Method Development & Validation Specialist

Braine-l'Alleud - Belgium

Monthly Salary: Not Disclosed

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

Collect information required for the analytical target profile from Project (analytical lead project manager product owner).
Propose and test candidate analytical techniques potentially able to meet expected needs.
Develop robust & efficient analytical methods with no/limited assistance utilizing modern & stateoftheart statistical approaches to bring them to successful validation.
Collect data from development and take decisions / propose solutions based on obtained results. Prepare support and present development status in technical team review meetings.
Assure that complex technical data are reported with scientific excellence and communicate the outcome of the analytical activity to team/supervisor/customer.
Understand and master all regulatory requirements pertaining to analytical method performance.
Contribute and/or collaborate to analytical method validation/co-validation/transfer both internally or external labs.
Design complex study designs and write associated Quality documents (protocols reports procedures).
Document results in laboratory notebooks according to established GDP procedures.
Advise supervision and customer when facing issues and propose options to meet timeline/define new timeline.
Participate in method comparability/equivalence studies to enable continuation of the analytical method lifecycle.
Interact with crossfunctional teams of analytical experts with internal/external labs/suppliers.
Identify risks issues and opportunities and communicate to supervisor and customer.
Collaborate to investigations in complex analytical issues corresponding to atypical or outofspecification/trend test results and instrumentation/methodology issues.

Qualifications :

Holds a masters degree in chemistry/Analytical chemistry or a similar field.
We are looking for candidates who have more than 4 years of experience.
Strong technical knowledge of various analytical techniques especially Liquid Chromatography with significant experience in development validation/verification/transfer and troubleshooting.
Understanding of interactions with other disciplines: Formulation Process Development Regulatory Affairs QA.
Strong knowledge of compendial and other applicable regulations.
Fluent communication skills in English; French is nice to have.
Basic project management skills.
The candidate must show Ownership critical mindset and out of the box thinking.
Ability to operate in certified environments.
Eagerness to learn new analytical techniques.
Knowledge of new analytical strategies (ICH Q14 QbD).

Additional Information :

A full-time (40hours/week) Monday Friday job.
Job location: Braine lalleud
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.
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.

Remote Work :

Employment Type :

Full-time

Collect information required for the analytical target profile from Project (analytical lead project manager product owner).Propose and test candidate analytical techniques potentially able to meet expected needs.Develop robust & efficient analytical methods with no/limited assistance utilizing mode...

Collect information required for the analytical target profile from Project (analytical lead project manager product owner).
Propose and test candidate analytical techniques potentially able to meet expected needs.
Develop robust & efficient analytical methods with no/limited assistance utilizing modern & stateoftheart statistical approaches to bring them to successful validation.
Collect data from development and take decisions / propose solutions based on obtained results. Prepare support and present development status in technical team review meetings.
Assure that complex technical data are reported with scientific excellence and communicate the outcome of the analytical activity to team/supervisor/customer.
Understand and master all regulatory requirements pertaining to analytical method performance.
Contribute and/or collaborate to analytical method validation/co-validation/transfer both internally or external labs.
Design complex study designs and write associated Quality documents (protocols reports procedures).
Document results in laboratory notebooks according to established GDP procedures.
Advise supervision and customer when facing issues and propose options to meet timeline/define new timeline.
Participate in method comparability/equivalence studies to enable continuation of the analytical method lifecycle.
Interact with crossfunctional teams of analytical experts with internal/external labs/suppliers.
Identify risks issues and opportunities and communicate to supervisor and customer.
Collaborate to investigations in complex analytical issues corresponding to atypical or outofspecification/trend test results and instrumentation/methodology issues.

Qualifications :

Holds a masters degree in chemistry/Analytical chemistry or a similar field.
We are looking for candidates who have more than 4 years of experience.
Strong technical knowledge of various analytical techniques especially Liquid Chromatography with significant experience in development validation/verification/transfer and troubleshooting.
Understanding of interactions with other disciplines: Formulation Process Development Regulatory Affairs QA.
Strong knowledge of compendial and other applicable regulations.
Fluent communication skills in English; French is nice to have.
Basic project management skills.
The candidate must show Ownership critical mindset and out of the box thinking.
Ability to operate in certified environments.
Eagerness to learn new analytical techniques.
Knowledge of new analytical strategies (ICH Q14 QbD).

Additional Information :

A full-time (40hours/week) Monday Friday job.
Job location: Braine lalleud
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.
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.

Remote Work :

Employment Type :

Full-time

Key Skills

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About Company

Eurofins

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more

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