Senior Formulation Scientist

Job Description

Senior Formulation Scientist

Title: Senior Formulation Scientist

Location: Brooksville, FL

Industry: Life Science/Pharmaceutical

Salary: $90k and up Based on Experience

Employment Type: Direct Hire

Overview:

The Senior or Principal Formulation Scientist will be leading formulation development activities on multiple projects. The individual will perform and oversee all aspects of product development including pre-formulation, formulation, technology transfer, scale-up, and registration batch manufacturing activities of sterile injectable products. The individual will work in multidisciplinary teams and with CROs in support of drug product development, scale-up, manufacturing, and regulatory filing. The title will be determined based on qualifications.

Responsibilities:

• Represent product development or CMC development of complex sterile injectable products. Design and conduct pre-formulation, formulation, process, sterilization, scale-up, stability, and container closure studies.
• Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues.
• Prepare manufacturing batch records, technical reports, development reports, and CMC documents to support regulatory submissions (e.g., IND, NDA & ANDA s).
• Represent product development and CMC in cross-functional teams, collaborate with internal and external stakeholders and partners, such as development, Quality, and manufacturing.
• Define scope, timeline, and resource needs of functional activities and keep team on schedule.
• Identify and manage external vendors and partners when needed.
• Participate in evaluation of new product opportunities.
• Follow pharmaceutical cGMP practices and other relevant regulatory guidelines.
• Extended work hours may be occasionally required based on project needs.
  
  

Qualifications:

• Demonstrated success in moving R&D project through multiple development stages; in product development from early stage to regulatory filing.
• Extensive knowledge in advanced drug delivery systems and their pharmaceutical applications, such as emulsions, suspensions, polymer, nanoparticle, and colloidal systems.
• Familiar with common and advanced physicochemical characterization techniques used in the development of complex injectables.
• Familiar with regulatory requirements, such as FDA and ICH guidelines.
• Demonstrated ability to work as part of a cross-functional team.
• Ability to communicate in an open, clear, timely and consistent manner.
• Ability to thrive and to lead in an environment with rapidly changing priorities.
  
  

Education/Experience:

• Ph.D. in Pharmaceutical Science, Chemical Engineering, or related disciplines, with 5 - 7 years of relevant experience in a pharmaceutical R&D environment. (Strong candidates with combinations of education and experience will be considered.)
• Hands-on experience in lab and commercial-scale development of complex injectable products.
• Experience representing functional teams or cross-functional teams is highly desirable
  
  

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

EOE/ADA

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