£33k – £46k per annum

Job Details:

Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open Senior Specialist, Technical Operations, to support drug substance manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics or vaccines manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the large molecule line of business at our company.

Primary responsibilities for this position include, but are not limited to, the following:

• Work with external partners to achieve business goals and to establish a common culture that benefits both our company, external partners, and patients.
• Lead and act as the primary interface on technical issues between technical operations and external partner drug substance manufacturers.
• Responsible for technical activities for the commercial manufacturing process at the external partner.
• Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation and regulatory filings.
• Develops solutions to complex technical issues that require a high degree of ingenuity, creativity, and innovation. Requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products. Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities.
• Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners.
• Ensure that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory.

This role is an onsite role based in Co. Louth.

Education and Minimum Requirements:

• Bachelor’s degree in engineering, biological/chemistry sciences, or related discipline with a minimum of 5 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer.

Required Skills and Experience:

• Minimum of 3 or more years of experience in Drug Substance Technical Transfers
• Ability to work effectively across boundaries to build strong collaborative relation with other internal teams, such as; Global Technical Operations, External Services partner groups, and ex ternal partners.
• Strong professional and interpersonal communication skills are required.
• Must be able to multi-task and work within tight deadlines.
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• Flexibility and the ability to work independently as well as excellent organizational skills.
• Strong knowledge of Quality systems, Drug Substance Manufacturing and Validation.
• Strong analytical problem-solving skills, root cause analysis and risk assessment/mitigation

Travel will be a requirement of this position at approximately 25%

Ideal Experience and Skills:

• Experience in Live Virus Vaccine DS
• Lean Manufacturing / Six Sigma Experience
• Project management experience
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

Current Employees apply HERE

Current Contingent Workers apply HERE

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About Us:

The Company’s existing portfolio and future pipeline offers team members the opportunity to operate at the cutting-edge of science and technology and develop new treatments that positively impact patients across the globe.

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 world’s 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:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today

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

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