Formulation Scientist, Aseptic

Job Overview:

Formulation and process development scientist for aseptic drug products.

Responsibilities:

• 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.
• Write/review formulations, and manufacturing procedures, review stability protocols/reports, process validation protocols/reports, technology transfer documentation, and product development reports.
• Perform other duties as assigned.

Qualifications:

• Ph.D. in Pharmaceutical Sciences, or Physical Sciences with 0-3 years of experience, MS in Pharmaceutical Sciences, or Physical Sciences with 2-4 years of experience, BS in Scientific Discipline, preferably with 4-6 years of experience or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Experience in all areas of Pharmaceutical, e.g., CMO, CDMO, Clinical and commercial products is preferred.
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).