![LTS Lohmann Therapy Systems, Corp.](https://media.trabajo.org/img/noimg.jpg)
Research Development Process Engineer
1 month ago
LTS Lohmann is a premier, global Contract Manufacturing and Development Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes.
We Care.
We Create.
We Deliver.
Lohmann Therapy Systems North America is seeking a talented R&D Process Engineer to join our dynamic team.
This is a full time, on-site role located in W. St. Paul, MN
Job Summary:
In this role, you will play a pivotal part in developing, scaling up, and optimizing innovative mixing and coating processes for a diverse range of products, including pharmaceuticals, supplements, and medical devices.
What You Will Do:
- Lead process development activities from concept to commercialization, adhering to QbD principles
- Design and execute experiments, analyze data, and prepare comprehensive reports
- Optimize processes for product quality, throughput, and yield
- Collaborate with cross-functional teams, including R&D, manufacturing, quality, and operations.
- Author documentations packages that include protocols, batch records, SOPs, set up diagrams, and others. Conduct training for relevant personnel on these processes.
- Execute process development trials and author comprehensive reports.
- Ensure regulatory compliance throughout the development lifecycle
- Support equipment specification, installation, and validation
- Transfer developed processes to manufacturing for successful commercialization
Your Background:
- Bachelor's degree in Chemical or Mechanical Engineering or related field (advanced degree a plus)
- Minimum 2 years of industry experience (10+ years for Senior level) in process development and scale-up
- Hands-on experience in mixing and coating processes, preferably within the pharmaceutical industry
- Strong problem-solving, analytical, and communication skills
- Ability to work independently and as part of a team
- Knowledge of cGMP, cGLP, and QbD principles is preferred
Preferred Skills:
- Experience with statistical design of experiments (DOE)
- Proficiency in data analysis and process modeling software
- Knowledge of regulatory requirements for pharmaceuticals
If you are passionate about process engineering and eager to contribute to the advancement of drug delivery, we encourage you to apply.
LTS Lohmann is an equal opportunity employer.
Keywords: R&D Process Engineer, Senior Process Engineer, Mix & Coat, process development, scale-up, pharmaceutical, CDMO, QbD, cGMP, cGLP
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