- Work in a GMP laboratory performing method validations and transfers.
- Perform HPLC, Dissolution, method validation, method transfer, and change control tasks as needed.
- Assist in laboratory investigations at commercial sites; method troubleshooting.
- Data review and analysis
- Author commercial methods into organization systems
- Initiate and manage analytical test method change controls
- Support documentation change activities within Pharma Analytical Sciences group
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- AND 4+ years of experience that provides the knowledge, skills, and abilities to perform the job.
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. - Solid understanding and knowledge of general chemistry and separation science
- Experience in a regulated GMP lab.
- Experience using QMS system such as Infinity to manage change controls
- Experience with separations techniques (HPLC, UPLC, GC, etc.)
- Experience with dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.
- Experience in reviewing data for accuracy, compliance, and completeness.
- Experience with Empower or equivalent chromatographic integration software
- Experience with ELN and/or LIMS systems is a plus
- Familiar writing technical reports
- Proficiency on technical operating systems
- Proven problem solving and troubleshooting abilities
- Effective oral and written communication skills
- Ability to work in a collaborative work environment with a team
- 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.
- As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
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Senior Scientist - Summit, United States - Thermo Fisher Scientific
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 leverage 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.
Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once your become a part of the Thermo Fisher's Clinical Research Group team.
To learn how Thermo Fisher's Clinical Research Group can advance your career, apply now
A day in the Life:
As a Senior Scientist, you will work in an analytical team supporting the entire commercial, small product portfolio. The position will be a blend of analytical chemistry lab work and administrative duties. The essential duties and responsibilities include, but are not limited to, the following:
Education and Experience:
Knowledge, Skills and Abilities:
Working Environment:
Thermo Fisher Scientific Clinical Research Group values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Our 4i Values:
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.
