Job Description

A fantastic opportunity has arisen for a Senior Specialist in Chemical Technical Operations, External Manufacturing.

The successful candidate will bring energy, knowledge, and an innovation mindset to carry out the following role which is part of the Chemical Technical Operations (CTO) team, a team of engineers and chemists that manage the supply of intermediates and APIs from External Partners (EP) located in the AP region. The position reports to the Director, CTO, External Manufacturing (ExM). The technical lead will be part of the ExM Focused Factory the provides oversight of External Partners in day-to-day manufacturing and supply of products. The technical lead may also be involved in new process introduction and technical transfers to new or existing EPs.

Main responsibilities of the Technical Lead include:

Support technical due diligence assessments at potential EP\xe2\x80\x99s.

Support initial technical transfer of new or existing products to the EP and liaison with the sending site.

Collaborates with Focused Factory team members (Operations and Quality) in the oversight of EPs with an End-to-End mindset.

Proactive partnership with EP\'s to achieve business goals, capacity improvements, mitigate risks and continuously improve performance so as to establish a common culture that benefits both company and EP.

Acting as a point of contact for the EP, provide \xe2\x80\x98calibrated\xe2\x80\x99 technical oversight of manufacturing at the EP, monitor performance, manage change requests and review deviation reports.

Provides rapid responsive support to EPs to resolve manufacturing issues and minimize supply disruption.

During technical transfer and issue resolution, partner effectively and leads the interface with Laboratories groups as well as other Science and Technology groups (Supply Analytical Sciences, Material Sciences etc.) on aligned priorities.

Acting a link between the EP and downstream and upstream (company and External Partners) sites.

Demonstrates consistently a strong quality compliance and EHS mindset in driving excellence in performance of the EP, always ensuring inspection readiness.

Understands the true regulatory requirements and partners with Operations, Quality, Regulatory and the EP in applying efficient ways to meet these requirements.

What skills you will need:

To excel in this role, you will require the following:

Degree in Chemistry or Chemical Engineering an advantage.

Manufacturing experience in the areas of API process production, process development, process optimization, and technical transfer (Min 5 years).

Flexibility and the ability to work independently, with excellent organizational skills.

Strong Leadership attributes including a global mindset, an end to-end supply chain view, ability to collaborate across functions and geographies and multi-task effectively, strong interpersonal and communication skills, ability to establish and maintain strong working relationships with technical, quality and operations leaders in the internal and external network.

The ability to quickly solve technical challenges, to lead project teams, to appropriately apply project management and change execution management principles on complicated projects, and to successfully influence others outside their direct line of authority and in other organizations.

Must have a sound understanding and experience with small molecule pharmaceutical manufacturing processes.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world\'s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today.

Current Employees apply

Current Contingent Workers apply

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 25%

Flexible Work Arrangements: Not Specified

Shift: Not Indicated

Valid Driving License: Yes

Hazardous Material(s):

MSD