Scientist III, Analytical R&D

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 plus

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.