Position Overview
Beacon Hill Life Sciences is seeking an principal research scientist to provide technical leadership for the development of parenteral pharmaceutical products. This position will support product development activities spanning formulation, analytical evaluation, manufacturing process development, scale-up, and external manufacturing.The successful candidate will have a strong background in injectable product development and experience advancing complex pharmaceutical programs from development into clinical and commercial manufacturing environments.This is a full-time, on-site opportunity in the Indianapolis-area.
Responsibilities
- Lead scientific activities associated with the development of sterile pharmaceutical products.
- Plan and execute formulation studies designed to improve product performance, stability, and manufacturability.
- Apply analytical data to understand product quality, stability, degradation, and formulation behavior.
- Establish and optimize manufacturing processes for injectable products.
- Support translation of laboratory processes into larger-scale manufacturing operations.
- Coordinate technical transfer activities with external manufacturing and development partners.
- Investigate technical challenges related to formulation, processing, manufacturing, and product performance.
- Evaluate interactions between pharmaceutical formulations, packaging components, and delivery technologies.
- Develop experimental plans, interpret results, and communicate conclusions to multidisciplinary project teams.
- Prepare development reports, protocols, manufacturing documentation, and technical information supporting regulatory filings.
- Work closely with Quality, Regulatory, Engineering, Manufacturing, and other scientific functions throughout product development.
- Provide technical direction to project teams and mentorship to developing scientists.
- Participate in intellectual property and other technical documentation activities as appropriate.
Qualifications
- Advanced degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a comparable scientific discipline.
- Significant pharmaceutical or biotechnology industry experience, preferably supporting products through advanced development stages.
- Extensive experience developing sterile injectable or parenteral dosage forms.
- Strong knowledge of pharmaceutical formulation and process development.
- Experience with analytical approaches used to evaluate pharmaceutical product quality and stability.
- Demonstrated involvement in manufacturing scale-up and technology transfer.
- Experience working with external development or manufacturing organizations.
- Understanding of product-development requirements associated with pharmaceutical delivery systems and associated components.
- Experience preparing technical documentation supporting pharmaceutical development and regulatory programs.
- Ability to independently lead complex scientific initiatives while collaborating effectively across multiple technical disciplines.
- Strong technical writing, presentation, and communication skills.
Additional Experience of Interest
- Development of protein, peptide, biologic, or other complex pharmaceutical products
- Pharmaceutical product and delivery-system compatibility
- Sterile manufacturingCMC development
- Stability programs
- Process characterization and validation
- External manufacturing/technology transfer
- Clinical-to-commercial product development
Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.
California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Company Profile
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting .
Benefits Information
Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.
We look forward to working with you! Beacon Hill. Employing the Future
#J-18808-LjbffrPrincipal Research Scientist in indianapolis at Unknown Company
This position is listed as full time and onsite.