Scientist/Sr. Scientist

MedPharm•Durham, NC

21h

About The Position

Act as a lead analytical scientist on assigned studies. Assist with study plan review, sample preparation, chromatographic analysis, data processing and interpretation, and report writing. To perform experiments, ensuring that projects are completed to plan, while complying with all quality and safety regulations.

Requirements

Bachelor’s degree (4 years)
No required certifications.
5 up to 7 years of work experience.
Must be experienced in HPLC sample analysis and method validation.
Understanding of analytical separation techniques, including reverse-phase, ion exchange, and HILIC.
Comfort working with both large and small molecules
Familiarity with FDA and ICH guidelines for bioanalytical work
Must have a meticulous approach to work and be highly organized.
Good communication skills, both written and oral.
Comfortable presenting technical information and addressing technical questions.
Must be able to multitask, manage time efficiently and be able to prioritize.
Must be able to work independently and in a team environment.
Read and comprehend simple instructions, short correspondence and memos. Write simple correspondence. Effectively present information in one-on-one and small group situations to customers, clients and other employees.
Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.
Microsoft Office (Word, Excel, PowerPoint, Access, Publisher, Outlook, Internet Explorer)

Nice To Haves

Experience in HPLC method development is desirable.
Experience with developing stability indicating methods is desired.
Experience with Waters Empower or Shimadzu LabSolutions is preferred

Responsibilities

Perform chromatographic analyses to support performance testing and bioanalytical activities such as permeation and penetration studies, release investigations, extractions, stability studies and regulated sample analysis.
Develop ‘fit for purpose’ methods for the analysis of in vitro samples in support of Sponsor R&D projects; Show proficiency in U/HPLC use, troubleshooting and maintenance.
Validation of analytical methods according to the appropriate regulatory guidance.
Support the implementation and growth of the formulation development group at MedPharm US by analyzing pre-formulation and solvent system stability samples (experience with developing stability indicating methods is desired).
Lead and work effectively in small cross-functional teams; Provide technical expertise to analytical group in addition to other internal teams
To promptly record all data using Good Documentation Practices as per MedPharm US procedures.
Report any amendments or deviations from study plans/ testing protocols to the Study Manager/ Management as appropriate.
Serve as technical support in root cause failure analysis
Confer with scientists to conduct analyses of research projects, interpret test results, or develop nonstandard tests as needed.
Prepare test solutions, compounds, or reagents for laboratory personnel to conduct tests.
Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed.
To adhere to MedPharm’s procedure and guidance documents.
To adhere to MedPharm Health & Safety Policy and OSHA regulations at all times and to ensure the safety of others in any procedures or tasks performed.
Any other duties and/or tasks that may be assigned.