Technical Development Specialist

The Role: 

The Technical Development Specialist is responsible for assisting with the technical transfer process and regulatory compliance in bringing the company’s products into new markets, manage new product development and existing products, testing requirements, supporting technical requirements with contract manufacturing facilities and ensuring that our products meet high standards of quality and performance.  

What you’ll do: 

Primary Responsibilities:  

• Coordinate with cross-functional teams including R&D, engineering, quality, regulatory and supply chain to align commercial efforts in all phases of ideation and commercialization for cosmetics, OTC, and monographed products.  

• Support scale-ups from prototype to commercial manufacture and following Good Manufacturing Practices (GMP). 

• Supports in the review of R&D stability against testing protocols and finished product specifications to ensure results are within acceptance criteria and tested within assigned stability windows. 

• Prepare samples and support shipping samples to external lab for testing. 

• Support product formulations, review of raw materials and raw material substitutions. 

• Maintains cosmetic and OTC files, documents specifications for various batches. 

• Involvement with CMOs during new product development and management of technical transfers for identification and optimization of critical operations to ensure smooth operational process. 

• Support the testing menu and protocol requirements executed at the CMO. 

• Assist regulatory team and cross functional partners with strategy execution. 

• Lead TT meetings to facilitate and manage the tech transfer tracker updates and timelines.  

• Additional duties as assigned. 
   

What you need to know: 

Experience/Skills/Education: 

Required: 

• 5 - 10 years of experience in the cosmetic and/or pharmaceutical industry, with knowledge in both domestic and international regulation requirements. 

• Bachelor’s degree; preferably in a scientific discipline (Chemistry) or equivalent experience in the skincare cosmetic, device and/or OTC industry. 

• Requires a high level of interdisciplinary knowledge in GLP, GMP, Regulatory requirements, apart from the core scientific knowledge. 

• Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical, and problem-solving skills. 

• Ability to read, understand, and follow test methods, analytical, protocols, testing reports and write technical documentation. 

• Ability to troubleshoot and solve complex problems related to product formulation and development. 

• Proven success working in ambiguity, fostering collaborations in a fast-paced environment. 

• Assures adherence to GMPs, FDA and MOCRA requirements 

• Strong analytical and testing background 

Desired: 

• Technical development in manufacturing experience 

• Validation experience 

• Strong technical foundation of formulated products including emulsions, peels, suspensions, creams, liquids, and an understanding of material chemistry