Sr. Spclst, External Manufacturing

Job Description

About the Role

An amazing opportunity has arisen for a Technical Lead to join our Small Molecule API Chemical Technical Operations Unit. In this role you will support drug substance tech transfer and commercial manufacture within our External Manufacturing Network. You will work with key strategic external partners grow technical experience in API manufacturing and contribute to high visibility network initiatives.

You will be responsible for managing the technical interface between our company and External Partners providing process support to resolve production issues evaluating and managing process change requests assessing and managing process/technical risks and guiding process improvement and capacity optimization.

Additionally you will oversee External Partners during New Product Introductions and Technical Transfers identifying risks during pre-execution providing on-site support during execution and supporting post-execution activities. This position reports to the Director Chemical Technical Operations External Manufacturing API Technology.

What you will do:

• Work with external partners to achieve business goals and establish a common culture benefiting our company external partners and patients.
• Lead and act as the primary interface on technical issues between Chemical Technical Operations and external partner API manufacturers.
• Manage technical transfer activities through review of GMP documentation (e.g. Master Batch Records change control protocols reports qualifications).
• Oversee technical activities for commercial manufacturing processes at external partners including authorship of change control management of process improvement projects statistical analysis of process performance and investigation of atypical events.
• Develop solutions to complex technical issues requiring ingenuity creativity and innovation applying principles and standards governing sterile product manufacturing.
• Provide on-site coverage at external partners to support commercial and/or tech transfer personnel during plant activities.
• Translate GMP requirements and current regulations into standardized work by partnering with operations quality and external partners.
• Ensure external partners are inspection ready for routine inspections and inspections related to new product introductions or transfers collaborating with operations quality and regulatory teams.
• Participate in creating sharing and adopting best practices and business process strategies.

What You Bring:

In order to excel in this role you will more than likely have:

• Bachelors degree in Chemistry Chemical/Biochemical Engineering Pharmaceutical Science or other related science or engineering field
• Experience in API chemical manufacturing in an API manufacturing facility
• Knowledge of GMPs in API manufacturing
• Minimum of 7 years post-bachelors degree experience in a GMP functional area or support of a GMP functional area such as Operations or Technical Operations
• Experience in Quality Risk Assessments deviation management and change control
• Strong analytical problem-solving skills root cause analysis and risk assessment/mitigation
• Experience in Tech Transfers
• Ability to work independently as well as excellent organizational skills
• Strong professional and interpersonal communication skills
• Accomplishment oriented (self-motivated and persistent) possess a business owner mentality possess the ability to influence without authority and demonstrate the ability to effectively operate in an ambiguous/changing environment
• Must be able to multi-task and work within tight deadlines
• Proven collaboration and team building skills
• Working Across Boundaries Must possess excellent interpersonal communication collaboration negotiation skills to work outside boundaries as a norm
• Excellent command of English. Spanish at a conversational level
• Travel up to 50% will be a requirement of this position (Person in Plant support during Technical Transfers at External Partners)

• Project management experience
• Knowledge of worldwide regulatory requirements experience supporting regulatory inspections

Why Join Us

As a company we are committed to Inventing for Life in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So if you are ready to take on a challenging and rewarding role where you can make a significant impact in API manufacturing and collaborate with leading external partners please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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