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Patheon
Sr. Principal Scientist
Greenville, NC - USA
Posted December 15, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary

The Continuous Manufacturing – Sr. Principal Scientist will be a part of a team of technical professionals dedicated to develope continuous manufacturing methodologies to support Patheon’s drug product development pipeline from formulation development up through commercial launch and supply.

 Experience in the application of continuous manufacturing processes for solid dosage manufacture is required. This position is primarily responsible for operating, optimizing, and providing technical troubleshooting support of the solid dosage continuous manufacturing platform.

 The selected candidate will have a solid background in process engineering and how it applies to pharmaceutical process development and design. Specifically, experience in compression, granulation and coating is rquired. In addition to hands on experience they must also have a strong background in data analysis and process modeling. Data analysis methods could include multivariate analysis techniques such a PLS and PCA. Modeling methods could include FEM, CFD and DEM. Modeling method should also include some experience with semi-empirical models.

 The candidate will interface with PDS, Engineering, Operations, Quality, and Validation departments in support of development projects to provide optimal continuous manufacturing processes.

Key Requirements

1.       Develop, technology transfer, and optimize continuous manufacturing processes for new solid dosage products and formulations.

2.       Drive fundamental understanding of unit operations through experimental investigation and modeling.

3.       Perform advanced data analysis, process model development, and apply findings to the continuous processing platform

4.       Execute scientific studies and designed experiments in the optimization and control of process unit operations and applying learnings to the continuous manufacturing platform

5.       Identify implementation opportunities and strategies for the transfer of existing batch processes to continuous manufacturing.

6.       Provide expertise in the selection, application, and optimization and troubleshooting real-time analytics (RTA) to support drug product continuous manufacturing platform.

7.       Support the creation, maintenance, update, modification and lifecycle of in-line and at-line real time analytics models.

8.       Evaluate, recommend, and liaise with industry and academic collaborative groups engaged in pharmaceutical continuous manufacturing.

9.       May act as project manager for continuous manufacturing related projects

10.    Define aspects of project scope and use project management skills to schedule, track progress, and make adjustments to project timelines

11.    Develop budgetary and schedule estimates for the requirements of projects

12.    Communicate project requirements to vendors to obtain proposals for equipment installation of continuous manufacturing equipment

13.    Write technical reports and/or presentations relevant to drug product continuous processing activities and present to various levels of management

Qualifications

Education:

Masters or PhD degree in chemical/mechanical/pharmaceutical engineering/science or related field

 Experience:

1.       PhD and 2+ years of productive, relevant work or postdoctoral experience or MS and 5+ years of productive, relevant work experience

2.       Applied experience in modern control theory, process modeling, and systems optimization.

3.       Experience with mathematical modeling and optimization software to solve practical problems.

4.       Experience with implementation of industrial model-based process control & optimization is required.

 

Equivalency:

 Equivalent combinations of education, training, and relevant work experience may be considered.

 Competencies: 

1.       Experience with Matlab is strongly recommended.

2.       Applied understanding of statistical principles like PCA/PLS, correlation and regression analysis as it applies to continuous pharmaceutical manufacturing processes

3.       Proficient knowledge of FDA regulatory requirements.

4.       Able to write detailed technical reports.

5.       Able to effectively present detailed technical information and respond to technical questions.

6.       Knowledge of pharmaceutical business processes and equipment.

7.       Able to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data.

 Physical Requirements:

 Disclaimer: 

This job description is intended to present the general content and requirements for the performance of this job.  The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

 Nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 
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