cGMP Analytical Project Manager/Study Director

Manchester
Posted 1 week ago

Location: Site based in South Manchester

With over 25 years of industry experience my client is a globally respected analytical laboratory which specialises in complex trace analytical chemistry.

Their ultimate mission is to deliver innovative and high-quality analytical expertise to strengthen their clients’ ability to improve product safety and reduce harm to patients and consumers

They partner with customers in the pharmaceutical, biopharmaceutical, medical device, and consumer sectors to ensure their products are safe and compliant with pertinent regulations.

The requirements of cGMP Analytical Project Manager:

  • You will already have a proven track record (3+ years) of managing studies conducted in cGMP and/or GLP environments involving GC-MS and LC-MS analysis
  • Educated in a chemistry degree (or equivalent) and/or significant experience in directing quantitative and qualitative analytical studies of complex samples
  • Previous experience of working to cGMP or GLP is a must
  • PC literate in Microsoft packages (Word, Excel, PowerPoint etc.)
  • Very strong analytical skills with proven ability to break down and solve problems in a logical and structured approach
  • Strong relationship management and excellent communication skills/influencing skills

The responsibilities of the cGMP Analytical Project Manager:

  • Providing Study Direction in accordance with applicable regulatory requirements (cGMP, GLP or ISO17025)
  • Liaising with subject matter experts to draft study plans in line with client requirements
  • Responsibility for the overall conduct of studies
  • Understanding responsibilities of Study Personnel specified under cGMP & GLP regulations
  • Liaising with internal and external customers to ensure prompt and proper action on all aspects of the study plans for studies assigned
  • Attending and, where appropriate, assisting in key elements of the work of assigned studies including monitoring progress and status
  • Leading and participating in study-specific client visits as required
  • Coordinate the execution of studies with laboratory managers and personnel
  • Verify that studies are performed, documented, and completed according to customer expectations and quality system requirements
  • Participation at professional conferences and presentations/meetings at customer sites as needed
  • Write or review controlled procedures including SOPs, Process Instructions, Test Methods, and material specifications.
  • Assist in delivering continuous improvement projects relating to, but not limited to, study design and conduct, as required
  • Compliance with relevant regulatory standards (cGMP, GLP & ISO17025)
  • Compliance with all Company requirements in relation to Health and Safety
  • Effective communication with team member with a collaborative approach across departments
  • Help to build a culture that drives employee engagement, creating an enjoyable place to work

Benefits:

  • Base Salary Circa £35,000 – £42,000 (DOE)
  • Bonus (Quarterly paid)
  • Pension (8% Employer Contribution)
  • Westfield Medical Cash Plan
  • Life Insurance (4X Base Salary)
  • 25 Days Holidays + Statutory Public Holidays
  • Free Parking Onsite

Apply right now by calling Oliver Gill – Specialist Recruitment Consultant at Langton Howarth Ltd on + 44 (0) 113 243 3499 and email your up to date word CV to olivergill@langtonhowarth.com Langton Howarth is the market leading scientific supplies company placing people into dream jobs across the UK and Europe daily.

To be considered for this role you must have the right to work in the UK.

Langton Howarth also operates a recommend a friend referral scheme. So, if you know someone who could be good for this job, email your nominated candidate’s name and contact details in confidence via email too, and we will ensure you receive £100.00 of vouchers from a high street retailer of your choice!

Job Features

Job CategoryLaboratory

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