Assoc Prin. Scientist, Engineering

** Why You'll Love This Role:*
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* Key Responsibilities:

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* ** Technical leadership**:
Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.
** CMC RA**:
Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).
** Leadership:
** Establish, manage and support Cell Culture CMC teams, and align resources to deliver on priorities. Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff. Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.
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* Cross-Functional Collaboration:

** Unite diverse teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion, and equity. Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams.
** Communication:
** Foster collaboration, ensure transparency, and engage with governance bodies.

Excellent interpersonal and communication skills
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* Education & Experience:

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* * Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum three (3) years or relevant industry experience.

Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of relevant industry experience.
** OR
* * Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience.
** OR*
* * Proven leadership of functional teams in biologics development & commercialization
* Deep expertise in cell culture commercialization and manufacturing operations
* Strong understanding of regulatory requirements
* Ability to lead without authority, build trust, and inspire accountability
* Ethical, resilient, and committed to excellence
* Skilled in risk management, team facilitation, and strategic planning
* Experience in commercial manufacturing and CMC development
* Exceptional communication and stakeholder engagement skills
** 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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