Lead Scientist – Sterile Formulations Development jobs in United States
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Perspective Therapeutics · 2 weeks ago

Lead Scientist – Sterile Formulations Development

positionSomerset, NJ
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
date5+ years exp

Perspective Therapeutics is seeking a highly motivated hands-on scientist with expertise in sterile injectable drug products to join our dynamic CMC drug product team. This role is critical in supporting the development of sterile injectable formulations and drug product process development from early development through scale-up and commercial manufacturing.

Health CareMedicalTherapeutics
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H1B Sponsor Likelynote
Hiring Manager
Randy Gilbert
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Responsibilities

Serve as the technical subject matter expert (SME) for formulation and drug product process development
Conduct formulation/process development studies, including comparability, stability, and compatibility assessments
Lead scale-up and technology transfer activities to support manufacturing
Draft detailed study plans to ensure that work is performed efficiently and in a scientifically sound manner
Monitor experiments (e.g. process development, formulation optimization) and ensure complex data are interpreted in a scientifically correct way
Support filter and container closure integrity validation studies and other special studies as necessary
Collaborate with cross-functional teams including Analytical, Quality, Regulatory, and Manufacturing
Author formulation and process development reports, study protocols, and regulatory CMC module 3 documentation to support late-stage IND and NDA submissions
Ensure all work is performed in accordance with company policies, procedures and safety standards
Ensure documents follow relevant regulatory standards (e.g., FDA, USP, ICH) and CMC guidelines
Troubleshoot and propose scientifically sound solutions in collaboration with internal teams
Provide technical support during regulatory inspections and audits, as needed

Qualification

Formulation developmentSterile drug product processQuality by design (QbD)Regulatory frameworksAseptic processingPharmaceutical product life cycleGMP quality systemsCommunicationOrganizational skillsIndependent work

Required

Ph.D. or M.S. or B.S. in Pharmaceutics, Chemistry, or related field
5-7 years of hands-on experience in formulation development and sterile drug product process development using quality by design (QbD) principles
Strong understanding of aseptic processing, formulation characterization, excipient compatibility, and container-closure systems
Experience with QbD principles and risk-based development approaches
Pharmaceutical product life cycle management
Deep expertise in regulatory frameworks (FDA, EMA), and clinical/commercial manufacturing
Familiarity with GMP quality systems and electronic document management systems
Ability to prepare detailed study protocols and interpret complex data sets across multiple techniques
Excellent communication skills, including the ability to explain technical concepts to cross-functional teams
Strong organizational skills, with the ability to manage multiple priorities and meet tight deadlines
Work independently and proactively in a highly matrixed environment
Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels
May be required to sit or stand for long periods of 8+ hours a day while performing duties
Willingness to complete safety training within allotted time limits, and work in a team-based environment
May require travel to Iowa up to 10%

Preferred

Experience in radiopharmaceuticals or isotope-based therapeutics is strongly preferred
Prior radiochemistry experience and knowledge of radioactive material handling are a plus

Company

Perspective Therapeutics

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Perspective Therapeutics focuses on advancing cancer treatments employing radiation, radiopharmaceuticals, and imaging technology.
dateFounded in 2022
location
Seattle, Washington, USA
people-size51-200 employees
web-link
https://perspectivetherapeutics.com/

H1B Sponsorship

Perspective Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)

Funding

Current Stage
Public Company
Total Funding
$257.6M
Key Investors
National Institutes of Health
2024-05-24Post Ipo Equity· $80M
2024-03-04Post Ipo Equity· $87.4M
2024-02-01Grant· $0.4M

Leadership Team

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Thijs Spoor
Chief Executive Officer
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Joel Sendek
Chief Financial Officer
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Recent News

FiercePharma
Biopharma CEOs assess the road ahead in 2026
2026-01-12
GlobeNewswire
Perspective Therapeutics Presents Updated Interim Data of [212Pb]VMT-α-NET in its Ongoing Phase 1/2a Clinical Trial at the 2026 ASCO Gastrointestinal Cancers Symposium
2026-01-11
Perspective Therapeutics, Inc.
Perspective Therapeutics Announces Acceptance of VMT-α-NET Data for Presentation at the ASCO Gastrointestinal Cancers Symposium
2025-12-04
Company data provided by crunchbase