MedPharm · 1 day ago
Scientist/Senior Scientist- Bioanalytical
Durham, NC
Full-time
Onsite
Mid, Senior Level
5+ years expMedPharm is a global leader in topical and transdermal product development, providing end-to-end services from early-stage formulation development to full commercial production. The Scientist/Senior Scientist in Bioanalytical will act as a lead analytical scientist, performing chromatographic analyses and supporting performance testing and bioanalytical activities while ensuring compliance with quality and safety regulations.
BiotechnologyDeveloper PlatformManufacturingPharmaceutical
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
Qualification
Required
Bachelor's degree (4 years)
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)
Preferred
Experience in HPLC method development is desirable
Experience with Waters Empower or Shimadzu LabSolutions is preferred
Company
MedPharm
MedPharm is a world-leading contract provider of topical and transdermal product design and development services.
51-200 employees
H1B Sponsorship
MedPharm has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (3)
2022 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Ampersand Capital Partners
2024-07-08Acquired
2018-03-26Series Unknown
Recent News
2026-01-09
2024-11-25
Company data provided by crunchbase