Job Description

Job Description

An exciting opportunity has arisen for a Manufacturing Operations Support Specialist (Downstream) for the manufacturing hub at our Dunboyne site. The successful candidate will support the development of the site by leading/participating in cross functional teams to deliver all project milestone, supply, and commercialization activities with a safety first, quality always mindset. As part of the team, drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirement

This role will be part of Downstream Operations Support Team in our Dunboyne BioCEL Facility. The Operations Support Specialist will work with Manufacturing, Automation, Engineering, MS&T and Quality teams to drive operational excellence to deliver all components of a stable process for all commercialization milestones including pre-clinical, clinical PPQ and commercial supply.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

· Managing New production introduction and product change overs

· Change Management - Change control owner for Downstream Product and Equipment Changes

· ACP, GMBR and PVL reviews

· Deviations - QN and CAPA Owner

· Subject Matter expert for Downstream equipment and process

· Troubleshooting and Technical support

· Problem Solving

· Technical reviewer for SOP's, Protocols, Studies, BOMs and DCFD's

· Monitoring of Downstream processing to ensure safety and compliance.

· Working with Automation, Engineers, and MS&T to ensure downstream processing is set-up and fully executable to support production.

· Management of the impact of changes whether through Raw Materials, Automation Recipes, MES systems and Processing Issues, etc. to assure achievement of functional metrics.

· Participate and comply with the internal Quality Management Systems, Environment, Health, and Safety System requirements.

· Drive operational excellence to deliver all components of a stable process for all commercialization milestones including pre-clinical, clinical PPQ and commercial supply.

· Be an advocate of continuous improvement in yield, cycle time, error reduction etc.

What skills you will need:

To excel in this role, you will more than likely have.

· Minimum of a bachelor’s Level 8 degree in a technical, engineering or science-based discipline or equivalent.

· At least 8 years’ experience in the BioPharma Industry with Downstream Processing experience being essential.

· Experience with new product introduction and tech. transfer would be advantageous. Proven capabilities and deep knowledge of design and operation of biologics and downstream startup and manufacturing.

· Experience troubleshooting and optimizing production processes.

· Experience with new product introductions, product change overs, Automation Systems, DCFD's and BOMs is essential.

· Knowledge of UFDF, Chromatography, VI/VF and Formulation is essential.

· Experience managing teams and projects to deliver results is essential.

· Proven record of accomplishments in a regulated industry.

· Thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R315518