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21 Oct 2022

Full-Time Formulation Scientist (Scientific Leader/Associate Director) – Injectable Products

gloriana.h.hidalgo@gsk.com – Posted by gloriana.h.hidalgo@gsk.com Montgomery County, Pennsylvania, United States

Job Description

As a Formulation Product Development Scientific Leader/Associate Director, you will contribute to the development of the company’s products. You will also participate in international product teams to define and implement development policy and programs that best support the product strategy and future positioning of the organization.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include the following:

  • Member of a team responsible for enabling the progression of NCE’s from candidate selection to product commercialization.
  • Leading drug product development matrix teams supporting product development.
  • Progress drug product design & development aspects of projects, utilizing experience and expertise as part of a Product Development &Supply technical matrix team and wider matrix teams.
  • Exercise professional judgment to determine the most appropriate course of action for a project.
  • Leads or contributes to Pharmaceutical Development strategies.
  • Develop phase appropriate formulations to support clinical studies and ultimately commercialization.
  • Develop and optimize processes for the manufacture of drug products and participate in manufacturing of clinical supplies.
  • Design and execute DOE, scale up studies, and participate in technology transfer.
  • Prepare development reports and participate in preparing regulatory documents.
  • Propose and deliver innovative approaches to achieve project goals.
  • Lead technical risk assessments (FMEA) and control strategy development.

 

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

·        PhD in Pharmaceutics, Chemical Engineering, or other related fields with a minimum of 5 yrs of industrial experience in pharmaceutical development.

 

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Experience in formulation and process development of small molecules, particularly novel complex injectable products, e.g. long acting injectables, liposomes, etc.
  • Experience in developing phase appropriate formulations and manufacturing processes for small molecules.
  • Experience in authoring drug product modules of new drug applications and marketing authorization applications is preferred.
  • Good understanding of physico-chemical properties and biopharmaceutics is desired.
  • Expertise in sterilization techniques is preferred.
  • Experience in working within a product development matrix team.
  • Experience in leading a product development matrix team is preferred.
  • Demonstrates strong networking skills through interactions across departments, divisions, and disciplines
  • Familiar with cGMP and regulatory requirements for manufacturing operations and documentation.
  • Good oral and written communication skills.
  • Experience with technical risk assessments (FMEA) and control strategy development.
  • Good knowledge of QbD as presented in regulatory dossiers
  • Experience conducting root cause analyses and investigations

How to Apply

Formulation Scientist (Scientific Leader/Associate Director) – Injectable Products (myworkdayjobs.com)

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: Not Disclosed.

Job expires in 50 days.

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