MedPharm · 3 weeks ago
Scientist III, Analytical R/D
Durham, NC
Full-time
Onsite
Senior Level
6+ years expMedPharm is seeking a Scientist III/Sr. Scientist responsible for developing and validating analytical methods to support drug formulation development in a GMP-compliant laboratory. The role involves project management, performing validations, stability testing, and mentoring junior scientists while ensuring data integrity and regulatory compliance.
BiotechnologyDeveloper PlatformManufacturingPharmaceutical
Responsibilities
Develop and validate analytical methods to support formulation drug development under minimal supervision
Perform routine testing including stability testing, solubility studies, and Drug-Excipient Compatibility studies as and when needed
Ability to own projects independently including literature review, material sourcing, design experiments, executing/delegating tasks and providing data to customers
Perform forced degradation studies
Author product development reports and investigation reports
Author/ Co-author analytical methods, validation and transfer protocols, instrument qualification protocols, validation/qualification reports, SOPs, etc
Execute routine instrument troubleshooting, peer review of laboratory notebooks, maintenance of logbooks
Maintain laboratory equipment, including calibration scheduling, acquisition, and basic maintenance programs
Maintain a GMP-compliant analytical laboratory and safe working environment, maintain lab inventory
Review laboratory notebooks, data packs, and reports under minimal supervision. Trend stability data
Present data to the customers, attend client meetings as needed under minimal guidance
Supervise, mentor, train and develop junior scientists
Qualification
Required
B.S., with 8+ years', M.S., with 6+ years' experience, Ph.D.: focus in chemistry, biology, pharmaceutics
4+ years' experience in a GMP laboratory setting
Proven track record developing and validating GMP-compliant HPLC and GC methods to assess drug product stability
Experience diagnosing and troubleshooting HPLC instrumentation, and addressing OOS and OOT results
Experience with the operation of HPLC and GC
Knowledge of cGMP regulations and ICH, USP, and FDA guidelines
Speaks, writes, listens, and presents information in a logical and articulate manner appropriate for the audience
Thorough when performing work, conscientious about attending to detail, and uses logical thinking that is well-organized and methodical
Preferred
Experience developing methods for topical drug products is a plus
Experience with Empower 3 software
Experience with UV, FTIR, KF, optical microscopy, PSD, viscosity, and rheological methodology a plus
Technical report writing proficiency preferred
Experience with software such as MasterControl and MS Office 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