Principal Scientist, Analytical Ops

Job Description

We are seeking a highly motivated individual with a background in CMC analytical control strategy and method lifecycle management experience of Advanced therapy medicinal products to join us as a Principle Scientist, Analytical Operations, at our Santa Monica, California location. The individual will be an Analytical Sub-team Lead (ASTL) in Analytical Development who will work within cross functional groups with process development, quality, regulatory to lead the implementation of the analytical control strategy through the lifecycle of a program.

Responsibilities include (but are not limited to):

• Lead the overall implementation of the analytical control strategy

• Enable Analytical readiness for success of IND/BLA filings

• Serves as an analytical team Representative in Cross-functional forum

• Lead a core Analytical Sub-team within analytical to oversee the Analytical Control Strategy of program(s)

• Create analytical roadmaps and timelines with trackable key milestones that clearly reflect the CMC strategy

• Define and track project decisions, risks, action items, sampling plan, etc.

• Lead the efforts of method deployment to Quality Control. Strategic partner with Quality Control, representing Analytical function in Product Quality Team

• Strategic partner with Process Development representing Analytical in Product Development Team

• Provide regulatory filing support as needed as an Analytical Representative

• Collect feedback from Analytical sub-teams to continue improving business processes

• Besides being a strategic lead, the ASTL is accountable for many operational deliverables, like own program specific meetings, Analytical program risk register, oversee sampling plan from method development and phase-appropriate validation, etc.

Basic Qualifications:

• PhD and 5+ years of related industry

OR

• Master’s Degree and 8+ years of related industry experience

OR

• Bachelor’s Degree and 10+ years of related industry experience

Preferred Qualifications:

• In-depth experience of CMCs/cGMPs for Advanced therapy medicinal products (Cell Therapy and viral vectors for gene therapy)

• Understand ICH guidelines and other regulatory guidelines and requirements

• Basic knowledge in analytical techniques such as Flow cytometry, ddPCR, Potency and compendial methods techniques

• Project management experience and proficient in project management tools

• Excellent interpersonal, verbal, and written communication skills

• Ability to lead a cross-functional, diverse, experienced strategic and technical staff

• Ability to influence and lead without authority, influencing others and achieving desired outcomes through persuasion, collaboration, and building trust

• Ability to think critically and demonstrate troubleshooting and problem-solving skills, and work with and lead others

• Ability to function efficiently and independently in a changing environment

• Work independently. Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities

• Self-motivated, detail-oriented, excellent interpersonal skills, and willing to accept temporary responsibilities outside of initial job description