Job Description
Role: Scientist, Formulations
This is a fully onsite role based at our customer’s site in Collegeville, PA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
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 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
Key Responsibilities:
- 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 with 2-4 years of experience in an appropriate subject area
- 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. _
Working Conditions and Environment:
- Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
- Occasional drives to site locations, occasional domestic travel.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions.
Physical Requirements:
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
- Occasional mobility needed.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued
