Scientist III, Analytical R&D

MedPharm Ltd; Durham (NC); Hybrid; USD 95,000 - 145,000; Full time

Job summary

MedPharm Ltd. seeks an experienced Scientist III/Senior Scientist to develop and validate analytical methods supporting drug formulation development in a GMP laboratory. You will manage projects end-to-end, perform stability studies, write validation protocols, and troubleshoot HPLC/GC instruments while ensuring data integrity.

You will collaborate with Formulation R&D, Quality Control, and Quality Assurance, mentor junior scientists, and maintain a compliant lab environment. Travel is minimal.

Qualifications

• B.S. or higher in chemistry/related field with strong GMP exposure.
• Experience in developing and validating GMP-compliant HPLC/GC methods.
• Proven ability to lead projects and mentor junior scientists.

Responsibilities

• Develop and validate analytical methods to support formulation drug development under minimal supervision.
• Perform routine testing including stability testing and solubility studies.
• Own projects independently from literature review to data delivery.
• Author/validate protocols, development reports, and SOPs.
• Troubleshoot HPLC and GC instrumentation and address OOS/OOT results.
• Mentor and develop junior scientists; present data to customers.

Skills

Method validation

HPLC troubleshooting

GC troubleshooting

Regulatory compliance

Mentoring

Literature reviews

Education

B.S. in Chemistry

M.S. in Chemistry

Ph.D. in Chemistry/Biology/Pharmaceutics

Tools

HPLC

GC

Empower 3 software

MasterControl

Job description

Position Summary

The Scientist III/ Sr. Scientist is responsible for developing and validating analytical methods to support drug formulation development in a GMP-compliant laboratory. This role involves performing validations, stability testing, and forced degradation studies while ensuring data integrity and regulatory compliance. The scientist will independently manage projects, including literature reviews, experimental design, execution, and reporting. Responsibilities also include authoring technical documents such as method validation protocols, development reports, and SOPs, as well as troubleshooting analytical instrumentation like HPLC and GC. Additionally, the role requires mentoring junior scientists, collaborating with cross-functional teams such as Formulation R&D, Quality Control, and Quality Assurance, and maintaining a safe, well-organized laboratory environment.

Essential Functions

• 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

Supervisory responsibilities:

Direct Reports: No
Indirect Reports: Yes

Key Relationships (examples: Depts or Individual positions that this position will be working closely with):

• Process Development/ Formulation R&D
• Quality Control
• Quality Assurance

Travel requirements: N/A

Education and Experience

• 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 developing methods for topical drug products is a plusli>
• Experience diagnosing and troubleshooting HPLC instrumentation, and addressing OOS and OOT results
• Experience with the operation of HPLC and GC
• Experience with Empower 3 software
• Experience with UV, FTIR, KF, optical microscopy, PSD, viscosity, and rheological methodology a plus

Knowledge, Skills, and Abilities

• 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
• Technical report writing proficiency preferred
• Experience with software such as Master Control and MS Office preferred
• Thorough when performing work, conscientious about attending to detail, and uses logical thinking that is well-organized and methodical

Physical Demands and Work Environment

While performing the duties of this job, there may be certain physical demands required for the position.

• Occasionally required to lift/carry up to 20lbs
• Requires standing/walking for extended periods in a climate-controlled lab environment
• Frequent bending, lifting, pushing, pulling, carrying, and sitting may be required
• May be exposed to moderate noise levels in a climate-controlled lab environment

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.