Job Description
An amazing opportunity has arisen for a Specialist, Engineering. This role provides exciting and interesting opportunities to work on multiple API projects, ranging from manufacturing support activities to late-stage clinical product development and scale-up, new product introductions and technology transfers across our existing and new facilities of the future.
Small Molecule (SM) Active Pharmaceutical Ingredient (API) manufacturing is changing with the pipeline of the future including molecules of increasing complexity (such as ADC’s and macrocyclic peptides), lower volume and higher potency products and increasing utilisation of new and sustainable technologies such as flow chemistry, continuous manufacturing, photo, and biocatalyst driven chemical synthesis. To enable this change, we are investing in flexible facilities and infrastructure with small-scale trains for multi-product commercialisation for low volume and high potent API. The facilities will manufacture APIs for late phase clinical, launch and early commercial supply using both batch and continuous manufacturing technology.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
- Individual contributor on new product introductions and/or technical transfers to and from the site, including new technologies.
- Co-develop new SM API products with Research and Development partners globally.
- Provide knowledge and subject matter expertise on API processing unit operations and scale up to colleagues in Quality, Supply Chain and Manufacturing Operations.
- Evaluation of raw materials, development of process fits, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring and cycle-time studies, deviation investigations and resolution, and development of filing strategies.
- Development of batch documentation in compliance with cGMPs and EHS policies
What skills you will need:
In order to excel in this role, you will more than likely have:
- A degree in Chemical Engineering or related discipline and a minimum of 2 years post-graduation experience in a pharmaceutical manufacturing organisation, or a PhD in Chemical Engineering, Pharmaceutical Sciences, or related discipline.
- Experience in process modelling/simulation and/or data analytics would also be an advantage.
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.
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:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/30/2024
*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:R312374