Senior Formulation & Developmental Scientist

Are you a skilled formulation chemist looking to take the next step in your career?

Have you got experience working in an R&D setting, developing formulations for novel small and large molecule API's?

Our expanding pharmaceutical development team in Shawnee are recruiting for an experienced formulation scientist. In this role you will apply formulation expertise to guide product development through to registration and subsequently commercialization.  As a Senior Formulation and Developmental Scientist you will conduct formulation development work including pre-formulation and formulation characterization whilst supporting process development and manufacturing as required.

You will be able to provide technical advice, produce data and reports to support the formulation development process from initial concept through to scale up.

The Formulation & Developmental Scientist will provide value through the following responsibilities: 

• Lead formulation development for small molecules, biologics, and large molecule therapeutics, from early stage discovery to clinical manufacturing.
• Design, develop, and optimize solid and liquid formulation, including injectables, oral dosage forms, and biologic delivery systems.
• Conduct stability studies and analytical testing to ensure optimal product performance and regulatory compliance
• Prepare and review regulatory submission documentation related to formulation and development activities
• Communicate progress of projects effectively to senior managers
• Organization of development laboratory, equipment and consumables
• Writing and reviewing SOPs, Work Instructions and Risk Assessments
• Collaborate with cross functional teams (e.g. analytical development, tech services, quality assurance, regulatory affairs and clinical) to support product development and commercialization. 
• Manage own workload and assignments to meet all internal and external deadlines for maximum efficiency and accuracy
• Comply with all aspects of site and company Health and Safety

What do you bring to Argenta?

This role is an excellent opportunity to help shape the future direction of the Pharmaceutical Development group at Argenta. You will have the opportunity to work on a variety of client projects at all stages of product development. This role encompasses project management and ownership of client relationships, as well as supporting lab work as required.

The Senior Formulation and Developmental Scientist will actively support an environment of formulation, technical innovation, and continuous improvement. Working within a mixed matrix team (Project management, QA, QC, Analytical, Clinical, etc.) and external contractors to support the development activities to achieve project objectives. This individual would ideally meet the following requirements:

• A minimum of 10 years of experience in formulation development within the pharmaceutical or biotechnology industry. Experience in animal health is preferred.
• Bachelor's, Master's, or PhD in Pharmaceutical Sciences, Chemistry, Biotechnology or a related field
• Expertise in both small molecule and biologics formulation development, including working knowledge of biologic modalities (e.g. monoclonal antibodies)
• Strong understanding of drug delivery technologies, excipients, and regulatory requirements for clinical and commercial product development.
• Proven track record of successful drug product development and registrations
• Experience with stability studies, scale up and technology transfer processes.
• Experience in mentoring junior colleagues
• Experience in designing and executing pre-formulation studies, including physiochemical assessment, solubility assessment and dissolution studies
• Be able to support the design of appropriate formulation and stability studies including the use of QbD where appropriate
• To be innovative and creative with an appreciation of new technologies and the reasons that drive innovative thinking
• Be able to build knowledge of current industry trends and topics
• Excellent written and verbal communication, including technical writing
• Detail oriented with the ability to work globally and under tight deadlines
• Be able to follow often complex operating procedures
• Sense of urgency (Action oriented/drives for results)
• Team oriented/strong team player building positive relationships with others
• Excellent time management, prioritization, and organization skills

This position is subject to a DEA background check post offer and at regular intervals.  This position is also required to complete a post offer drug test. Both the background and drug test must comply with company standards or offers of employment will be rescinded.

You will also be someone who is aligned with our company values of "We are Doers, We are Team Players, We are Innovators, We are Customer-Centric".

We pride ourselves on the uniqueness of our development and manufacturing abilities and the skills and qualities of our team.

Want to know more about Argenta? Visit our website www.argentaglobal.com

Equal Opportunity Employer