Job Description
Organon is hiring a Technical Operations Lead to join our world class manufacturing site in Cramlington, Northumberland. In this role, you will provide technical leadership for the technology transfer and commercial manufacture of Oral Solid Dosage (OSD) bi-layer film coated tablets.
Role Responsibilities:
* Develop and lead strategies for process and cleaning validation, provide technical manufacturing assistance with the preparation of validation protocols and oversee execution.
* Provide technical oversight and support for associated processes including change control, Master formulae and recipes.
* Develop and maintain appropriate process monitoring and control systems and oversee formal process reviews and investigations.
* Investigate and follow up issues arising from manufacturing or laboratory deviations, establishing assignable causes for atypical processing events and implementing appropriate actions to improve process capability.
* Ensure effective knowledge management for the product and manufacture process.
* Apply appropriate tools to ensure effective control, visualisation and delivery of activities for example project management.
* Management and leadership of nominated cross-functional teams and specialist tasks.
* Management of personnel within the performance management system, including coaching and mentoring.
* Ensure compliance and provide support to systems including as Quality, Safety, Environmental and Finance.
Qualifications and Experience.
* Demonstrable Experience in pharmaceutical manufacturing within a process support environment.
* Strong knowledge of OSD processes and bi-layer tableting.
* Degree in Science or Engineering, or equivalent.
* Excellent technical communication and influencing skills.
* Effective cross-functional communication and collaboration.
* Project management skills in a lean manufacturing environment.
* Proven ability to anticipate and solve problems, managing multiple priorities and monitor execution to plan.
* Proven ability to develop and maintain successful business relationships with partners.
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Yes
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
10%
Flexible Work Arrangements:
Not Specified
Shift:
Not Indicated
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1