Job Description
An amazing opportunity has arisen for a Process Scientist. You will play an important role within our vaccine manufacturing MSAT lab, primarily providing process support to upstream and downstream lab scale experiment planning and execution.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
* Lead and support upstream and downstream related studies at small scale in MSAT lab.
* Strong background in setting up cell culture seed train, bioreactors setup and running process smoothly.
* Strong background in TFF, clarification, filtration and dilution of drug substance.
* Write reports to a high standard and present data within the group.
* Working flexibility to support weekend work if required.
* Support manufacturing to perform any study required during, engineering, validation or clinical batches.
* This role will support satellite runs of vaccine process to ensure the efficient and consistent production of vaccines.
* The ideal candidate will possess a deep understanding the drug substance process as well as a passion for problem-solving and process improvements in a GLP environment.
* Ensure a high standard of record keeping and documentation of experiments and investigations.
* Support in drafting SOP, protocols, MBRs and other technical documents and revision of documents including technical memo.
* Have in depth knowledge of vaccine drug substance process and understand the basis of specification and critical attributes.
* Participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
* This role will partner with the MSAT team and DS Technical team to provide comprehensive technical leadership to DS manufacturing.
* Support equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
* Work closely with manufacturing, and quality teams to ensure smooth and robust process.
* Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the DS MSAT lab area.
What skills you will need:
In order to excel in this role, you will more than likely have:
* Masters or Bachelor's degree in Biology, Biotechnology, Microbiology, Chemistry or Pharmaceutical Engineering or related Science or Engineering major or equivalent experience.
* Minimum 2-3 years working in a biological, or vaccine clinical or commercial manufacturing.
* Experience in cell culture process development and bioreactor operation.
* Experience in downstream process development.
* Experience in bioprocess development, biopharmaceutical production, and/or biological process validation experience with successful tracking record.
* Biological production process validation experience will be an advantage.
* Have knowledge and understanding of biopharmaceutical cGMP quality systems and operation will be an advantage.
* Have excellent oral presentation skill for internal and external meeting.
* Detail-oriented organizational skill to track and maintain project activities.
* Experience in troubleshooting and investigating critical deviation, performing risk analysis on production process, coordinating technical transfer, and executing process validation.
As a company, 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:
Adaptability, Adaptability, Bioprocess Engineering, Bioreactors, Cell Cultures, cGMP Guidelines, Electronic Batch Records, Evidence Handling, Experimental Methods, Experiment Planning, Laboratory Experiments, Leadership, Mammalian Cell Culture, Personal Initiative, Pilot Plant Operations, Primary Cell Culture, Process Engineering, Process Improvements, Process Optimization, Product Formulation, Recordkeeping, Records Management Compliance, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Teamwork {+ 2 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:
02/7/2026
*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:R376681