About this role
Background:
The Technical Services team is seeking an experienced Scientist to support the commercial production of Drug Substance batches from the suite 1 and suite 2 manufacturing facilities.
The successful candidate will work collaboratively with the broader Technical Services Teams to provide technical services that align with site business objectives. The role involves transitioning efficiently between projects and/or managing multiple smaller projects at the same time. This position reports to the Technical Services manager for the suite 1 and suite 2 sustaining team and is part of the site technical services group.
Job Responsibilities included but not limited to:
- Supporting the Operational Unit to ensure alignment with the plan of record. This encompasses supporting investigations, enhancing process robustness, and driving projects focused on process and yield improvements.
- The review, assessment and approval of supplier change notifications (SCNs). Responsibilities may include preparing, reviewing, and executing protocols, as well as authoring supporting documentation for changes resulting from the SCNs.
- Supporting the introduction of new or alternate raw materials or consumables.
- Authoring/ reviewing sections of regulatory dossiers including health authority query responses
- Authoring/reviewing the annual continued verification reports for the product in the manufacturing in suite 1&2.
- Authoring / reviewing specific sections of the Annual product review report.
- Supporting regulatory inspections.
- Developing and maintaining effective working relationships with other departments such as Operations, QA, QC, QPs, regulatory, supply chain and MSAT as well global teams.
Education and skills:
- Third level qualification in Science, Engineering or equivalent.
- Minimum of 3 Years cGMP industrial experience within bioprocess manufacturing sector.
- Strong knowledge of downstream drug substance manufacturing preferred
- High technical capability for interpret complex data, problem solving and technical learning
- Strong technical writing skills a must.
- Capability of working in a multi-disciplinary team environment to tight timelines
- Effective communication, planning and organisation skills to deliver documentation on time.
Work Location Assignment: Hybrid
Additional Information
In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
Please note there is no relocation support available for this position
How to apply
Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Other facts
About Pfizer
We’re celebrating over 175 years of daring scientific innovation—and we’re not done yet. Let’s outdo yesterday. Protect your health at PfizerForAll.com
For additional information on our guidelines, please visit http://www.pfizer.com/community-guidelines
What you'll do
- The Scientist will support the commercial production of Drug Substance batches and work collaboratively with Technical Services Teams to align with business objectives. Responsibilities include supporting investigations, enhancing process robustness, and managing multiple projects simultaneously.
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