Tech Transfer Lead

2 weeks ago

Dublin, Ireland PSC Biotech Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 5+ years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Job Title: Tech Transfer Lead

This role will require the candidate to provide processdevelopment support to new product introductions (NPI) and lifecycle changes tosite, provide subject matter expertise for unit operations and support ongoingproduction. The candidate will provide technical support to large molecule andsmall molecule drug product manufacturing at client site as well as part of theglobal Process Development (PD) organization. Client is currently operatingwith one RABS vial filling machine and one Syringe filling machine. Two majorprojects are ongoing, one: to introduce an Isolator Vial Fill Line which is nowin its qualification phase and two: the significant increase in output volumefrom the Syringe Fill Line. Successful applicants will be directly involved inthese projects.

Requirements

The input provided will also include support of processperformance and implementation of process improvement strategies and willinclude the following:

· Leads new product introductions and lifecyclechanges into Vial filling and Syringe filling from a Process Developmentperspective and then serves as the Process Development SME for these productsfollowing completion of the transfer.

· Be a key contributor to regulatory filings aspart of the NPI process throughout the authoring, editing and submissionprocess but also be responsible for response to regulator questions as and whenrequired.

· Acts as a drug product manufacturing technicalexpert to provide solutions when troubleshooting drug substancefreezing/thawing, formulation, filling vials/syringes/devices, lyophilization,inspection, and transportation for parenteral products through the NPI orpost-NPI phases.

· Provide process development expertise forcommercial drug product processing in specific areas such as sterileprocessing, process characterization, tech transfer and validation. Supportcommercial drug product manufacturing operations with technical evaluation ofNC/CAPA and technology transfer. Interfaces with manufacturing as well as allsupport functions to provide robust and coordinated support to manufacturing.

· Develops and characterizes drug productprocesses and transfers technology to commercial drug product sites.

· Identifies and implements operationalopportunities for current and new sterile operations.

· Troubleshoots issues with drug productprocessing technologies and equipment.

· Leads and conducts risk assessment for drugproduct operations and propose / implement appropriate CAPA.

· Responsibilities may include leading cross-siteteams to support the above activities, providing recommendations to management.

· Development and execution of validation plans,process performance qualifications (PPQs) for vial and syringe filling with across functional team.

· Ensuring all aspects of activity within anygiven process validation adheres to required policies and procedures, includingsafety and training.

· Ensure that the site meets the qualityrequirements of its customers and applicable regulations (FDA, EU &international standards).

· Assist in the development of any existingvalidation program to ensure continued compliance to the necessary regulations.

· Pre-approve and post-approve process validationprotocols and assessments from a quality system documentation perspective.

· Contribute to product quality assessments andprocess flow documents.

· Liaise with Operations, Engineering and externalvendors regarding new or amended equipment which would impact the validatedproduct.

· Lead or assist in deviation and exceptionresolution and root cause analysis.

· Participate as required in project activitiesand be developing own project management techniques.

Basic Qualifications:

· A third level bachelor’s degree in science,Engineering or a relevant Quality discipline with 5 years’ experience in asimilar role OR Master’s degree & 3 years of directly related experience ORassociate degree & 10 years of directly related experience

· Knowledge of cGMPs and other worldwideregulatory requirements.

· Problem solving ability and excellent oral andwritten communications skills.

Preferred Qualifications:

· PhD or master’s in science or engineering

· 5 + years of experience in support of CommercialProtein Drug Product (DP) processing in specific areas such as SterileProcessing, Process Characterization, Tech Transfer (to commercial DP sites) orValidation.

· Strong skills in applying fundamentalengineering and scientific principles to the design, implementation and processvalidation of protein freeze-thawing, filtration, mixing, filling, and/orlyophilization processes. Knowledge of protein biochemistry regarding chemicaland physical stability

· Project management skills including the abilityto manage multiple projects and evaluate project resource requirements.

· Strong knowledge of Quality systems, DrugProduct Manufacturing and Validation.

· Demonstrated ability in providing leadership tocross-functional teams to advance complex projects to completion. ExcellentCommunication skill is essential for this role.

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