Scientist I - Pharmaceutical Drug Development

Job DescriptionJob 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:

• Perform necessary literature and patent search to support studies for development of drug products and generate data/development reports for use by the sponsors as part of their regulatory submissions or patent filings.
• Plan and perform various stages of product development studies, including pre-formulation, formulation development, process development, optimization, and technology transfer.
• Incorporate Quality-by-Design tools in drug development. Develop prototype formula and evaluate the predetermined QTPPs and CQAs.
• Write and review GMP documentation, including manufacturing batch records, and appropriate study protocols, and interface with CTM Manufacturing Team for technology transfer for CTM Batch Manufacturing.
• Collaborate with team members (Analytical Scientists, Quality Assurance, Material Coordinator, and Manufacturing Technicians) to meet timelines for drug product delivery.
• Assist department supervisor in collaborating with sponsor(s) to facilitate transfer of knowledge and deliverables of drug product.
• Follow company policies and conduct work according to appropriate Frontage SOPs and comply with cGMP guidelines.

Requirements:

• MS in Pharmaceutics, Pharmaceutical Science or related field with 1-3 years of experience.
• In depth knowledge of theory and techniques in drug development and drug delivery.
• Experience in sterile product development including emulsions, suspensions, and lipid-based delivery systems. cGMP knowledge and hands-on experience in sterile small molecule and Protein/biologics product development is a plus.
• Strong written, and verbal communication, and presentation skills.
• Good understanding cGMP, Regulatory Compliance including FDA/EU/ICH guidance with regards to drug development.

Salary and Benefits:

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

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to , , , , , , , , status as a protected veteran, among other things, or status as a qualified individual with .