Principal Scientist, Oral Formulation Sciences

Job Description

Principal Scientist Job Description:

Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients.

The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for leading CMC project teams and the formulation development of new chemical entities through a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment. This individual will also be responsible for driving new technology strategy, scientific understanding and capability builds within the organization.

Primary Responsibilities:

Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis to impact pipeline development and set strategic direction

Mentors technical staff to develop team members scientifically and support the execution of pipeline programs

Ability to spearhead Due Diligence of potential pipeline assets and drug delivery technologies, including representing PSCS on cross-functional teams to make strategic and technical recommendations to leadership

Sets direction and coordinates technology development efforts in emerging drug delivery areas

Drives evaluation of new technologies and leads capability build to deploy them to pipeline assets

Collaborates effectively within and across functional areas to lead the development of novel drug delivery technologies

Is a recognized subject matter expert in at least one area of drug delivery and/or drug product manufacturing technology

The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results

Can independently execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities while also helping to coach others in a collaborative environment

Coordinate development activities with chemistry, analytical, and physical characterization groups

Leads project activities at external manufacturing sites

Facilitate manufacturing, packaging and release of clinical supplies for clinical studies, assist in scale up activities at pilot and commercial scale, and summarize results in technical reports and presentations

Enhance our company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations

Builds and maintains awareness of relevant and emerging technologies and capabilities at a department level to develop institutional understanding and develop staff across the organization

Education Minimum Requirement:

Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years relevant industry experience.

M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 10 years relevant industrial experience.

B.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 14 years relevant industrial experience.

Required Experience and Skills:

Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process

Ability to lead complex teams in the development of new molecules and new technologies that shape drug delivery strategy across our company

Extensive experience with conventional and novel drug product technologies that can be utilized to develop pipeline assets, including hands on experience to independently operate in a pilot plant as well as an in-depth understanding of the science to train others in the department

Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas

Has broad knowledge of formulation science and in-depth knowledge in multiple areas, including core understanding of the drug development process, excipient attributes, and formulation-process interplay

Demonstrated ability to independently design, execute and lead complex experiments and data analysis

Track record of working effectively with team-members of skill sets and backgrounds

Strong verbal and written communication skills

Preferred Experience and Skills:

Prior experience leading development projects at an enterprise level

Strong mentoring capabilities to build individuals and teams

Recognized as a subject matter expert in multiple drug delivery and/or manufacturing technology

Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies.

Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.

Ability to engage others to build a strong scientific community and address drug delivery challenges.

Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems

Required Skills:

Adaptability, Biomedical Engineering, Chemical Engineering, Combination Products, Data Analysis, Design of Experiments (DOE), Drug Delivery, Drug Formulations, External Manufacturing, Innovative Thinking, Leadership Mentoring, Life Cycle Planning, Manufacturing Processes, Manufacturing Strategies, Manufacturing Techniques, Matrix Management, Perform Testing, Pharmaceutical Process Development, Pharmaceutical Process Engineering, Pharmaceutical Sciences, Pilot Projects

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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