Senior Formulation Scientist-Oral dosage

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Job description

**Kelly Services is seeking a Senior Formulation Scientist for a Direct Hire role in St. Louis, MO**

Our client is a pharmaceutical research and development company which focuses on research and development of novel therapeutics for unmet medical needs. They work towards improving patients' quality of life and are committed to creating a healthier world of tomorrow. They are looking for people who are passionate about making people's lives better.

With their recent expansion in the U.S., they are currently seeking a highly motivated **Senior Formulation Scientist with proven track record in various dosage forms development, especially in oral product development.** This role will be leading pharmaceutical development activities on multiple projects. The individual will perform and oversee all aspects of product development including **pre-formulation, formulation, technology transfer, scale-up, registration batch, and facilitate regulatory filings of ANDAs and 505(b)(2).** The individual will work in multidisciplinary teams and with CRO/CMOs in support of drug product development, manufacturing, and regulatory filing.

**Job Responsibilities**

• Lead product development from initial R&D up to final product approval with minimal guidance, including pre-formulation, formulation, process, stability, and container closure development studies by QbD for oral dose pharmaceutical products that include IR and ER tablets/capsules (single- or multiple-layer matrix tablets, gastro-retentive tablets, etc.), liquid dosage forms (solution and suspension), and ADF (abuse deterrent formulation) dosage forms.

• Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues, including complex formulation, stability, and manufacturing issues.

• Prepare technical reports, presentations, and CMC documents to support regulatory submissions.

• Represent formulation or CMC in cross-functional teams, collaborate with internal and external stakeholders and partners, such as manufacturing and clinical BE.

• 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.

• Develop and mentor junior scientists.

• Extended work hours may be occasionally required based on project needs.

• Ability to travel domestically and internationally up to 25% of time.

• Additional duties and assignments as needed.

**Required Qualifications and Skills:**

Ph.D. in Pharmaceutical Science, Chemical Engineering, Chemistry, or related disciplines, with at least 3 years of relevant experience in a pharmaceutical R&D environment.

• Demonstrated success in product development from early-stage to regulatory filing.

• Hands-on experience in lab and commercial-scale development of complex oral products. Experience in other dosage forms is a plus.

• Extensive knowledge in advanced drug delivery systems and their pharmaceutical applications on ANDAs and 505(b)(2).

• Experience leading functional teams or cross-functional teams is highly desirable.

• Demonstrate leadership ability and excellent oral and written communication skills in an open, clear, timely and consistent manner.

• Ability to thrive and to lead in an environment with rapidly changing priorities.

**APPLY NOW!**

**For immediate consideration, please send your resume in a WORD document to **

\#TJP2021_SPEC

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**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ()