Associate Principal Scientist, Sterile Product Development

* Lead/ contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of experimental plans and data analysis
* Support both early and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.
* Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation.
* Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.
* Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals.
* Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.
* Leads project activities at external manufacturing sites including tech transfers
* Enhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations
* Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others
* Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant industry experience.
* B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.
** Required

Experience and Skills:

*
* * Experienced in biologics process development and characterization particularly for late stage programs
* Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process
* Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas
* Has broad knowledge of formulation science and in depth-knowledge in multiple areas, including core understanding of the drug development process
* Track record of working effectively with team-members of diverse skill sets and backgrounds
* Strong verbal and written communication skills
* The candidate should have a strong track record in product development/ regulatory filing/ drug delivery/ complex formulation and process development/ characterization reflected through industry experience and external publications/ patent.
* Deep understanding of one or more of the following: surface science, colloid science, particle engineering and/or high concentration formulations
* Prior experience leading development projects at an enterprise level
* Capable of mentoring individuals in a peer-to-peer fashion and as a technical mentor
* Recognized as a subject matter expert in at least one drug delivery and/or manufacturing technology
* Demonstrated ability to identify, fundamentally characterize and address manufacturing challenges through the development and optimization of novel production technologies.
* Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.
* Prior experience with process scale up, modeling, regulatory filings and/or driving key capability evaluation/ build would be highly preferred.
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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