Operations Lead Biotech Associate

Job Description

A fantastic and exciting opportunity has arisen for an Operations Lead Biotech Associate.

This role is open to applicants with both Upstream and Downstream experience.

This is a site-based role 24/7 shift role (4 on 4 off).

What you will do:

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

• Support end-to-end production operations within the specific Manufacturing IPT.
• Act as a Unit Op Lead, take ownership of activities within the assigned suite and unit operation, and act as a delegate for the shift lead when unavailable.
• Carry out and support assigned operations, delivering shift standard work through a team-based approach to batch progression.
• Execute manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
• Run handover boards and provide key updates to shift leads for handover.
• Act as the escalation point of contact (POC) for troubleshooting, task execution, problem solving and continuous improvement (CI) projects. Support resolution of issues and delays, and escalate unresolved issues to the shift manager or operations lead.
• Document executed activities Right First Time (RFT), ensuring accountability and traceability of production records and compliance with good manufacturing practices.
• Ensure Electronic Batch Record (EBR) and related documentation reviews are completed accurately. Confirm by the end of the shift that all activities are correctly completed, including real-time batch record, SAP Comet and elogs reviews.
• Author, review and/or edit procedures and technical documents in accordance with cGMP requirements, including support for electronic batch records, sampling plans, work instructions and SOPs.
• Coach shift teams on RFT documentation and adherence to Right First-Time principles.
• Maintain and support high standards of safety and Good Manufacturing Practice (GMP) compliance at all times. Identify and challenge opportunities to improve site safety and environmental programmes.
• Promote EHS leadership behaviours, engage employees at all levels on EHS issues and visibly lead safety initiatives, including active involvement in safety forums.
• Promote an environment where everyone speaks up for our culture of safety and looks out for one another.
• Participate in safety walkdowns, internal audits, inspections, risk assessments, GEMBAs and Go-Sees, and support implementation of agreed actions.
• Support incident investigations and audits, including investigations arising from manufacturing documentation, and ensure improvement actions are implemented.
• Coach and provide oversight on the shop floor to identify potential issues before they arise.
• Provide coaching on CAPAs, change actions, SOP updates and training module development or revision for the assigned area or unit operation.
• Actively participate in cross-functional manufacturing teams to advance projects, goals and deliverables.
• Lead approved projects and continuous improvement initiatives aligned with site strategies, and support site functional initiatives to improve compliance and operational efficiency.
• Utilise real-time data analytics to inform decisions on value stream improvement initiatives.

What skills you will need:

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

• Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy or Process Engineering.
• 5+ years’ experience in the biotech industry, including bulk manufacturing of pharmaceutical or biological components.
• Familiarity with contamination control and batch release requirements.
• Proficiency with Delta V, Pas X and the use of automation in a manufacturing process.
• Experience with various single-use technologies in a manufacturing environment.
• Competence in troubleshooting and practical problem solving.
• Ability to work independently and within a cross-functional team.

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 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.

Additional location(s) Compensation Information:

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

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