in Microsoft Office Suite and relevant analytical software.
• Ability to communicate in both English and French.

Additional Information

• A full-time (40hours/week) Monday – Friday job.
• Job location: Braine l’alleud 50% and Lessines 50%
• A Permanent contract with flexible working hours.
• Work in a fast-growing international organization.
• Meal Vouchers 8 Euro/Working Day.
• Eco-Cheques +/- 250 Euro/Year.
• Company car + Fuel tank card.
• DKV Hospitalization insurance.
• Additional 12 ADV days.
• A company well-being program targeting both mental and physical well-being.
• A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment
• Personal development through learning on the job and additional trainings.