JOB DESCRIPTION

Job Description
Thermo Fisher’s clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
As a Research Scientist supporting the Pharm Dev Steriles in our client’s Pharmaceutical R&D, you will have the opportunity to apply technical skills and expertise to develop drug product formulations and associated manufacturing processes as part of a matrix technical team. You will also use creative thinking to drive drug development of a variety of sterile product dosage forms
This role will be onsite in : Collegeville, PA

Key Responsibilities: List activities that comprise the job including aspects of budget control, people management, technical activities, health & safety, GMP and individual specific activities.

• Completes pre-formulation, formulation and process development activities based on established protocols and procedures
• Assists in the manufacture of batches of product as required, e.g. for process development, stability studies or clinical trials
• Coordinates activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project results
• Works with the team to align and implement pre-formulation, formulation and process development activities including authoring or contributing to manufacturing batch records
• Identify and begin to interpret any problems in the execution of experimental processes and/or in results and communicates them to supervisor
• Proactively engage and seek assistance from other scientists to solve problems
• Maintains cleanliness in own work area and in communal work areas
• Anticipates/recognizes potential problems with equipment and/or supplies, and proposes/initiates action to solve or prevent problems
• Operates equipment for which is trained independently with due regard for GMP and Safety
• Demonstrates timely & reliable recording of laboratory data in Labware and other suitable systems in accordance with company policy and legal requirements.
• Performs data management tasks including recording results successfully and in compliance with departmental guidelines in a laboratory notebook or computer (e.g. tabulating and graphing results)
• Consults with supervisor when difficulties arise that cannot be readily resolved
• Prepares oral or written summaries of results with interpretation for project work
• Writes specific technical sections of internal and external reports with supervision
• Attends regular safety training and is fully aware of safety requirements for their laboratory/working environment
• Maintains accurate and complete safety records consistent with company policy and legal requirements
• Recognizes potential safety problems and takes action to resolve them

BASIC REQUIREMENTS:

• BS degree and 2-4 years of experience in an appropriate subject area or a MS with 0-2 years of experience.
• ARS Level experience needed: BS, 6-8; MS, 4-6; PhD, 2-4
• Is technically proficient in a number of formulation/process development techniques.
• Has good knowledge of GMP and GLP requirements, SOPs and policies
• Has operational knowledge of routine laboratory/plant equipment
  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.

• Completes pre-formulation, formulation and process development activities based on established protocols and procedures
• Assists in the manufacture of batches of product as required, e.g. for process development, stability studies or clinical trials
• Coordinates activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project results
• Works with the team to align and implement pre-formulation, formulation and process development activities including authoring or contributing to manufacturing batch records
• Identify and begin to interpret any problems in the execution of experimental processes and/or in results and communicates them to supervisor
• Proactively engage and seek assistance from other scientists to solve problems
• Maintains cleanliness in own work area and in communal work areas
• Anticipates/recognizes potential problems with equipment and/or supplies, and proposes/initiates action to solve or prevent problems
• Operates equipment for which is trained independently with due regard for GMP and Safety
• Demonstrates timely & reliable recording of laboratory data in Labware and other suitable systems in accordance with company policy and legal requirements.
• Performs data management tasks including recording results successfully and in compliance with departmental guidelines in a laboratory notebook or computer (e.g. tabulating and graphing results)
• Consults with supervisor when difficulties arise that cannot be readily resolved
• Prepares oral or written summaries of results with interpretation for project work
• Writes specific technical sections of internal and external reports with supervision
• Attends regular safety training and is fully aware of safety requirements for their laboratory/working environment
• Maintains accurate and complete safety records consistent with company policy and legal requirements
• Recognizes potential safety problems and takes action to resolve the