Job Description

The position is a technical leadership role, reporting to the Director, Chemical Technical Operations, External Manufacturing API Technology.

The Technical Lead will be responsible for the management of the technical interface between Merck and External Partners (EP) for API and Intermediates.

The technical lead will provide process support to External Partners in the External Manufacturing (ExM) Focused Factory to resolve production issues, evaluate and manage process change requests, proactively access and manage process/technical risks, and provide guidance on process improvement and capacity optimization.

Responsibilities

Functions independently with minimal oversight

Provides a single point of technical contact to assigned EP's in Focused Factory and coordinates with impacted (downstream and upstream) MSD sites and External Partners.

Collaborates with Focused Factory team members (eg. Operations and Quality) and others to facilitate supply of products from EPs with an End-to-End mindset.

Initiate and drive change controls to completion

Provide technical transfers and validation support as well as development of plans to meet capacity needs

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

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

Demonstrates consistently a strong compliance and EHS mindset in driving excellence in supply performance in the Focused Factory, ensuring inspection readiness at all times.

Partners effectively and leads the interface with Merck Research Laboratories (MRL) groups (Process Chemistry, Chemical Engineering R&D, Analytical R&D), as well as other Merck Science and Technology groups(Supply Analytical Sciences, Center for Mathematical Sciences, Material Sciences etc.) on aligned priorities.

Executes technical due diligence assessments at potential EP’s.

Provides expert consultation and review of chemical manufacturing technical matters.

Provides a 'calibrated' technical review of EP process change requests and deviation reports.

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

Desired Qualifications / Experience

BS/ MS / Ph.D in in chemical/biochemical engineering, pharmaceutical science or chemistry or related fields

Minimum of 7 years of post-BS experience, including manufacturing experience in the areas of API process production, with demonstrated experience in process start up, process optimization, and technical transfer

Experience in biological manufacturing including fermentation, chromatography, and downstream purification is a plus.

Experience in leading technical teams in the areas of process development / commercialization / tech transfer / supply of API products

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

Strong Merck 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