Technical Operations Lead (Pharma Manufacturing)

Organon are recruiting a Bulk Technical Operations Lead for our Formulation Technical Operations team at our Cramlington site in Northumberland.

You will lead a team of professionals providing technical support for the introduction and manufacture of tableted pharmaceutical products with responsibility for process validation, cleaning validation and related systems.

This is an exciting role at a time of significant growth at our site where you will be an important member of the site leadership.

Role responsibilities:

• Manage a Technical Operations team of engineers and scientists.

• Provide technical support for all processes involved in the manufacture of oral solid dosage products on site.

• Coordinate and/or initiate the introduction of new or transferred products to site, including assistance with new capital equipment, ensuring timely use, efficient performance, successful validation and optimal process capability.

• Investigate and follow up on issues arising from manufacturing or laboratory deviations, establishing assignable causes for atypical events and propose appropriate actions to minimize rework and improve process capability.

• Lead process and cleaning validation activities on site, provide technical manufacturing assistance with the preparation of validation protocols and oversee in-process validation sampling.

• Demonstrate Operational Excellence through continuous improvement and system robustness improvements with use of appropriate tools such as Lean Six sigma.

• Manage Technical support to Quality and Compliance Initiatives.

Key Requirements:

• Minimum BS in Engineering, Pharmaceutics or related Science, or equivalent industry experience.

• Technical Expertise preferred in oral solid dosage Pharma. Experience in one of the following, API, Biologics, Vaccines, Sterile, Engineering, Analytical.

• Proven Project Management skills in a lean manufacturing environment

• A demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results.

• Demonstrable leadership experience managing a high performance team including coaching and managing direct reports.

• Ability to effectively communicate and align with partners and stakeholders.

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.   

It’s going to be an exciting future—come be a part of it!