Job Description

An amazing opportunity has arisen for a Lead Manufacturing Biotech Associate.

Key responsibilities include project management and problem-solving, addressing issues as they arise to maintain operational efficiency. The Lead BTA will act as a technical subject matter expert (SME) for manufacturing processes, contributing to new projects and initiatives. Additionally, the role encompasses training new employees, ensuring they meet operational standards and are effectively integrated into the team.

This position provides a pathway to develop people management skills, with opportunities to lead and mentor team members. It also involves cross-functional collaboration with the Drug substance leads and Engineering, fostering relationships across teams to improve operational outcomes. Reporting directly to the DS lead, the Lead BTA ensures alignment with site objectives and operational goals. Overall, this role is an excellent opportunity for individuals seeking to advance their careers in biotech manufacturing, offering a blend of technical expertise and leadership development.

This role is a site-based position. This role will involve working shifts.

What you will do:

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

• 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 DS lead for ongoing operations in a process area.
• 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.
• Build safety as a value within every aspect of the value stream supporting operations.
• Help create a team environment that keeps safety at the front of mind of the team driving continuous improvement.
• Role model the behaviours that creates a culture of respect and dignity in line with our company’s  Guide to ethical conduct.
• Drive the production process forward through use of Delta V recipes & Electronic Batch records according to relevant SOPs
• Take ownership for one’s own training to continue professional development and generate expertise in the role
• Assist in project activities as they arise to maintain and optimize the facility
• Help create an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
• Trouble shooting and problem solving in conjunction with the ability to lead the self-directed work teams in their processing area.
• The progression of an automated recipe using paperless technology in order to generate the drug substance through inoculation and cell culturing activities leading to filtration and purification of the product.
• Focusing on delivery to the patient through living the Dundalk 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.
• Act as a coach or mentor to one’s peers on specific unit operations as required to support the value stream
• Lead and sponsor approved projects and continuous improvement initiatives that are in alignment with the site strategies.
• Act as primary delegate for the DS lead during emergency events.

What skills you will need:

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

• Minimum of a Bachelors Level 8 degree in a technical, engineering or science based discipline or equivalent
• At least 5 years’ experience in the biotechnology and/or pharmaceutical industry desirable, (preferably both) or equivalent.
• Leadership Skills – demonstrated ability to lead and achieve outstanding results.
• Proven record of accomplishments in a regulated industry, thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.

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.

Required Skills:

Accountability, Accountability, Adaptability, Applied Engineering, Biopharmaceutical Industry, CNC Manufacturing, Communication, Computer Literacy, Continuous Process Improvement, Cross-Functional Collaboration, Fabrication Processes, GMP Compliance, Good Manufacturing Practices (GMP), Inventory Management, Machinery Operation, Management Process, Manufacturing Processes, Material Selection, Operational Efficiency, Operations Support, People Management, Problem Solving, Process Improvements, Production Planning, Production Scheduling {+ 4 more}

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/11/2026

*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.