PAT Scientist

General Purpose of Position:

This position is responsible for the development and implementation of Process Analytical Technology (PAT) on Aprecia’s proprietary technology platforms. This position will support product and process development by applying expertise in the identification and deployment of analytical techniques for real-time process monitoring and process control. This position will support and contribute to innovative applications of PAT for the advancement of intellectual property.

Primary Duties and Responsibilities (Essential Functions):

Duties/Responsibilities

1 Development and implementation of Process Analytical Technology methods and instrumentation in innovative pharmaceutical manufacturing processes on Aprecia’s proprietary technology platforms.

2 Support product development by generating analytical data and reports using a structure that ensures the information can be used for regulatory submissions. Provide data analytics support to Aprecia operational groups.

3 Manage utilization, qualification, and validation of PAT methods and instrumentation in support of product development, scale up, and technology transfer activities including transferring methods from non-GMP to GMP status.

4 Develop analytical methods that deliver real-time process monitoring in support of a process control strategy for the Aprecia platforms. Contribute to the integration of analytical systems into processing equipment.

5 Prepare and review technical documents, analytical test procedures, investigation reports, and change control policies.

6 Identify, evaluate, and implement innovative technologies that keep Aprecia at the forefront of measurement science and contribute to Aprecia’s Intellectual Property.

Reporting to this Position:

No Direct Reports

Travel:

Position may require 0-20% travel

Work Shift:

This position works days

Knowledge, Skills and Abilities:

Understanding of multivariate methods of analysis as applied to the implementation and validation of PAT methods and instrumentation

Strong organization and project management skills

Excellent oral and written communication skills, with the ability to communicate effectively with innovators, technologists, and business leaders. Strong problem solving, critical thinking, attention to detail, and presentation skills

Must have the ability to multi-task, manage multiple priorities, and deliver results in a fast-paced environment.

Understanding of the regulatory environment in pharmaceutical manufacturing, particular concepts of GMP and measurement systems for product processing and product release. Education and Experience:

BS or MS in Biology, Bio Engineering, Chemistry, Chemical Engineering, Materials Science, Pharmaceutics or related field is required, PhD is desired

2+ years of experience utilizing PAT in chemical manufacturing or pharmaceutical manufacturing (will consider 0+years of experience if PhD with PAT focused research)

Experience with Unscrambler, Vektor Director, or similar chemometric software is required

Experience in spectroscopic techniques such as NIR, Mid-IR, Raman and UV

Experience in data analytics, preferably containing chemometric analysis of spectroscopic data

Experience in industrial vision systems such as inline cameras, SWIR, laser measurement is preferred

Experience in process automation and controls systems, including concepts of model-based control and adaptive control is preferred

Understanding of how to achieve good spectroscopic measurements in terms of representative sampling, acquiring good S/N data and dealing with the adverse effects of a process environment

Knowledge of sampling dynamic systems involving flowing powders and liquids

Understanding of the data preprocessing, model construction and validation sequence used for PAT application development

Experience with the basic algorithms used for spectroscopic analysis (PCA, PLSR)

Understanding of sensor integration into IT infrastructure and into a process environment preferred

Experience in technology development and maturation from early proof-of-concept to production scale implementation preferred

Hands-on experience operating/troubleshooting/testing/improving in-line or at-line process monitoring and control instrumentation required

Experience in the pharmaceutical industry, including management of projects and familiarity with lab operations and functions Physical Demands and Work Environment:

Ability to sit at a desk for extended periods of time

Ability to stand and walk for extended periods of time

Occasional lifting (5-50lbs)

Speaking and hearing abilities to understand and communicate with employees and external parties

Bending, kneeling, and other odd body positions while performing job duties on and around equipment

Manual dexterity to operate general office equipment and a computer for extended periods of time

Good eyesight to tolerate extended viewing of computer screen. Able to read, interpret, and create business documents and communications GENERAL INFORMATION:

The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.