The Analytical Development Chemist will function as a key member of
the Analytical Development Team. You?ll be responsible for providing
analytical expertise and technical support for all phases of drug
development. This will include high quality analytical and technical
support to internal and external customers, to ensure that analytical
infrastructure is in place to support the introduction of new products
and support development activities.
To promote and monitor laboratory GMP / Safety within the Analytical
Development (AD) group such that the AD laboratory is maintained as an
inspection ready facility. To actively participate in the development
of the AD group as a centre of excellence.
What will you do? Provide analytical expertise and analytical support
for the introduction of new products to the Cork site, including
method development, validation/qualification and transfer of methods
to clients as required. Support innovative development of new
analytical methods as well as improvement and optimisation of current
methods.
Lead in troubleshooting analytical technical challenges during the
development, validation/qualification and transfer of methods. Plan,
execute and evaluate fate of impurities studies in collaboration with
colleagues and client through interpretation of analytical data and
adhering to current and emerging regulatory strategies (quality by
design, GMP, ICH?s guidelines) for API.
Provide lead analytical support to development projects in the
laboratory by supporting route scouting, route development, proof of
concept and process proven acceptable range studies.
Responsible for the day-to-day activities and guidance of their team
members.
Complete analytical data collection, interpretation and
characterization of compounds while ensuring proper documentation of
experimental data is adhered to.
Preparation, review and approval of change controls, study protocols,
project status report, final reports and other internal documentation
relevant to the role.
Communicate regularly with the clients, providing updates on projects
progress, hosting clients visits, addressing technical queries and
delivering client project requirements to the defined timelines.
Develop/Expand scientific, technical knowledge by reading the peer
reviewed scientific literature, attending scientific conferences and
via relevant training.
Ensure the delivery of projects in the required timeframe and ensure
that the site?s technical, quality and safety metrics are all
achieved.
Work with due care and attention, perform all quality, regulatory and
safety duties in a compliant manner whilst acting always in accordance
with the Dignity at Work Policy, Code of Business Conduct and Ethics
and our values of Integrity, Intensity, Innovation and Involvement.
Create, update analytical methods and specifications as appropriate.
Prepare QC handover package. Present training sessions to QC as agreed
with QC and provide technical support during method familiarisation
period.
Provide bench and technical support to the validation campaign.
In conjunction with the Stability Process Owner, set down validation
batches on stability and provide support to stability testing as
defined in the stability protocol.
Support external audits as appropriate.
Who we are looking for: (input experience, skills & abilities)
Relevant qualification such as BSc;
Masters or PhD in relevant scientific discipline with significant
experience in industry or academia.
Experience in analytical method development, validation and analytical
technology transfer.
The candidate should be a subject matter expert with HPLC, UHPLC, GC,
LC/MS, GC/Headspace, GC/MS, UV, IR, KF, ion chromatography, ICPAn up
to date knowledge of Quality guidelines e.g. ICH, FDA, EMA and
GMPEmpower experience.
Knowledge and experience within a pharmaceutical manufacturing and
chemical development environment and experience in analytical
technology transfer is desirable.
Demonstrated core laboratory skills and expertise in various wet
chemistry and analytical techniques such as spectroscopy and
chromatography techniques, with an excellent understanding of the
relevance of the data generated.
Proficient knowledge in performing validations, qualifications,
transfers and development of new analytical methods in accordance to
ICH guidelines.
Demonstrated ability to think critically and innovatively combined
with willingness to challenge.
The candidate will have great organizational skills and proven ability
of troubleshooting to rapidly respond to technical challenges.
Excellent technical writing skills and oral communication are required
to interact with all level of organization and clients.
_ABILITY TO_ work with cross functional teams with collaborative
communication skills to engage with employees and clients at all
levels.
What?s in it for you:
Competitive base salary
Annual bonus
Free on-site car parking
Contributory Pension
Private medical insurance
_ABOUT US_ :
Thermo Fisher Scientific Inc. is the world leader in serving science,
with annual revenue exceeding $**Apply on the website** billion. Our
Mission is to enable our customers to make the world healthier,
cleaner and safer. Whether our customers are accelerating life
sciences research, solving complex analytical challenges, improving
patient diagnostics and therapies or increasing productivity in their
laboratories, we are here to support them.
Our global team of more than **Apply on the website**,**Apply on the
website** colleagues delivers an unrivaled combination of innovative
technologies, purchasing convenience and pharmaceutical services
through our industry-leading brands, including Thermo Scientific,
Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services
and Patheon
With Thermo Fisher Scientic, it?s not just a career. It?s a chance
to realise your best ? professionally and personally.
Apply today! The job:
The Analytical Development Chemist will function as a key member of
the Analytical Development Team. You?ll be responsible for providing
analytical expertise and technical support for all phases of drug
development. This will include high quality analytical and technical
support to internal and external customers, to ensure that analytical
infrastructure is in place to support the introduction of new products
and support development activities.
To promote and monitor laboratory GMP / Safety within the Analytical
Development (AD) group such that the AD laboratory is maintained as an
inspection ready facility. To actively participate in the development
of the AD group as a centre of excellence.
What will you do? Provide analytical expertise and analytical support
for the introduction of new products to the Cork site, including
method development, validation/qualification and transfer of methods
to clients as required. Support innovative development of new
analytical methods as well as improvement and optimisation of current
methods.
Lead in troubleshooting analytical technical challenges during the
development, validation/qualification and transfer of methods. Plan,
execute and evaluate fate of impurities studies in collaboration with
colleagues and client through interpretation of analytical data and
adhering to current and emerging regulatory strategies (quality by
design, GMP, ICH?s guidelines) for API.
Provide lead analytical support to development projects in the
laboratory by supporting route scouting, route development, proof of
concept and process proven acceptable range studies.
Responsible for the day-to-day activities and guidance of their team
members.
Complete analytical data collection, interpretation and
characterization of compounds while ensuring proper documentation of
experimental data is adhered to.
Preparation, review and approval of change controls, study protocols,
project status report, final reports and other internal documentation
relevant to the role.
Communicate regularly with the clients, providing updates on projects
progress, hosting clients visits, addressing technical queries and
delivering client project requirements to the defined timelines.
Develop/Expand scientific, technical knowledge by reading the peer
reviewed scientific literature, attending scientific conferences and
via relevant training.
Ensure the delivery of projects in the required timeframe and ensure
that the site?s technical, quality and safety metrics are all
achieved.
Work with due care and attention, perform all quality, regulatory and
safety duties in a compliant manner whilst acting always in accordance
with the Dignity at Work Policy, Code of Business Conduct and Ethics
and our values of Integrity, Intensity, Innovation and Involvement.
Create, update analytical methods and specifications as appropriate.
Prepare QC handover package. Present training sessions to QC as agreed
with QC and provide technical support during method familiarisation
period.
Provide bench and technical support to the validation campaign.
In conjunction with the Stability Process Owner, set down validation
batches on stability and provide support to stability testing as
defined in the stability protocol.
Support external audits as appropriate.
Who we are looking for: (input experience, skills & abilities)
Relevant qualification such as BSc;
Masters or PhD in relevant scientific discipline with significant
experience in industry or academia.
Experience in analytical method development, validation and analytical
technology transfer.
The candidate should be a subject matter expert with HPLC, UHPLC, GC,
LC/MS, GC/Headspace, GC/MS, UV, IR, KF, ion chromatography, ICPAn up
to date knowledge of Quality guidelines e.g. ICH, FDA, EMA and
GMPEmpower experience.
Knowledge and experience within a pharmaceutical manufacturing and
chemical development environment and experience in analytical
technology transfer is desirable.
Demonstrated core laboratory skills and expertise in various wet
chemistry and analytical techniques such as spectroscopy and
chromatography techniques, with an excellent understanding of the
relevance of the data generated.
Proficient knowledge in performing validations, qualifications,
transfers and development of new analytical methods in accordance to
ICH guidelines.
Demonstrated ability to think critically and innovatively combined
with willingness to challenge.
The candidate will have great organizational skills and proven ability
of troubleshooting to rapidly respond to technical challenges.
Excellent technical writing skills and oral communication are required
to interact with all level of organization and clients.
_ABILITY TO_ work with cross functional teams with collaborative
communication skills to engage with employees and clients at all
levels.
What?s in it for you:
Competitive base salary
Annual bonus
Free on-site car parking
Contributory Pension
Private medical insurance
_ABOUT US_ :
Thermo Fisher Scientific Inc. is the world leader in serving science,
with annual revenue exceeding $**Apply on the website** billion. Our
Mission is to enable our customers to make the world healthier,
cleaner and safer. Whether our customers are accelerating life
sciences research, solving complex analytical challenges, improving
patient diagnostics and therapies or increasing productivity in their
laboratories, we are here to support them.
Our global team of more than **Apply on the website**,**Apply on the
website** colleagues delivers an unrivaled combination of innovative
technologies, purchasing convenience and pharmaceutical services
through our industry-leading brands, including Thermo Scientific,
Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services
and Patheon
With Thermo Fisher Scientic, it?s not just a career. It?s a chance
to realise your best ? professionally and personally.
Apply today!
We need : English (Good)
Type: Permanent
Payment:
Category: Others
