About LTS:

LTS Lohmann Therapy Systems is a premier, global Contract Development and Manufacturing 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.

Job Summary:

Lohman Therapy Systems North America is seeking a talented Product Development Scientist who will play a pivotal role in developing and optimizing novel sublingual/buccal films and transdermal patch dosage forms. You will lead formulation and product development efforts from concept to commercialization, collaborating with cross-functional teams to ensure timely and successful project execution.

This is a full-time, on-site role located in West St. Paul, MN.

***Relocation is not provided for this role.***

What You Will Do:

• Lead formulation development activities, including pre-formulation, formulation, and product development.
• Contribute to multiple development programs for both novel and generic products.
• Collaborate with the Business Development team to evaluate new business opportunities.
• Establish and implement methodologies, tools, and know-how for successful formulation and product development.
• Work closely with clients to understand product requirements and communicate project progress.
• Collaborate with the R&D Analytical team to develop analytical methods and characterize formulations/products.
• Conduct various formulation and product characterization studies, such as stability studies, excipient compatibility, forced degradation, solubility screening, etc.
• Collaborate with the R&D Process Development team to transfer formulations/products to manufacturing.
• Generate clear and comprehensive formulation development reports to support regulatory submissions.
• Prepare documentation packages for raw materials, in-process materials, and finished dosage forms.
• Mentor and train junior team members.

Your Background:

• Master's or Ph.D. in a scientific or engineering field.
• 5-10 years of experience in formulation and product development, with a strong preference for experience in sublingual/buccal and/or transdermal patches.
• Demonstrated ability to troubleshoot formulation and drug product issues.
• Experience developing and using analytical methods for product testing (HPLC, dissolution, disintegration, etc.).
• Knowledge of CMC-related regulatory requirements and cGMPs.
• Excellent technical writing and communication skills.
• Strong organizational skills and ability to manage multiple priorities.

Preferred Qualifications

• 7+ years of experience in the FDA drug/pharmaceutical industry.
• Knowledge of FDA, OSHA, DEA, cGMPs, and cGLPs regulations.
• Experience in analytical method development and validation.
• Experience in developing pharmaceutical dosage forms, particularly transdermal delivery systems and thin oral films.
• Experience in statistical data analysis and QbD principles.
• Advanced understanding of polymer science, analytical development, drug and formulation characterization, optimization, and scale-up.

We Offer

• Competitive compensation and benefits package
• Opportunities for professional growth and development
• A collaborative and supportive work environment
• The chance to contribute to improving patient lives

If this sounds like you, we want to hear from you!

LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.