Analytical Chemist

Job description

Orion Group Life Sciences are currently recruiting an Analytical Chemist on behalf of our Multinational Biopharmaceutical Client based in Tipperary until end of December 2024 with strong potential to extend.

To execute and appropriately document testing of Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols. To provide analytical support to product quality investigations including the use of sophisticated analytical techniques. To undertake significant assignments and to work on own initiative and with minimum supervision e.g. technology transfer for new product demonstrations; new methods development; management of an on-going programme such as the Intermediate Stability programme; and to provide training for other chemists and other lab staff.

Responsibilities

The Laboratory Analyst has responsibility for Raw Material, Intermediate, Drug Substance & Drug Product testing to meet compliance requirements and customer targets. The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level.
The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP.
The Laboratory Analyst assures compliance with all safety and environmental requirements.
Compliance with other regulated areas such as HR policies are also responsibilities of the role.
To test Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols.
To comply with all GMP and analytical procedures relevant to area of work.
To adhere and comply with department High Performance Analytical Behaviours
To document all testing activities and to input results into computerised lab systems in accordance with department and MMD standards.
To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
Complete the investigation of laboratory OOSs (Z1 Quality Notifications), in line with site and
divisional procedures and Provide leadership in the laboratory aspects of OOS investigations.
Complete documentation checks (e.g. GCM's, Quality Notifications, Data Integrity) as required for test packages prior to release.
To complete testing as required on non-routine samples to support process changes, Request for Service, Quality Notifications.
Accountable for own laboratory safety practices. Follow the principles of Safe by Choice
To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
To identify and aid resolution of analytical issues within the IPT laboratory.
To be a resource for analytical testing for the site as required.
Execute specific assignments (e.g. DI Initiatives, Lab X Champion, Empower/LIMS Superuser and other systems) in a comprehensive manner and under minimum supervision.
Complete training with new laboratory Analysts and Laboratory Apprentices.

Qualifications, Skill & Experience

Technical:

To have demonstrated knowledge of MMD and site quality policies, procedures and guidelines which relate to finished product testing and release.
Relevant GMP standards
Lab safety standards

Business:

To perform analytical testing with a high degree of precision and accuracy
To perform instrument maintenance and troubleshooting
To maintain accurate records in compliance with ALCOA principles and GMP expectations
To understand and internalise procedures relevant to GMP operations
To communicate clearly and concisely on technical issues
On assignment, to manage specific department projects
To provide training programmes to laboratory staff as assigned
To liaise effectively with external groups such as MRL, RAS, DI COE, etc.
To act as auditee (in internal and external audits) for assigned areas of responsibility

Leadership:

Analytical chemistry - demonstrated ability in all technical elements relevant to ADC
IPT operation
Technical lab skills (precision, etc)
Strong aptitude for handling analytical instruments
Clear understanding of DI requirements
Mechanical and computer
Communication - written, oral
Team and interpersonal skills
Leadership skills
Orion Group Life Sciences are currently recruiting an Analytical Chemist on behalf of our Multinational Biopharmaceutical Client based in Tipperary until end of December 2024 with strong potential to extend.
To execute and appropriately document testing of Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols. To provide analytical support to product quality investigations including the use of sophisticated analytical techniques. To undertake significant assignments and to work on own initiative and with minimum supervision e.g. technology transfer for new product demonstrations; new methods development; management of an on-going programme such as the Intermediate Stability programme; and to provide training for other chemists and other lab staff.
Responsibilities
- The Laboratory Analyst has responsibility for Raw Material, Intermediate, Drug Substance & Drug Product testing to meet compliance requirements and customer targets. The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level.
- The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP.
- The Laboratory Analyst assures compliance with all safety and environmental requirements.
- Compliance with other regulated areas such as HR policies are also responsibilities of the role.
- To test Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols.
- To comply with all GMP and analytical procedures relevant to area of work.
- To adhere and comply with department High Performance Analytical Behaviours
- To document all testing activities and to input results into computerised lab systems in accordance with department and MMD standards.
- To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
- Complete the investigation of laboratory OOSs (Z1 Quality Notifications), in line with site and
- divisional procedures and Provide leadership in the laboratory aspects of OOS investigations.
- Complete documentation checks (e.g. GCM's, Quality Notifications, Data Integrity) as required for test packages prior to release.
- To complete testing as required on non-routine samples to support process changes, Request for Service, Quality Notifications.
- Accountable for own laboratory safety practices. Follow the principles of Safe by Choice
- To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
- To identify and aid resolution of analytical issues within the IPT laboratory.
- To be a resource for analytical testing for the site as required.
- Execute specific assignments (e.g. DI Initiatives, Lab X Champion, Empower/LIMS Superuser and other systems) in a comprehensive manner and under minimum supervision.
- Complete training with new laboratory Analysts and Laboratory Apprentices.
Qualifications, Skill & Experience
Technical:
- To have demonstrated knowledge of MMD and site quality policies, procedures and guidelines which relate to finished product testing and release.
- Relevant GMP standards
- Lab safety standards
Business:
- To perform analytical testing with a high degree of precision and accuracy
- To perform instrument maintenance and troubleshooting
- To maintain accurate records in compliance with ALCOA principles and GMP expectations
- To understand and internalise procedures relevant to GMP operations
- To communicate clearly and concisely on technical issues
- On assignment, to manage specific department projects
- To provide training programmes to laboratory staff as assigned
- To liaise effectively with external groups such as MRL, RAS, DI COE, etc.
- To act as auditee (in internal and external audits) for assigned areas of responsibility
Leadership:
- Analytical chemistry - demonstrated ability in all technical elements relevant to ADC
- IPT operation
- Technical lab skills (precision, etc)
- Strong aptitude for handling analytical instruments
- Clear understanding of DI requirements
- Mechanical and computer
- Communication - written, oral
- Team and interpersonal skills
- Leadership skills

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.