Job Description
A fantastic and exciting opportunity has arisen for a Lead Manufacturing Biotech Associate.
This role is a site based role and will involve working shift, on a 24/7 basis.
The Lead Manufacturing Biotech Associate will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement. Reporting to the Shift Lead, this role is a critical role on the manufacturing team, with responsibility focused on a team based commitment to batch progression and technical SME knowledge.
This individual, being the most senior member of the shift suite operations team, will take ownership of the direct activities occurring within a suite. The lead BioTech Associate will act as point person for the progression of the batch, liaising with the Manufacturing shift lead and shift engineer on team delivery throughout the shift.
Bring energy, knowledge, innovation to carry out the following:
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The production of biologic drug substance on their designated shift and act as a coach and a technical point of contact for others on the shift team, acting as a key liaison for the manufacturing shift lead for ongoing operations in a process area.
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Trouble shooting and problem solving in conjunction with the ability to lead the self-directed work teams in their processing area.
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The progression of an automated recipe using paperless technology in order to generate the drug substance
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Setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS principles and driving to optimise and improve the processing activities through use of standard work and lean processing techniques.
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Focusing on delivery to the patient through living the Dunboyne culture including a commitment to safety, focusing on right first time in everything we do and concentrating on the engagement and development of self and peers.
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Act as a coach or mentor to one’s peers on specific unit operations as required to support the value stream
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Lead and sponsor approved projects and continuous improvement initiatives that are in alignment with the site strategies.
What skills you will need:
In order to excel in this role, you will more than likely have:
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Minimum of a Bachelors Level 8 degree in a technical, engineering or science based discipline or equivalent
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At least 5 years’ experience in the biotechnology and/or pharmaceutical industry desirable, (preferably both) or equivalent.
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Leadership Skills – demonstrated ability to lead and achieve outstanding results.
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Proven record of accomplishments in a regulated industry, thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required.
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Ability to think logically and be proactive under pressure.
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Ability to work as part of a team and on own initiative in a constructive manner.
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A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.
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Experience with contamination control and batch release requirements.
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Experience with single-use technologies in a manufacturing environment.
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Experience of upstream and downstream unit operations.
Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting-edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.
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.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing inclusive, talented, and committed people together.
Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Required Skills:
Biologics, Biotechnology, Good Manufacturing Practices (GMP), Shift Work, Team Leadership
Preferred Skills:
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:
Regular
Relocation:
No relocation
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
NA
Job Posting End Date:
06/20/2026
- 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:R400681
