Process Development Engineer

MSD; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

An exciting opportunity awaits as a Process Development Engineer in a forward-thinking company. This role offers the chance to work on innovative small molecule API projects, contributing to the future of pharmaceutical manufacturing. You will collaborate with a multi-functional team, bringing your expertise in chemical engineering to develop new products and technologies. With a commitment to diversity and innovation, this company is dedicated to solving healthcare challenges and improving patient outcomes. If you're passionate about science and technology, this is your chance to make a meaningful impact in the industry.

Qualifications

• Minimum 2 years of experience in pharmaceutical manufacturing.
• Experience in API process development is a distinct advantage.

Responsibilities

• Work with a diverse team to meet product launch milestones.
• Co-develop new SM API products with global partners.

Skills

Chemical Engineering

API process development

Technical transfers

Regulatory compliance

Education

Degree in Chemical Engineering

PhD in Chemical Engineering

Job description

Job Description

An amazing opportunity has arisen for a Process Development Engineer. A new position has arisen in our growing Commercialisation, Development and Supply (CDS) team for a Specialist, Engineering in new small molecule API Commercialisation. 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.

Why you should apply!

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:

Work as part of a multi-functional, diverse team to deliver results within schedule and product launch milestones. Bring energy, knowledge and passion about science and technology 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:

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 or related discipline.
• Experience in API process development and/or API supply is a distinct 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.