Compendial Compliance Specialist

Compendial Compliance Specialist

Location: Cork, Ireland (onsite/hybrid/remote working available)

Duration: 12 months 

Hours: 39

Pay rate range: Depending on experience

Imagine your next project where you will be working within the Compendial Compliance Team which sits within the Physico-chemical Sciences and Sample Management team as part of the wider BTDS AD Department. 

roles and responsibilities

The department is responsible for Clinical Release and Stability Testing for Drug Substance and Drug Product, and Stability Lifecycle management

This will involve: 

• Act as a Large Molecule, Subject Matter Expert (SME) solely responsible for ownership of compendial and particulate methods in maintaining applicable regional compliance. The scope of the methods encompasses methods such as - pH, Color, Turbidity, Osmolality, Turbidity, Moisture, Extractable Volume, Visible Appearance, Sub-Visible Particulates and MDI, etc.

• Independently write/revise SOP’s or other official documentation and reports, when required.

• Keep up to date with existing and new SOP’s and official documentation.

• Ability to author the Product Regulatory Section Submissions/Responses to support IND/BLA Filings, as required.

• Lead/deliver the clinical product lifecycle management from Phase I-III with regards to product presentation and formulation changes and manage the coordination of the demonstration of method robustness.

•  Support the clinical to commercial product transition in relation to method/instrumentation performance and laboratory investigations, as applicable.

• Participate/Lead in Laboratory investigations as applicable.

• Escalation of Compendial Compliance issues to Team Lead in a timely fashion.

• Perform other duties as designated by Management.                                       

• Take an active role in Continuous Improvement, identify and drive improvement initiatives in line with CI Team.

• Ability to advance and shape the BTDS AD Cork technical analytical capabilities in-line with industry standards.

how to succeed

You will have previous GMP experience and Knowledge/ previous testing experience of Compendial Testing (pH, Colour, Turbidity, Moisture and Osmolality Analysis and Particulates knowledge (Microflow Imaging, Light Obscuration Sub-Visible and Visible Foreign Analysis).

You will also bring:

• A 3rd level qualification in a Biochemistry,Chemistry, Biotechnology, or a related scientific field.

• Efficient and flexible.

• Customer focus and result driven.

• Excellent communication skills.

• Proficient in the use of business applications such as MS PowerPoint, MS Word and MS Excel.

• Ability to think logically, proactive approach with ability to work on own initiative.

• High attention to detail.

• Ability to work well within team structures and provide leadership as required.

Benefits

This role offers a very competitive hourly rate. This contract will run for a minimum of 12 months.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Janssen

Janssen is the Pharmaceutical Companies of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, Limited & Umbrella options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.