In this role you will:

• Develop, evaluate, and optimize complex injectable formulations and processes to meet target product profiles.
• Design and execute injectable formulation development trials in the laboratory and aseptic facilities and evaluate stability data to finalize formulation composition and manufacturing process.
• Work closely with Manufacturing Operations to manufacture small and large-scale feasibility batches of pharmaceutical products in an aseptic facility.
• Work closely with the Technical Operations Group to support the transfer of processes from the development stage to clinical trial and commercial manufacturing in an aseptic facility.
• Work closely with the development team to ensure timely completion of fee-for-service milestones for aseptic formulation and process development, and tech transfer of IND, NDA, ANDA, 503B, and 505(b)(2) injectable products into an aseptic facility.
• Proactively communicate project progress with peers, supervisor, client, and Project Management
• Maintain full cGMP compliance and adherence to quality practices across the organization.
• Demonstrates the ability to systematically approach aseptic formulation and process development technical challenges, preferably with analytical and/or aseptic manufacturing support experience.
• Write/review formulations, and manufacturing procedures, review stability protocols/reports, process validation protocols/reports, technology transfer documentation, and product development reports.

To be successful in this role, your background and experience should include:

• Experience writing, reviewing, and maintaining cGMP and cGLP documents, like Lab Notebooks and Batch Records.
• Experience in all areas of Pharmaceutical, e.g., CMO, CDMO, Clinical and commercial products is preferred.
• Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project, Proofreading skills, etc.
• Knowledge of Quality Management Systems such as Master Control and Trackwise.
• Knowledge of current federal, local, and international regulations regarding the Testing, production, and release of drug substances and products.
• Must have a good working knowledge of aseptic GMP techniques and manufacturing procedures and requirements.
• Ability to analyze data/information and resolve complex problems/issues, as required.
• Demonstrates the ability to focus on priorities to deliver against a deadline and manage shifting priorities.
• Demonstrates meticulous attention to detail in writing emails, reports, and document reviews.
• Demonstrates meticulous attention to cGMP and regulatory compliance across all facilities.
• Ability to teach/train others on technical concepts and cGMPs, SOPs, and Policies.
• Strong computer skills with proficiency in MS Word and Excel.

Ph.D. in Pharmaceutical Sciences, or Physical Sciences with 0-3 years of experience, OR
MS in Pharmaceutical Sciences, or Physical Sciences with 2-4 years of experience, OR
BS in Scientific Discipline, preferably with 4-6 years of experience

The Formulation Scientist must work on-site.

What can Pii offer you? (Besides an amazing and innovative culture?)

• All Inclusive - Full Benefits Package.
• PTO Package
• Company Social Events
• Team Member Assistance Program
• Professional Support & Development
• MUCH MORE!!

If you want the reward of major professional development and growth in a smaller organization while learning valuable new skills in a cutting-edge pharmaceutical development and manufacturing organization Pii may be the place for you.