Skip to main content

This job has expired

Analytical Validation Specialist

Employer
Hobson Prior
Location
London, England
Salary
GBP40000 - GBP44000 per annum
Start date
21 Sep 2021
Closing date
21 Oct 2021

View more

Discipline
Manufacturing, Validation
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Hobson Prior are seeking for an Analytical Validation Specialist to join a Biotech organisation to be located in London on a permanent basis. Our client are determined to develop treatments who can save patients' lives.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

  • Produce method SOPs are developed and executed to support all validated methods.
  • Partner with validation, QC, QA, and R&D team as well as with external partners to support internal and external project timelines.
  • The development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
  • Create validation test protocols and reports in support of the tech transfer and validation activities performed ensuring compliance requirements are maintained.
  • Support the setup of the QC department for the continuation of the clinical trial material, commercial supply, and stability studies.
  • Confirm appropriate communication to method transfer progress and plan adherence.
  • Maintain the flow of information to key stakeholders, ensure appropriate communications are passed forward and information folders are maintained with most recent versions/communications.
  • Ensure the development and rollout of training on new technology/methodology.
  • Complete routine assessment of the analytical methods used to assure they are being applied and are operating as expected.
  • Confirm all methods are validated and transferred to QC GMP labs in compliance with regulatory standards and adhere to data integrity requirements.
  • Confirm all training is commenced in a timely manner as required to perform required activities. Support any training activities of other employees where required.
  • Support with continuing with QMS and controlling of documents and ensuring the data integrity of all data produced.
  • Ensure own work complies with GMP, Data Integrity, and Good Documentation Practice and is undertaken in accordance with applicable quality documents e.g. SOP's, Protocols, Guidance's, etc.
  • Ensure own training is completed in a timely and GMP compliant manner before the task is undertaken.
  • Confirm own KPI's, plans, targets, and objectives are effectively tracked, monitored, and achieved in agreement with timelines.

Requirements:

  • Educated in a MSc in Biosciences or Biochemistry with equivalent relevant work experience in the pharmaceutical or other similar regulated industry.
  • Previous experience in an analytical development and validation role in the pharmaceutical industry with a strong research background.
  • Previous experienced with analytical techniques, example, qPCR, HPLC, ELISA, SDS, cell-culture and DNA extraction, including method development and troubleshooting.
  • Expertise in a body of information required for the job e.g knowledge of EU and FDA regulations, ICH guidelines, GMP/GLC/GCP, etc.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert