We are looking for an experienced
HPLC Lead
to oversee the daily operations of our HPLC laboratory ensuring efficient and accurate analysis of multiple product types at various stages of our manufacturing process from raw materials through to finished product testing.
The successful candidate will work on routine day shift but will lead a team of approximately 15 Chemists across a 24 / 7 shift pattern (including weekends). The HPLC Lead will report into the Chemistry Laboratory Manager.
Duties and Responsibilities:
Laboratory Operations
* Supervise and manage the HPLC laboratory, including personnel, equipment, and supplies.
* Develop, implement, and maintain laboratory procedures, protocols, and standard operating procedures (SOPs) for HPLC analysis.
* Ensure compliance with regulatory requirements, industry standards, and company policies.
Analytical Data Quality
* Oversee the analysis of pharmaceutical products, raw materials, and intermediates using HPLC techniques.
* Ensure the accuracy, precision, and reliability of analytical data.
* Develop and implement methods for the analysis of complex samples.
* Collaborate with cross-functional teams to resolve analytical issues and ensure data integrity
Technical Expertise
* Provide technical guidance and support to laboratory personnel on HPLC techniques, instrument operation, and method development.
* Stay up-to-date with the latest advancements in HPLC technology and apply this knowledge to improve laboratory operations and analytical methods.
* Develop and maintain expertise in HPLC software, including data analysis and instrument control.
Regulatory Compliance
* Ensure compliance with regulatory requirements, including FDA, EMA and ICH guidelines.
* Develop and implement procedures for the validation of HPLC methods and instruments.
* Collaborate with regulatory affairs and quality assurance teams to ensure compliance with regulatory requirements.
* Collaborate with various groups on-site (such as QA, Validations, Product Development and Manufacturing teams)
Skills Required :
* Lead, mentor and evaluate both junior and senior HPLC Chemists
* Ensure compliance with Good Laboratory Practices and regulatory requirements
* Maintain laboratory equipment, troubleshoot issues and perform routine maintenance.
* Strong technical knowledge of HPLC instrumentation and method optimisation techniques.
* Strong analytical and problem solving skills
* Strong communication and interpersonal skills
* Ability to work independently and lead a team of qualified Chemists.
* Familiarity with Ph. Eur. And USP requirements along with a strong knowledge of FDA, EMA and ICH guidelines
* Advanced Empower 3 User
What can Vantive offer to you:
* A stable and secure work environment
* A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme
* A collaborative and dynamic work environment
* Access to state-of-the-art equipment and technology
* Recognition and reward for outstanding performance