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Tech Transfer Lead

Employer
i-Pharm Consulting
Location
Dún Laoghaire, Republic of Ireland, Dublin
Salary
EUR42 - EUR47 per hour
Start date
1 Jun 2023
Closing date
26 Jun 2023

View more

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

Job Details

Title: Tech Transfer Lead

Contract Length: 12 Months

Pay rate: €42 - €47/hour + 35% shift allowance (when applicable)

Work Schedule: Monday to Friday, 37.5H/W

Location: Dun Laoghaire, Co.Dublin, Ireland

Role Overview:

Our client is looking for a Tech Transfer Lead to provide process development support to new product introductions (NPI) and life-cycle changes to site, provide subject matter expertise for unit operations and support ongoing production. The successful candidate will provide technical support to large molecule and small molecule drug product manufacturing at their bio-pharmaceuticals site, as well as part of the global Process Development (PD) organisation. You will also have the opportunity to be directly involved in 2 major projects that are currently in qualification phase.

24/7 shift pattern is not mandatory but may be required once or twice a year for one to two weeks at time 35% shift rate applies.

Some of the key responsibilities for the Tech Transfer Lead will include:

  • Leads new product introductions and life-cycle changes into Vial filling and Syringe filling from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer
  • Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required
  • Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
  • Provide process development expertise for commercial drug product processing in specific areas
  • Develops and characterises drug product processes and transfers technology to commercial drug product sites.

Basic Qualifications:

  • A third level Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience
  • Knowledge of cGMPs and other worldwide regulatory requirements.
  • Problem solving ability and excellent oral and written communications skills

Preferred Qualifications:

  • PhD or Masters in Science or Engineering
    5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterisation, Tech Transfer (to commercial DP sites) or Validation.
  • Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry regarding chemical and physical stability
  • Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
    Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
  • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill is essential for this role.

Does this sound like you? If so, please apply today!

Get in touch to discuss this role!

My number is 020 7 551 0727

jkirlew@i-pharmconsulting.com

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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