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Tundra Technical Solutions · 4 weeks ago

Scientist, Pre-Formulation & Drug Product Development

Ridgefield, CT

Contract

Onsite

Senior Level

$56/hr - $61/hr

5+ years exp

Tundra Technical Solutions is involved in drug product development activities across early and clinical-stage programs. The Scientist role focuses on formulation development, clinical manufacturing support, and technology transfer while ensuring compliance with regulatory requirements.

EmploymentRecruitingStaffing Agency

Hiring Manager

Earl Cammon

Responsibilities

Support delivery of drug product development activities, including:

Pre-formulation and formulation development

Process development and tech transfer

Phase-appropriate stability studies

GMP clinical trial material (CTM) manufacturing

Contribute to drug substance/drug product supply activities, including preparation and review of GxP documentation and technical summaries

Support regulatory document authoring and review (e.g., IND, IMPD, NDA sections) and assist in responses to health authority questions

Collaborate with external CROs, CMOs, and CDMOs on formulation development, manufacturing execution, and technology transfer

Review and approve technical reports, manufacturing documentation, and development data for accuracy and compliance

Work cross-functionally with CMC, Quality, Regulatory, and Development teams to support program execution

Ensure compliance with applicable GMP, GLP (as applicable), safety, quality, and corporate policies

Present scientific data internally and contribute to technical discussions and decision-making

Qualification

Preclinical formulationDrug product formulationTech transferCGMP manufacturing supportICH quality guidelinesFDA/EU regulationsGxP documentation reviewTechnical presentationsCross-functional collaboration

Required

Hands-on experience in preclinical formulation and pre-formulation characterization

Drug product formulation and process development (QbD)

Tech transfer and cGMP manufacturing support

Experience developing phase-appropriate drug product and supporting clinical supply manufacturing for small molecules and/or oligonucleotides

Experience working with and coordinating activities across external CROs and CDMOs/CMOs

Familiarity with ICH quality guidelines and FDA/EU drug manufacturing regulations

Ability to review and approve GxP documentation and technical reports

Strong written and verbal communication skills, including technical presentations to scientific and cross-functional audiences

Ability to work effectively in cross-functional and matrixed team environments

Master's degree in Chemistry, Chemical Engineering, or Pharmaceutical Sciences with 7 + years of relevant industry experience OR PhD in a related discipline with 5+ years of relevant industry experience in drug product development