Scientist I - Pharmaceutical Drug Development

ZipRecruiter; Exton (Chester County); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in pharmaceutical drug development is seeking a Scientist I to join their team in Exton, PA. The role involves conducting drug development studies, planning product development stages, and ensuring compliance with regulatory standards. The ideal candidate will have a Master's degree in a relevant field and experience in sterile product development. This position offers a competitive salary and benefits package, including health insurance and a 401(k) plan.

Benefits

Health Insurance

Dental Insurance

401(k) Plan

Life Insurance

Qualifications

• 1-3 years of experience in drug development.
• Deep knowledge of drug development theory and techniques.

Responsibilities

• Perform literature and patent searches for drug development.
• Plan and execute product development stages.
• Write and review GMP documentation.

Skills

Communication

Presentation

Writing

Education

MS in Pharmaceutics

Pharmaceutical Science

Job description

Job Description

Scientist I, Pharmaceutical Drug Development

Title: Scientist I

Location: Exton, PA (CMC)

Full time

Frontage Laboratories Inc. is an award-winning, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China. Our core competencies include drug metabolism, pharmacokinetics/pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Responsibilities:

1. Perform literature and patent searches to support drug development studies and generate data/development reports for regulatory submissions or patent filings.
2. Plan and execute various stages of product development, including pre-formulation, formulation development, process development, optimization, and technology transfer.
3. Incorporate Quality-by-Design tools in drug development, develop prototype formulas, and evaluate QTPPs and CQAs.
4. Write and review GMP documentation, including manufacturing batch records and study protocols, and coordinate with the CTM Manufacturing Team for technology transfer and batch manufacturing.
5. Collaborate with analytical scientists, QA, material coordinators, and manufacturing technicians to meet drug product delivery timelines.
6. Assist supervisors in coordinating with sponsors to facilitate knowledge transfer and deliverables of drug products.
7. Adhere to company policies, SOPs, and cGMP guidelines.

Requirements:

• MS in Pharmaceutics, Pharmaceutical Science, or related field with 1-3 years of experience.
• Deep knowledge of drug development theory and techniques.
• Experience in sterile product development, including emulsions, suspensions, and lipid-based systems. cGMP experience and hands-on work with sterile small molecules and biologics are a plus.
• Strong communication, presentation, and writing skills.
• Understanding of cGMP, regulatory compliance, and FDA/EU/ICH guidance related to drug development.

Salary and Benefits:

Frontage Laboratories offers a competitive compensation and benefits package, including health and dental insurance, a 401(k) plan, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, disability, or protected veteran status.