Analytical Scientist: HPLC Method Developer

Actalent; Cranbury Township (NJ); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan – Pre-tax and R

Life Insurance (Voluntary Life & AD&D)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick)

Job summary

Actalent is seeking an Analytical Scientist in East Windsor, NJ to support R&D by conducting tests and developing/validating analytical methods, including HPLC-based cleaning verification. The role includes routine and non-routine analyses, data documentation, and collaboration with Quality and Operations in a fast-paced pharmaceutical setting.

The ideal candidate holds a Bachelor's in Chemistry with 3+ years in analytical labs, strong USP/EP knowledge, and excellent communication skills.

Qualifications

• Bachelor's degree in Chemistry or relevant field with 3+ years in analytical lab.
• Experience in analytical method development, validation, and transfer.
• Experience operating HPLC in a pharmaceutical lab.
• Familiarity with cGMPs, EU, 21 CFR Parts 210, 211, 820, ISO and ICH guidelines.
• Strong knowledge of USP, EP and pharmacopeia.
• Experience in dissolution or aerosol testing.
• Excellent written and verbal communication.
• Proficient with MS Office.
• Ability to read SOPs and analytical methods.
• Legible handwriting.

Responsibilities

• Support Analytical Laboratory Services in development and maintenance of procedures.
• Perform analyses to evaluate quality of raw materials, in-process materials, and finished goods.
• Develop, conduct, and validate chemical assays.
• Develop, evaluate, and validate analytical methods for cleaning verification via HPLC.
• Collect and analyze routine equipment cleaning verification/validation samples.
• Document data from analytical tests in notebooks, worksheets, or batch records.
• Peer-review laboratory records.
• Communicate quality or compliance concerns to Line Manager and Senior Management.
• Support OOS/OOT investigations and communicate findings per SOPs.
• Support environmental monitoring activities as required.
• Comply with SOPs, cGMPs, and regulatory standards.
• Perform other duties as assigned.

Skills

Analytical Method Development

Method Validation

Transfer/Verification

USP/EP Knowledge

Communication Skills

SOP Reading/Interpretation

Microsoft Office

Dissolution Testing

Aerosol Testing

Legible Handwriting

Education

Bachelor's Degree in Chemistry

Tools

HPLC

Equipment Troubleshooting

Job description

Actalent is seeking an Analytical Scientist in East Windsor, NJ to support R&D by conducting tests and developing/validating analytical methods, including HPLC-based cleaning verification. The role includes routine and non-routine analyses, data documentation, and collaboration with Quality and Operations in a fast-paced pharmaceutical setting.

The ideal candidate holds a Bachelor's in Chemistry with 3+ years in analytical labs, strong USP/EP knowledge, and excellent communication skills.