Method Improvement Specialist

We are recruiting a Method Improvement Specialist who will be responsible for carrying out method re-development and re-validation of all QC methods across all required analytical techniques.

Day-to-day responsibilities

• Plan and develop a method revalidation schedule to ensure current compliance for all QC methods, with specific focus on HPLC methodologies


• Carry out re-development and re-validation activities for legacy QC methods highlighted via the schedule and by the QC team


• Write or review protocols and reports, to support Analytical method Lifecycle management, according to cGXP and specific regulatory requirements (MHRA, EMA, ICH and FDA).


• Support the QC department to reduce the number of LIR's associated to analytical method issues


• Develop and execute protocols for method validation of analytical methods associated with;


• Method transfer from new-products team (NPD)


• Provide expert support and advice to QC batch release Analytical teams to aid in method optimisation, troubleshooting and LIR investigations.


• Coordinate external analytical projects (e.g. Method Validation studies out-sourced to third-party laboratory), review protocols and review progress and reports
  
  We are looking for someone who is fueled by a passion for problem-solving, demonstrating a keenness for investigating detail with an organized and systematic approach. The idea candidate must be comfortable navigating multiple projects and priorities concurrently, they embrace challenge and exhibit a tenacious attitude, refusing to yield in the face of obstacles., BSc Chemistry/Pharmaceutical Sciences or equivalent


• At least 3 years relevant experience conducting method development and validation projects, working with a range of product types and analytical techniques to GMP/GLP standards


• Understanding of process validation, statistical process control/capability or lean and six-sigma techniques


• Understanding of quality risk management


• Significant experience working with HPLC and GC analytical techniques


• A minimum of 3 years experience conducting chromatographic method validation to ICH standards


• Experience working with Pharmacopoeia methodologies, conducting method development: 3 years (required)


• validation project: 3 years (required)


• analytical techniques: 3 years (required)


• GMP: 3 years (required)


• GLP: 3 years (required)
  
  Ethypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine.


Our commitment is to improve patients' lives and make a positive impact on society and the environment.

Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations.

Our six production sites located in France, the UK, Spain, and China have expertise in injectables and complex oral solid forms.

With a global presence in 68 countries, the company markets its products directly in Europe and China, and has strategic partnerships in the EMEA, NA, LATAM and APAC markets.

Ethypharm works closely with the authorities and healthcare professionals to ensure that its medicines are used appropriately and that patients have access to them.


• A competitive salary


• Holiday - 25 days rising to 30 with length of service plus bank holidays


• Holiday Buy/Sell - an opportunity to buy or sell up to an additional 5 days holiday


• 3% Bonus - In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility)


• Bravo Benefits Platform - offering a variety of discounts across well-being and lifestyle


• Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility)


• Medicash health cash plan


• Pension Scheme


• Life Assurance


• Employee recognition scheme


• The opportunity to develop your skills in a collaborative and supportive environment


At Ethypharm we recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business

Job Types: Full-time, Permanent

Pay: £32,000.00-£38,000.00 per year

Benefits:

• Free parking


• Health & wellbeing programme


• On-site parking


• Referral programme


Schedule:

• Monday to Friday


Supplemental pay types:

• Yearly bonus