Posted: 8 March
Offer description
About PPD
At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
Our Work
Clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital and decentralized clinical trial services.
Your Impact
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Job Description
The role of Associate Research Scientist is responsible for the regulatory and scientific conduct of development and stability projects in the Biopharmaceutical Laboratory.
A Day in the Life:
* Independently performs analytical testing, method optimization/validation, and/or other specialist technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems.
* Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
* Communicates data and technical issues to clients on a weekly basis (or as needed).
* Provides technical mentorship and training to staff.
* Learns analytical (procedural and instrumental) troubleshooting sessions.
* Assists in preparation and implementation of SOPs and quality systems.
* Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP).
Education and Experience
* Degree or equivalent in Chemistry or Biochemistry.
* In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
Knowledge, Skills, Abilities
* Knowledge of general chemistry, biochemistry techniques (SDS-PAGE, Western Blot, total protein by BCA or micro BCA assay, ELISA, Cell based Assay)
* Proven experience of method development of identity and purity assays
* Ideally experience in leading CMC studies for biopharmaceutical products including method validation
* Proficiency on technical operating systems (including Image Lab software)
* Proven problem solving and troubleshooting abilities
* Ability to independently perform root cause analysis for method investigations
* Proven ability in technical writing skills
* Time management and project management skills
* Good written and oral communication skills
* Ability to work in a collaborative work environment with a team
* Ability to train junior staff
Work Environment
* Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
* Able to work upright and stationary and/or standing for typical working hours.
* Able to lift and move objects up to 25 pounds.
* Able to work in non-traditional work environments.
* Able to use and learn standard office equipment and technology with proficiency.
* May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
* Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
