Lead Scientist – Sterile Formulations Development

Objective 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.

The successful candidate will play a pivotal role in developing and optimizing injectable radiopharmaceutical formulations and associated manufacturing processes in a cGMP-compliant environment .

Working in a fast-paced, integrated, and multidisciplinary environment, the successful candidate is expected to collaborate cross-functionally while also delivering strong independent contributions that support product advancement to late-stage clinical development and commercialization.

Objective 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.

Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skill, and / or ability required.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education / Experience 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.

Experience in radiopharmaceuticals or isotope-based therapeutics is strongly preferred.

Knowledge / Skill / Ability 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.

Prior radiochemistry experience and knowledge of radioactive material handling are a plus.

Strong organizational skills, with the ability to manage multiple priorities and meet tight deadlines.

Work independently and proactively in a highly matrixed environment.

Work Environment                                                                                                                               The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

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%.   Powered by JazzHR