Senior Scientist

US Tech Solutions; Wilmington (DE); Vor Ort; USD 80.000 - 120.000; Vollzeit

Zusammenfassung

A global staff augmentation firm is seeking a Senior Scientist to provide strategic drug product technical expertise and support for established products. This role involves problem-solving, technical risk assessments, and maintaining communications with stakeholders. Applicants should have a BSc in a relevant field, experience in pharmaceutical manufacturing or R&D, and knowledge of regulatory documentation. This is an excellent opportunity to gain experience in a dynamic and global environment.

Qualifikationen

• BSc in analytical chemistry, chemical engineering, or pharmaceutics required.
• Experience in pharmaceutical manufacturing/QC testing or R&D needed.
• Knowledge of drug development and commercialization processes essential.

Aufgaben

• Provide technical expertise to manufacturing sites.
• Perform technical risk assessments for proposed manufacturing changes.
• Write reports to document technical investigations and recommendations.

Kenntnisse

Analytical chemistry

Chemical engineering

Pharmaceutical manufacturing

Problem solving

Regulatory documentation

Quality Management Systems

Ausbildung

BSc degree in a relevant discipline

Masters Degree or PhD in a relevant discipline

Jobbeschreibung

US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website www.ustechsolutions.com.

We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, set the correct expectation and thus become an accelerator in the mutual growth of the individual and the organization as well. Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset.

Job 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 CLIENT’S 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 is a great opportunity to learn about CLIENT’S’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.

• 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.

Qualifications

Minimum Requirements - Education and Experience (Required)

• BSc degree 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

Qualifications

Minimum Requirements - Education and Experience (Desired)

• Masters Degree or PhD in a relevant discipline, e.g. analytical chemistry, chemical engineering or pharmaceutics
• Experience working in Global function and/or with external parties
• Experience working in more than one area of the overall drug development and commercialization process from development, launch and through life cycle management
• Experience working in two or more disciplines such as Analytical Science, Chemical Science, Formulation Science, Physical Science, Pharmaceutical Manufacturing and Supply Chain Management
• Extensive knowledge of international GMP and SHE requirements and their applicability to pharmaceutical manufacturing, research and development
• Extensive knowledge of Quality Management Systems and their applicability to pharmaceutical