Senior Associate Scientist, Analytical Operations
On behalf of my client I am recruiting for a Senior Scientist in
Analytical Operations.
The successful candidate will be tasked with independently planning
and executing experiments that support routine & non-routine
development activities and project goals. This is a permanent
full-time position.
Responsibilities:
? Applies advanced level of understanding of analytical methods.
? May create API or drug product specifications
? Generation, review and approval of development & validation
lifecycle documentation including change controls, risk assessments,
protocols, reports etc
? Collation of data and technical writing for submissions for
regulatory filings.
? Planning and execution of method transfer/validations, process,
cleaning and analytical testing in accordance with validation
protocols
? Generation, review and approval of development & validation
lifecycle documentation including change controls, risk assessments,
protocols, reports etc
? Collation of data and technical writing for submissions for
regulatory filings.
? Planning and execution of method transfer/validations, process,
cleaning and analytical testing in accordance with validation
protocols
? Manage group with multiple areas of responsibility and may lead a
component of a project within the job family.
? Identifies and introduces new technology and/or methods to the
organization and trains junior staff.
? Working knowledge of GMPs, pharmacopoeial, regulatory requirements
for analytical testing, phase appropriate standards for method
validation.
? Advanced knowledge of current Good Laboratory Practices (GLPs) and
current Good Manufacturing Practices (GMPs)
Qualifications:
? Competent in the operation of Analytical Instrumentation including
Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower etc.
? Bachelor?s degree or higher in Chemistry or Biology
? Minimum of **Apply on the website** years? relevant experience
? Resilient & dynamic profile with the ability to deliver in an
ambiguous environment
? Ability to engage and manage multiple stakeholders to achieve the
objective
JOB DESCRIPTION
Senior Associate Scientist, Analytical Operations
On behalf of my client I am recruiting for a Senior Scientist in
Analytical Operations.
The successful candidate will be tasked with independently planning
and executing experiments that support routine & non-routine
development activities and project goals. This is a permanent
full-time position.
Responsibilities:
? Applies advanced level of understanding of analytical methods.
? May create API or drug product specifications
? Generation, review and approval of development & validation
lifecycle documentation including change controls, risk assessments,
protocols, reports etc
? Collation of data and technical writing for submissions for
regulatory filings.
? Planning and execution of method transfer/validations, process,
cleaning and analytical testing in accordance with validation
protocols
? Generation, review and approval of development & validation
lifecycle documentation including change controls, risk assessments,
protocols, reports etc
? Collation of data and technical writing for submissions for
regulatory filings.
? Planning and execution of method transfer/validations, process,
cleaning and analytical testing in accordance with validation
protocols
? Manage group with multiple areas of responsibility and may lead a
component of a project within the job family.
? Identifies and introduces new technology and/or methods to the
organization and trains junior staff.
? Working knowledge of GMPs, pharmacopoeial, regulatory requirements
for analytical testing, phase appropriate standards for method
validation.
? Advanced knowledge of current Good Laboratory Practices (GLPs) and
current Good Manufacturing Practices (GMPs)
Qualifications:
? Competent in the operation of Analytical Instrumentation including
Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower etc.
? Bachelor?s degree or higher in Chemistry or Biology
? Minimum of **Apply on the website** years? relevant experience
? Resilient & dynamic profile with the ability to deliver in an
ambiguous environment
? Ability to engage and manage multiple stakeholders to achieve the
objective
We need : English (Good)
Type: Permanent
Payment:
Category: Others