Lead Formulation Development Scientist (Clinical)

PTC Therapeutics, Inc.; Bridgewater (MA); On-site; USD 191,000 - 240,000; Full time

Job summary

PTC Therapeutics, Inc. seeks a Senior Research Fellow, Formulation Development to lead formulation development and clinical supply manufacturing for Phase I–III programs, covering preclinical formulation design, preformulation characterization, process development and tech transfers.

The role manages internal and external resources, drives timely development and manufacture of phase-appropriate formulations, and collaborates with Clinical, Regulatory, Analytical and QA teams.

Qualifications

• PhD or Master's with 8+ years (Pharma/biotech) experience; relevant field required.
• Strong knowledge of physical pharmacy, biopharmaceutics and drug delivery.
• Experience in formulation development of small molecules and oral dosage forms.
• cGMP knowledge and regulatory submission familiarity.

Responsibilities

• Lead formulation development and manufacturing for Phase I–III studies.
• Coordinate tech transfers to CMOs and oversee scale-up activities.
• Collaborate cross-functionally with Clinical, Regulatory and QA teams.
• Provide guidance on development plans and project timelines.
• Mentor direct reports and liaise with external service providers.

Skills

Physical pharmacy

Biopharmaceutics

Drug delivery technologies

Oral dosage form

QbD tooling

DoE

Scale-up expertise

Problem solving

Leadership (if managing reports)

Education

PhD in a relevant scientific discipline

Tools

Electronic Lab Notebook

Job description

PTC Therapeutics, Inc. seeks a Senior Research Fellow, Formulation Development to lead formulation development and clinical supply manufacturing for Phase I–III programs, covering preclinical formulation design, preformulation characterization, process development and tech transfers.

The role manages internal and external resources, drives timely development and manufacture of phase-appropriate formulations, and collaborates with Clinical, Regulatory, Analytical and QA teams.