Job Description

An amazing opportunity has arisen for a Lead Bioprocess Associate in our Company Biotech Swords. You will report to the Manufacturing Shift Manager, Operations.  Your duties will include the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the operation, cleaning, validation, in-process testing and basic maintenance of equipment in accordance with current Good Manufacturing Practices (cGMPs).  The Lead Bioprocess Associate will coach and mentor Bioprocess Associates on an ongoing basis and deliver official training. You will lead operations across the workstreams and function as a key liaison for the shift lead. You will deputise for both the shift technical lead and shift manager at times and provide support across a number of processing areas when required.

What you will do:

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

Work with the manufacturing operations, project and CQV teams, and support functions such as MS&T, engineering, Quality and Tech Ops to facilitate the development and validation of Our Company, Biotech facility manufacturing facility.Support Equipment Design/ HAZOP and Room programming reviews.Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., EHS metrics, Production Plan, OEE, compliance and team training.Organise handovers and ensure issues are recorded and escalated appropriately.Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures.Work as part of a resolute process team where flexibility and teamwork are a key requirement.Generate SOPS/Electronic Batch Records for start-up.Adhere to Right First-Time principals.Aid and/or support maintenance, engineering, quality or other colleagues as requested.Maintain an elevated level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.Liaise with other groups and colleagues to ensure planning of tasks is effective and linked into the manufacturing process plan.Steer project teams and take ownership or actions assigned to shift teams.Direct investigations for safety and quality incidents and use appropriate tools to perform documented root cause analysis

Qualifications

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

Qualification in a science or engineering discipline with a minimum of 6 years Bioprocessing experience in GMP Manufacturing.Exceptional understanding of Upstream Processing.Demonstrated successes in a team environment, and involvement in project teams, Lean initiatives, problem solving and continuous improvement.Proven ability in logical thinking and being proactive under pressure.Demonstrated ability to make decisions and provide support on shift to enable others to participate in decisions.Leadership of projects and lean initiatives and owning follow up actions.Ability to motivate shift colleagues and provide direction to shift teams.

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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, 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 or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, 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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/24/2025

*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:R331862