Scientist, Analytical Services/Validation
DescriptionThis is a research position working on analytical method validation of regulated products.
Through analytical testing, this position is focused on forced degradation studies to determine impurity profiles and the stability indicating aspects of the formulation/analytical technique.
This process must ensure compliance with corporate and global regulatory requirements.
This position will be responsible for some method development and must be proficient with ICH/FDA regulations and analytical instrumentation including LC, GC and ICP.
Knowledge of extractables and leachables would be preferred.
Also responsible for maintaining data integrity via notebook review/approval, audit trail review/approval, performing software backups, creating, and executing performance qualification protocols, generating and reviewing testing protocols and reports, ensuring system/user access is maintained and GDP is followed.
Provides technical/analytical support to Global QA Laboratories.
Must have excellent communication skills, ability to develop new/improve current processes, have excellent organizational skills, time management skills, be able to interact with senior management and regulatory authorities.
70 %:
Creating/Improving Laboratory processes around degradation, impurity control and extractables and leachables in formulations15%:
Maintaining data integrity via notebook review/approval, audit trail review/approval, performing software backups, creating and executing Performance qualification protocols, generating validation protocols and reports, ensuring system/user access is maintained and GDP is followed10 %:
Coordinates workflow based on corporate timelines.
Executes protocols with validation team.
Organizes and approves data for the validation team.
Writes/reviews/approves protocols, reports, Test Methods and SOPs.
5 %:
Provides assistance to Global QA and QAS Labs.
Qualifications:
Bachelor's Degree in Chemistry Related Field (Masters is preferred).
3-5 Years ExperienceExtensive knowledge of Analytical Instrumentation, Chemistry, Pharmaceutical regulations and Pharmaceutical Industry in general, especially focused on impurity profiling, extractables and leachables, method validation, forced degradation and stability indicating studies.
Excellent written and verbal communication skills.
Ability to manage many critical processes simultaneously.
Ability to communicate results and important findings to internal and external departments and write technical reports for Governmental Agencies, Legal and Senior Management.
The anticipated base salary range for this position is $60,500 to $90,500.
Exact salary depends on several factors such as experience, skills, education, and budget.
Salary range may vary based on geographic location.
In addition to base salary, this position is eligible for participation in a highly competitive bonus program with possibility for overachievement based on performance and company results.
In addition, The Este Lauder Companies offers a variety of benefits to eligible employees, including health insurance coverage, wellness and family support programs, life and disability insurance, retirement savings plans, paid leave programs, education-related programs, paid holidays and vacation time, and many others.
Many of these benefits are subsidized or fully paid for by the company.
Recommended Skills Communication Coordinating Food Safety Instrumentation Pharmaceutical Regulations Pharmaceuticals Estimated Salary: $20 to $28 per hour based on qualifications.
Through analytical testing, this position is focused on forced degradation studies to determine impurity profiles and the stability indicating aspects of the formulation/analytical technique.
This process must ensure compliance with corporate and global regulatory requirements.
This position will be responsible for some method development and must be proficient with ICH/FDA regulations and analytical instrumentation including LC, GC and ICP.
Knowledge of extractables and leachables would be preferred.
Also responsible for maintaining data integrity via notebook review/approval, audit trail review/approval, performing software backups, creating, and executing performance qualification protocols, generating and reviewing testing protocols and reports, ensuring system/user access is maintained and GDP is followed.
Provides technical/analytical support to Global QA Laboratories.
Must have excellent communication skills, ability to develop new/improve current processes, have excellent organizational skills, time management skills, be able to interact with senior management and regulatory authorities.
70 %:
Creating/Improving Laboratory processes around degradation, impurity control and extractables and leachables in formulations15%:
Maintaining data integrity via notebook review/approval, audit trail review/approval, performing software backups, creating and executing Performance qualification protocols, generating validation protocols and reports, ensuring system/user access is maintained and GDP is followed10 %:
Coordinates workflow based on corporate timelines.
Executes protocols with validation team.
Organizes and approves data for the validation team.
Writes/reviews/approves protocols, reports, Test Methods and SOPs.
5 %:
Provides assistance to Global QA and QAS Labs.
Qualifications:
Bachelor's Degree in Chemistry Related Field (Masters is preferred).
3-5 Years ExperienceExtensive knowledge of Analytical Instrumentation, Chemistry, Pharmaceutical regulations and Pharmaceutical Industry in general, especially focused on impurity profiling, extractables and leachables, method validation, forced degradation and stability indicating studies.
Excellent written and verbal communication skills.
Ability to manage many critical processes simultaneously.
Ability to communicate results and important findings to internal and external departments and write technical reports for Governmental Agencies, Legal and Senior Management.
The anticipated base salary range for this position is $60,500 to $90,500.
Exact salary depends on several factors such as experience, skills, education, and budget.
Salary range may vary based on geographic location.
In addition to base salary, this position is eligible for participation in a highly competitive bonus program with possibility for overachievement based on performance and company results.
In addition, The Este Lauder Companies offers a variety of benefits to eligible employees, including health insurance coverage, wellness and family support programs, life and disability insurance, retirement savings plans, paid leave programs, education-related programs, paid holidays and vacation time, and many others.
Many of these benefits are subsidized or fully paid for by the company.
Recommended Skills Communication Coordinating Food Safety Instrumentation Pharmaceutical Regulations Pharmaceuticals Estimated Salary: $20 to $28 per hour based on qualifications.
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