Coppell, TX 75019
$24 per hour
6-12 month Contract
As the Associate Scientist
, you will be responsible for providing expert technical support to a newly approved drug that is manufactured internally on site. This role is ideal for scientists whose subject matter expertise is derived in inorganic chemistry, analytical sciences, process engineering & material science.Responsibilities:
- Aid in the resolution of manufacturing/analytical method/process issues & complaints impacting supply or manufacturability.
- Provide input to the development of suitable corrective and preventive actions in support of investigations.
- Support product supply strategy projects (sourcing, asset transfers, capacity expansion etc) and business continuity plans through delivery of the drug substance control, manufacturability strategy and product quality risk management activities throughout the lifecycle.
- Support a prioritized portfolio of project activities.
- Provide technical support during the transfer of established products within the site (eg new manufacturing trains/scales including support for equivalency determination as applicable.
- Support complex technical improvements or change activities assuring API performance.
- Support for drug substance process validation programs in the support of transfer and change activities.
- Management of product knowledge throughout the lifecycle.
- Provide support to product, and/or method lifecycle activities to ensure equivalence across sites eg integrated product reviews, specifications, methods, processes.
- Provides input for process trending including investigation of out of trends.
- Maintain technical knowledge in area of subject matter expertise including up to date advances in new technologies to aid in the improvement of manufacturing processes and or methods.
- BSc/BEng or PhD level in an appropriate discipline.
- 2-3 years’ experience in a similar role/environment.
- Knowledgeable of the overall drug development and commercialization process from development, launch and through life cycle management
- Must have a deep understanding of their discipline, such as, inorganic chemistry, analytical, process engineering or material science.
- Knowledge of principles, applications and management of SHE and cGMP.
- Evidence of good communication skills.
- Build effective networks within the local site teams.
- Ensure that all work is carried out in compliance with client company and external regulatory policies and standards.
- Develop scientific solutions to problems related to their discipline.
- Develop proficiency to consider risk management within own area of work.
- Good communication skills and interpersonal skills in order to collaborate effectively with stakeholders and customers.
Please submit your resume for consideration!