Associate Scientist / Scientist - HPLC , cGMP , Quality
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 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
The Analytical Research and Development (ARD) group for new chemical entities (NCEs) supports development of solid oral dosage forms from First in Human (FIH) clinical studies up to commercialization, using common to state-of-the-art analytical technologies while maintaining Good Laboratory Practices (GLP/GxP).
In this position you will primarily support routine testing of NCEs, with potentially some opportunities for analytical method development/validation. The candidate will assist with basic and novel experimental approaches to answer scientific questions with the overall goal of developing and optimizing NCE drug product formulations. Working closely with analytical and formulation scientists, you will develop productive collaborations and communications both within and across various scientific teams.
Major Responsibilities
- Analytical characterization and assessment of clinical trial supplies (e.g. GMP compliant stability and release testing for both drug substances and drug products)
- Review and approve data of other scientists
- Understand and adhere to corporate standards regarding code of conduct, safety, and GxP compliance.
- Responsible for compliance with all applicable client policies and procedures.
- Documents experimental data appropriately in laboratory documentation system and technical memos.
- Maintains laboratory equipment and optimize laboratory operations for safe and efficient use of time and resources.
- Troubleshoots equipment and experimental problems.
- Assists in continuous improvement activities.
- Willingness to learn new analytical techniques as opportunities arise.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
#LI-KP2
Education and Experience:
Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Associate Scientist: 0-2 years experience
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.
Knowledge, Skills and Abilities:
Experience in analytical methodology, such as chromatography (HPLC/GC/IC), KF, UV and common compendial methods required.
Experience in specialty techniques desired (LCMS, GCMS, PXRD, ICP, Dissolution, Disintegration)
At least one year in a regulated GMP lab.
Experienced in laboratory systems (LIMS, CDS, ELN) required.
Experience in Microsoft Office (Excel, Power Point, and Word) required.
Proven ability to interpret data by performing trend analysis
Proven ability in technical writing skills
Ability to independently optimize analytical methods
Proven problem solving and troubleshooting abilities
Good written and oral communication skills
Time management and project management skills
Ability to work in a collaborative work environment with a team
PPD, part of Thermo Fisher Scientific values the health and well-being 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:
- 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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