Job Title

Requisition

Location

Additional Locations

Job Description

The Sr Formulation Scientist will assume a key functional role within Global Technical Operations. The Sr Formulation Scientist will be responsible for providing formulation and aseptic fill/finish expertise for late-stage drug product development and commercial manufacturing initiatives. This includes conducting laboratory-scale formulation and fill/finish experiments for process optimization, scale-up and tech transfers. The Sr Formulation Scientist will also be responsible for providing on-site oversight of commercial manufacturing campaigns at external manufacturing partners.

• Conduct laboratory formulation and fill/finish experiments to establish critical process parameters for drug product manufacturing.

• Travel to contract manufacturing organizations to provide oversight of drug product development, manufacturing and tech transfer initiatives.

• Provide routine technical support to External Operations and Quality to ensure successful manufacturing campaigns.

• Interrogate and interpret experimental data and present conclusions at project meetings and technical forums.

• Collate data, author, and review reports for drug product CPV programs.

• Evaluate and propose opportunities to enhance robustness and efficiencies of drug product manufacturing processes.

• Author relevant sections for regulatory dossiers and submissions.

• Maintain detailed laboratory notebook records and demonstrate safe work habits within the laboratory.

• Represents a Formulation Sciences function as a core team member for Operations and Quality projects.

• Maintain awareness of advances in drug product development science and fill/finish technologies.

• Proactively apply scientific or engineering expertise to develop solutions to complex technical, operational, and/or business problems.

• PhD in Pharmaceutical Science, Chemistry, Chemical Engineering, Physics, or related scientific disciplines, and at least 3 years of pharmaceutical or related work experience in the field.

• MS in Pharmaceutical Science, Chemistry, Chemical Engineering, Physics, or related scientific disciplines and at least 5 years of pharmaceutical or related work experience in the field.

• BS in Pharmaceutical Science, Chemistry, Chemical Engineering, Physics, or related scientific disciplines and at least 8 years of pharmaceutical or related work experience in the field

• Hands-on experience and knowledge of aseptic fill/finish equipment.

• Working knowledge of GMP drug product manufacturing, including aseptic and terminal sterilization processing and lyophilization.

• Proficient with statistical analysis tools such as Design of Experiments, Regression Analysis, etc.

• Familiarity with requirements of various pharmacopeias (USP, EP, JP)

• Self-starter with strong work ethic, excellent written and verbal communication skills; the ability to successfully conduct or manage various formulation projects in a timely manner.

• Ability to work in a team environment and operate with limited supervision.

• Demonstrates strong organizational and planning skills; excellent interpersonal skills with ability to work in a team environment.

• Demonstrates capability and comfort in communicating and interfacing with all levels in the organization including management and senior management.

• Ability to understand overall project timelines and manage prioritization of individual contributor deliverables with appropriate supervision.

Preferred Qualifications

• Experience with aseptic filling of viscous formulations

• Experience with Minitab and/or JMP software packages

This position requires frequent work in a research laboratory, both standing at a bench and seated. It also requires reaching into flammable cabinets. This position involves frequent work in an office environment, using a computer to analyze data, write reports, and document experiments in notebooks. Occasional travel will be required for engagement with external laboratories and collaborators and oversight of CMO manufacturing campaigns.

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