Senior Scientist - Pharmaceutical, Te...
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Jul
12
Sandeep Singh Dhillon
Senior Scientist – Pharmaceutical, Technical Transfer
Pharma Job Portal
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Astrix Technology Group

About the Job

Senior Scientist

Location: Wilmington, DE

CRITICAL CRITERIA
Must have Pharma background and oral solid dose experience
Experience with transferring product manufacturing internationally
Proficient with pulling and analyzing data

Description
The Senior Scientist role is responsible for aiding in the supply of strategic drug product technical expertise and support to a portfolio of established products
The products are manufactured either internally at a company manufacturing site or externally at a contractor
The technical expertise and support is used in problem solving as well as in continuous improvement activities
This a great opportunity to learn about the company’s exciting and diverse established product portfolio and to gain experience working in a Global function and with external suppliers

Responsibilities
Support License to Operate activities
Provide technical expertise and problem-solving support to the manufacturing sites
Provide technical expertise and support in creating regulatory documentation and responses to regulatory questions in a way that ensures maximum flexibility for Operations
Support manufacturing and supply chain changes
Perform technical risk assessments for proposed changes, e.g. to excipients, packaging/device components, manufacturing processes and/or analytical testing methods
Propose experimental work to support changes
Review generated data and make recommendations on whether to proceed with changes or not
Maintain product knowledge
Write reports and memos to record technical investigations or recommendations, ensuring data integrity
Contribute to and/or coordinate Quality Risk Assessments and Technical Opportunity and Risk Assessments (TORAs) as required
Produce and maintain information in the Product Knowledge Management tool
Coordinate, lead or support product improvement initiatives
As required, ensure delivery of product and process improvements that will deliver business benefits
Develop or support the manufacturing sites in developing business cases
Co-ordinate appropriate support teams if required
Maintain communication to product stakeholders
Work with Product Champions to receive work requests, perform priority assessments and agree level of effort on each activity
Establish networks between sites who manufacture the same or similar products to ensure effective collaboration
Effectively communicate product performance and product issues to the manufacturing sites
Build technical understanding and capability
Train manufacturing sites in, e.g. pharmaceutical technologies, formulation and packaging design, manufacturing and testing control strategies and analytical techniques as appropriate

Minimum Requirements
BS degree in a relevant discipline, e.g. analytical chemistry, chemical engineering or pharmaceutics
Preferred: Master’s Degree or PhD in a relevant discipline, e.g. analytical chemistry, chemical engineering or pharmaceutics
Experience of pharmaceutical manufacturing/QC testing and/or research and development
Knowledge of the overall drug development and commercialization process from development, launch and through life cycle management
Experience working in one of the following disciplines: Analytical Science, Chemical Science, Formulation Science, Physical Science, Pharmaceutical Manufacturing and Supply Chain Management
Knowledge of international GMP and SHE requirements and their applicability to pharmaceutical manufacturing, research, and development
Knowledge of Quality Management Systems and their applicability to pharmaceutical manufacturing
Experience working in Global function and/or with external parties

Skills & Capabilities
Business awareness – knowledge of company; its policies, organization, and culture, established products and development pipeline
Strong ability to work both independently and collaboratively across boundaries- cross-functionally, cross-culturally
Strong conceptual and strategic thinking skills
Good flexibility and change enablement capabilities
Good business relationship management and influencing skills
Good project and portfolio management skills
Ability to cascade knowledge through training and education

For interested candidates, please apply at

http://job-openings.monster.com/Senior-Scientist-Pharmaceutical-Technical-Transfer-Wilmington-DE-US-Astrix-Technology-Group/11/186100861?MESCOID=1900254001001&jobPosition=7



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