United States flag

Sr Associate Scientist, Process Development

United States - California - Santa MonicaProcess/Product Development & OperationsRegular

Job Description

Scientific Project Manager- Analytical Development

We are seeking a highly motivated, detail-oriented individual for the role of Associate Scientist, Project Management to work in this exciting new area of cancer immunotherapy. The individual will work within cross functional groups in analytical development, process development and Quality Control to facilitate interdepartmental analytical method transfers and life cycle management. 

Duties:

  • Provide management support for analytical development projects including preparing and maintaining comprehensive project schedules, resources, and budget.
  • Facilitate method transfer from AD to QC facilities by authoring transfer documentation and training plans, and providing review of qualification/validation protocols and reports to meet filing standards
  • Lead gap and risk assessments to enable LCM of analytical methods to meet milestones for continuous improvement of commercial programs
  • Track deliverables and manage dashboard report outs on analytical development activities and follow up with teams as required to update statuses.
  • Manage documents, presentations and organize them on the shared site for the team to easily access. Work with IT to maintain team shared site and documents.
  • Collaborate with scientists and engineers to assist timely generation of process and technical reports to reach major milestones.
  • Organize, facilitate, and co-lead team meetings. Develop agendas, prepare minutes, track actions, maintain a risk register, and distribute key project information in a timely manner.
  • Implement project management tools. Proactively work to onboard best-in-class project management processes, tools/templates and support harmonization of these across projects and teams.
  • Support continuous improvement efforts across projects, identifying and addressing gaps and opportunities.
  • Other duties as assigned.

Basic Requirements:

  • Master’s Degree and 4+ years of related industry/academic experience OR
  • Bachelor’s Degree and 6+ years of related industry/academic experience OR
  • High School Degree and 8+ years of related industry experience

Preferred Requirements:

  • Proficiency in Smartsheet and Microsoft Office Suite (Outlook, Word, PowerPoint, etc.) is required.
  • Knowledge of biostatistics and method monitoring/trending analysis on JMP/Prism or other analysis software
  • Proficient in other project management tools such as Spotfire and Clarity is a strong plus.
  • Strong understanding of drug development and interdependencies.
  • Knowledgeable in cGMP manufacturing and CMC regulatory requirements for pharmaceuticals; cell therapy CMC experience is a strong plus.
  • PMP or other Project Management Certification desired
  • Able to think critically and demonstrate troubleshooting and problem-solving skills.
  • Excellent written, analytical, and oral communication skills
  • Strong interpersonal skills with ability to work effectively across matrix teams
  • Knowledge of how to create executive level charts, graphs and slides
  • Must be highly organized, proactive, efficient, and agile.
  • Must exhibit high emotional intelligence, with demonstrated ability to successfully negotiate through challenging situations, difficult conversations, and ambiguous assignments.
  • Skillful at building trust and team cohesion, with demonstrated track record of driving and leading teams, and influencing colleagues at all levels of the organization to achieve team, group, functional and corporate goals.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

#LI-ML1

#IND123