A fantastic contract opportunity has arisen for an experienced Process Development Scientist who specialises in analytical method troubleshooting, development and validation to support process development and qualification within a leading Biopharmaceutical company. This is not a routine sample testing role this is a role centred around troubleshooting and over coming challenges associated with analytical method development and qualification within the lab.
This is an on-site Laboratory based role with responsibility for Analytical Support activities involving:
- Analytical Method Troubleshooting,
- Analytical Method Lifecycle (Development, Qualification, Validation, Remediation)
- Analytical support for Process Development and Qualification activities at the site and wider network
The successful candidate will have proven analytical experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have excellent communication skills and be focussed on delivering on our customer needs. The successful candidate will also have a strong understanding of Data Integrity principles, Quality and Compliance in the laboratory as well as good presentation/influencing skills. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.
Key Responsibilities:
- Analytical method troubleshooting, qualification, validation, bridging, transfer etc.
- Analytical support for Process Development and Process Qualification activities
- Act as support for the Attribute Sciences function on cross functional teams/programs
- Timely documentation of Analytical data in the electronic notebook system.
- Understanding of data flow in laboratory systems and data integrity.
- Participate in the peer review of analytical data.
- Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory
- Ensure the laboratory is operated in a safe and environmentally friendly manner.
- Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.
- Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.
- Ensure timely completion of Laboratory Investigations, Deviations , PMAFs
- Participate in internal/external audits/inspections as required.
- Plan and implement procedures and systems to maximise operating efficiency.
- Manage and contribute to the achievements of department productivity and goals.
- Engage with the Continuous Improvement Process and MyGreenLab® philosophy.
Qualifications:
- Hold , at a minimum a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.
- Have 3-6 years of relevant analytical experience in the Pharmaceutical Industry
- HPLC experience is a must and the candidate must be able to demonstrate troubleshooting abilities that would fall under the design of experiment, troubleshooting, hypothesis testing, etc.
- Empower CDS at a power-user/advanced user level desired.
Knowledge and Experience:
- Subject Matter Expert for General and Compendial methods used in the analysis of Drug Product such as Sub Visible Particle Analysis, KF Moisture, Ph, Osmolality, Density, App/Colour/Clarity, CCI, Breakloose and Extrusion, RAMAN, FTIR, NIR, UV/VIS Spectrophotometry, SEM
- Experience with Chromatographic methods such as HPLC, UPLC, with UV, RID, Mass Spec detection would also be favourable but not essential.
- Excellent written and verbal communication skills
- Science based decision maker.
- Experience with Regulatory inspections and interaction with inspectors is preferable.
- Experience working with teams and influencing decisions.
- Skilled in the use of problem-solving tools/techniques
- Experience with developing, validating, troubleshooting, analytical methods
- Understanding of Process Validation activities (Engineering, PPQ, Comparability/Characterisation studies).
- Understanding of the Change Control and Variation Management Process
- Understanding how the use of statistical tools, such as multivariate analysis can aid troubleshooting.
- Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
