Job summary
The post holder will be required to work under the direction of The Head of R&D and Senior Development Scientists at HPS. The post holder will primarily perform stability analysis and initiate and manage stability studies. The post holder will follow work programs, carry out experimental work, generate and complete development protocols and reports in accordance with the principles of current Good Manufacturing Practice (cGMP) and Good Control Laboratory Practice (GCLP). The post holder will work closely with team members and be responsible for stability testing of new products, providing project support, development projects, the development of analytical methods and validation of methods for use in QC and also contribute to resolving product formulation issues and challenges.
Main duties of the job
Main Tasks
New Product Development
o Initiate and manage stability studies (as per ICH) for New Products in order to assign Shelf Life.
o Analyse prototype and stability samples as required and report results in a timely manner.
o Maintain and monitor stability chambers, including the monitoring of sample pull dates.
o Develop and formulate new pharmaceutical formulations following Quality by Design Principles.
o Lead and assist in formulation development studies.
o Assist development team members on internal and external projects.
o Develop appropriate, robust methods for the analysis of new pharmaceutical formulations.
o Ensure all development activities are in line with departmental procedures.
o Perform analysis of all validation batches
o Liaise with the Formulation Pharmacist to generate new product specifications
About us
CHFT is an integrated Trust of 6,500+ colleagues providing hospital and community services to patients and communities across Calderdale and Kirklees. We are rated as 'Good' by the Care Quality Commission, are a top performing Trust for Elective Recovery, Emergency and Cancer Care and widely acknowledged as a national digital lead when it comes to caring for people across our local and regional systems.
Our people are at the core of everything we do, hence our commitment to One Culture of Care. Our focus is to care for and support each other in order to provide outstanding compassionate care to our patients. That is why we are looking for an inclusive collaborative, creative, innovative and compassionate leader to join us in this role.
Job description
Job responsibilities
Analytical Duties
Routine stability analysis.
Write and execute stability protocols and studies.
Write and execute validation protocols and reports for transfer to QC, in compliance with ICH expectations.
Liaise with QC staff to ensure effective technology transfer of new products into routine analysis.
Assists with the completion of corrective and preventative actions arising from Quality Incidents within agreed time frames.
Complies with Health and Safety and COSHH regulations within the section.
Identify future equipment needs for the continuing development of HPS capabilities in analytical development
Ensures all testing undertaken is performed in accordance with laboratory specifications and standard operating procedures.
Use Quality by Design principles in the design of new methods.
Participate in the Personal Development Review Program.
Perform Dissolution Testing of prototype formulations as part of product development
Job description
Job responsibilities
Analytical Duties
Routine stability analysis.
Write and execute stability protocols and studies.
Write and execute validation protocols and reports for transfer to QC, in compliance with ICH expectations.
Liaise with QC staff to ensure effective technology transfer of new products into routine analysis.
Assists with the completion of corrective and preventative actions arising from Quality Incidents within agreed time frames.
Complies with Health and Safety and COSHH regulations within the section.
Identify future equipment needs for the continuing development of HPS capabilities in analytical development
Ensures all testing undertaken is performed in accordance with laboratory specifications and standard operating procedures.
Use Quality by Design principles in the design of new methods.
Participate in the Personal Development Review Program.
Perform Dissolution Testing of prototype formulations as part of product development
Person Specification
QUALIFICATIONS / TRAINING
Essential
- Degree in Chemistry, Pharmaceutical Sciences or equivalent scientific qualification
Desirable
- Masters in Chemistry or other appropriate scientific discipline
- Relevant analytical training (i.e. HPLC, method development, stability training courses etc)
KNOWLEDGE, EXPERIENCE & EXPERTISE
Essential
- Experience in performing QC/stability routine analysis of pharmaceutical formulations by HPLC in commercial laboratory
- Experience of using Chromeleon (or other chromatography software).
- Sample extraction techniques for a wide variety of dosage forms
- Use of lab instruments such as HPLC, GC, UV, FTIR, Karl Fischer, Viscometer, Osmometer.
- Experience of creation of analytical specification in compliance with pharmacopeial/ICH requirement
- Experience of documenting and following in-house procedures with out of trend/specification results
Desirable
- Experience in writing development and stability reports
- Analytical method validation experience to ICH guidelines.
- Knowledge of Clinical Trials and medical devices.
- Experience in analytical method development of stability indicating methods; HPLC, GC (>2 years)
- Knowledge of regulatory requirements for licensed products
- Experience in formulating pharmaceutical solutions
- Analytical skills to identify and report trending of stability data
- Raw materials analysis
COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)
Essential
- Excellent communication in various forms (oral, written, digital) and maintain the ability to work as part of a team
- Enthusiastic, motivated and hard working
- Organised, tidy and methodical
- Ability to work to GMP and maintain data integrity
- Able to understand and follow written procedures
Person Specification
QUALIFICATIONS / TRAINING
Essential
- Degree in Chemistry, Pharmaceutical Sciences or equivalent scientific qualification
Desirable
- Masters in Chemistry or other appropriate scientific discipline
- Relevant analytical training (i.e. HPLC, method development, stability training courses etc)
KNOWLEDGE, EXPERIENCE & EXPERTISE
Essential
- Experience in performing QC/stability routine analysis of pharmaceutical formulations by HPLC in commercial laboratory
- Experience of using Chromeleon (or other chromatography software).
- Sample extraction techniques for a wide variety of dosage forms
- Use of lab instruments such as HPLC, GC, UV, FTIR, Karl Fischer, Viscometer, Osmometer.
- Experience of creation of analytical specification in compliance with pharmacopeial/ICH requirement
- Experience of documenting and following in-house procedures with out of trend/specification results
Desirable
- Experience in writing development and stability reports
- Analytical method validation experience to ICH guidelines.
- Knowledge of Clinical Trials and medical devices.
- Experience in analytical method development of stability indicating methods; HPLC, GC (>2 years)
- Knowledge of regulatory requirements for licensed products
- Experience in formulating pharmaceutical solutions
- Analytical skills to identify and report trending of stability data
- Raw materials analysis
COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)
Essential
- Excellent communication in various forms (oral, written, digital) and maintain the ability to work as part of a team
- Enthusiastic, motivated and hard working
- Organised, tidy and methodical
- Ability to work to GMP and maintain data integrity
- Able to understand and follow written procedures
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Calderdale and Huddersfield NHS Foundation Trust
Address
Calderdale & Huddersfield NHS Foundation Trust trading as "Huddersfield Pharmacy Specials"
Gate 2 Acre Mill, School Street West
Huddersfield
HD3 3ET
Employer's website
https://www.cht.nhs.uk (Opens in a new tab)
