Job Description

An amazing opportunity has arisen for a Lead Bioprocess Associate in our new state of Manufacture of Commercial Large-Scale Drug Substance Biotech facility.

The successful candidate will be a leader with strong interpersonal, communication and collaboration skills responsible for supporting the manufacturing process, whilst creating an inclusive culture that energizes a safety first, quality always, with a continuous improvement mindset.

What you will do:

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

• Work with the manufacturing operations group and automation to facilitate proficient operations of the Biotech facility manufacturing facility.

• Support the operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, production plan, OEE, compliance and team training.
• Take ownership of the commercial manufacturing processes in your area according to established work instructions and Standard Operating Procedures.
• Co-ordinate a dedicated process team where flexibility and teamwork are a key requirement.
• Provide assistance and/or support maintenance, engineering, quality or other department functions as requested.
• Responsible for all scheduled activities within your area as per Standard work plan and real time schedule.
• Ensure all documentation, both paper and electronic (Logbooks, Electronic Batch records, protocols etc are completed and closed out on time as per Batch record closure practices on site.
• Champion Right First-Time principles.
• Designated person for the escalation process, ensuring all details of issues are communicated as per site procedures.
• Be an advocate for continuous improvement.
• Determine solutions by referencing relevant past experiences as part of problem. solving activities.
• Participate in internal audit programs and risk assessment compliance activity.
• Lead by example through coaching & mentoring on MPS systems skill transfer.

Qualifications

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

• Degree qualification (Science/Quality/Technical).
• 6+ years’ experience in Biopharma or similar
• Preference Lean Six Sigma
• Experience in a highly regulated drug substance manufacturing environment is essential.
• Start-up experience in a large-scale commercial drug substance facility desirable but not essential.
• Excellent understanding of Downstream Processing
• Experience in leading a small team within a specified area in a manufacturing environment

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:

05/8/2025

*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.