Sr. Scientist II, Formulation & Clinical Manufacturing

*Onsite in Alameda, Caliornia*

*Client offers sponsorship, and relocation to California*

SUMMARY: The Senior Scientist II works in a fast-paced environment with the Formulation development team, part of PSC department to drive a science-based approach in formulation development and strategy for small molecule projects from First in Human (FIH) formulations to commercial formulation development. The Sr. Scientist II will actively engage with key stakeholders from Process Chemistry, Quality, Clinical Supplies, and Analytical teams to support program timelines and goals.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Integrates physicochemical properties, solid-state properties and preclinical formulation to drive formulation development for FIH studies, CTM manufacturing, to late-phase clinical formulations including commercial formulation development.
• Works closely with colleagues in process chemistry and analytical for developing appropriate formulations.
• Works closely with colleagues in clinical supply chain, quality, logistics and CMO’s to plan, execute and deliver CTM batches.
• Provides clear and concise communications and instructions to partner CMOs for development and manufacturing of CTM supplies.
• Manage CMOs effectively to the highest performance standards, monitored through meaningful KPI’s and exhaustive analytics
• Collaborates with formulation team to develop and manufacture oral formulations (tablets, capsules, solns./susp.) internally for transfer to CMOs.
• Expands formulation science capabilities via innovation and/or new emerging technologies. Keeps current with the latest literature approaches in Formulation Sciences.
• Prepares and organizes data for presentation using analysis and visualization software, present data and reports on project status at individual, group, and departmental research meetings.
• Maintain laboratory notebook in a complete, consistent, and concise manner in accordance with company intellectual property policies and practices.
• Adheres to good health and safety practices and compliance with applicable EH&S rules and participate in mandatory safety training programs.
• Travels to CMOs and monitors CTM manufacturing as expected.

SUPERVISORY RESPONSIBILITIES:

• Not currently expected.

EDUCATION/EXPERIENCE/SKILLS:

Education:

• Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering or other relevant field and a minimum of 2 years of relevant experience in the pharmaceutical industry; or,
• Equivalent combination of education and experience.

Experience:

• Extensive experience with formulation development of solid oral formulations (tablets, capsules, others) from FIH to CTM supplies manufacturing and commercial supplies.
• Hands-on experience with developing suitable formulation for various routes of administration primarily solid oral formulations.
• Experience in QbD-based formulation development including statistical design, utilization of scale-independent process parameters, and evaluation of experimental results in designing bioavailable, robust, scale-able formulations.
• Experience working in-house and managing work at CMOs/CDMOs is preferred.

Knowledge/Skills/Abilities:

• Knowledge around physiochemical properties of small molecules and experience integrating properties in formulation development.
• Proficiency with software packages such as JMP (or equivalent).
• Extensive In-depth understanding of how the individual experiments fit within a larger research program to meet organizational goals.
• Strong understanding and application of scientific principles, theories, and concepts in field of specialty and other related disciplines.
• Excellent collaborative, verbal and written communication skills, problem solving, self-motivation, critical thinking, and organization skills.
• Detail oriented, can multi-task and work on multiple projects concurrently. Ability to work in a fast-paced organization.
• Demonstration of independent thought/creativity in science and drug research. Experience in applying current approaches and technologies to strengthen and improve formulation development capabilities.
• Excellent collaborative verbal and written communication skills.

WORKING CONDITIONS:

• Environment: Primarily working indoors in a laboratory and office environment.
• This is a lab-based role, and the candidate is expected to be on-site based on company policies.
• Travel required – 20% of the time.