Pacira BioSciences, Inc. · 1 week ago

Principal Scientist, Analytical Development

Boston, MA

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

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Responsibilities

Manage the external development, qualification, and validation of analytical release and characterization methods for the helper dependent adenoviral gene therapy program.

Manage multiple stability and/or comparability programs and critically evaluate the experimental results.

Work closely with other departments for manufacturing efforts including internal and external collaborative organizations.

Contribute to documents for regulatory submissions and/or review.

Represent CMC at project team meetings as needed.

Provide cross-training and guidance from within CMC to ensure a high functioning program.

Maintain high level of technical knowledge in areas of responsibility.

Apply the knowledge, skills and experience obtained to increase efficiency in solving new problems.

Qualification

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Gene therapy expertiseAnalytical development managementAdenoviral CGT knowledgeGMP knowledgeRegulatory requirements knowledgeMolecular biology techniquesCellular biology techniquesExperimental plan developmentMicrosoft Office proficiencyStrategic decision makingCollaborative leadershipDocumentation skills

Required

PhD in biology, chemistry, or a related field with at least 8 years of experience in development or a related role.

Alternatively, candidates with an MS in a relevant field can be considered if they have a minimum of 12 years of experience in a similar role.

Strong preference for experience within the CGT field.

Extensive knowledge of the analytical techniques and trends within adenoviral CGT, particularly molecular and cellular biology.

Thorough understanding of the principals upon which CMC analytical and process development methodology is based.

Extensive knowledge of GMP, regulatory requirements, guidelines and standard CGT practices.

Ability to develop experimental plans for characterization and optimization of existing processes.

Strong organizational skills (e.g. daily tasks, documentation, archived information).

Strong interpersonal skills (e.g. working with other teams and organizations to achieve shared goals).

Proficient in the use of computers and widely used workplace applications (e.g. Microsoft Office, Outlook, graphing software, etc.).

Hands-on approach with a strategic and operational focus; capable decision maker in the execution of responsibilities with a high degree of flexibility to adapt to company and industry changes.

Collaborative leader able to operate effectively and with a strong sense of urgency in a fast-paced environment.

Organized problem solving and troubleshooting skills (e.g. rational progression of investigation).

Comfortable challenging the status quo and bringing forward innovative solutions to make better possible.

Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.

Excellent documentation skills (e.g. notebook, reports).

Outstanding communicator: direct, effective, clear, concise, well organized and appropriate. (e.g. able to participate in scientific discussions and written interactions).