Technical Operations Lead (Pharma Manufacturing)

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. 

Search Firm Representatives Please Read Carefully 

Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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

Requisition ID:R529422

Read Full Description