Manager, Scientist - Analytical Development

Pacira Pharmaceuticals, Inc.

3d•$103,000 - $140,000

About The Position

At Pacira, innovation meets purpose. Pacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. Today, we’re building on that legacy with next-generation innovations for chronic, postsurgical, and musculoskeletal pain. Our culture is built on collaboration, innovation, and a shared commitment to helping patients recover faster. We are redefining what’s possible in pain management—and we can’t do it without talented people like you. Why Join Us? At Pacira, every career is more than a job. Our mission drives us, and every day, we challenge ourselves to achieve the extraordinary. Integrity is at the core of who we are. We value diverse perspectives and the collective strength of a unified team. Join the team in making better possible for patients everywhere. Summary: The purpose of this position is to provide gene therapy expertise, execution, and organization of analytical development efforts, particularly within the molecular biology space.

Requirements

The position requires a PhD in biology, chemistry, or a related field with at least 2 years of experience in development or a related
Alternatively, candidates with an BS or MS in a relevant field can be considered if they have a minimum of 3 years of experience in a similar role.
Extensive knowledge of the analytical techniques and trends within adenoviral CGT, particularly management of external CxO partners and protocol driven studies.
Thorough understanding of the principles upon which Quality driven analytical and process development methodology is based.
Extensive knowledge of GMP, regulatory requirements, guidelines, and standard CGT practices
Solid understanding of statistical modeling systems and relevant software options.
Ability to develop experimental plans for characterization and optimization of existing
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
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
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 (e.g., able to participate in scientific discussions and written interactions)

Nice To Haves

Strong preference for experience within the CGT field

Responsibilities

Manage, organize, and drive multiple stability and comparability programs and critically evaluate the experimental results with external technical partners.
Experience with CTO partners to manage and evaluate a growing data set from qualified assays tracking OOS/OOT as well as specification setting for future validation work.
Manage the external development, qualification, and validation of analytical release and characterization methods for the helper dependent adenoviral gene therapy platform.
Statistical tracking and evaluation of multiple protocols using software statistical programs like JMP.
Work closely with other departments for manufacturing efforts including internal and external collaborative
Contribute to documents for regulatory submissions and/or
Represent CMC at project team meetings as
Provide cross-training and guidance from within CMC to ensure a high functioning
Maintain high level of technical knowledge in areas of
Apply the knowledge, skills and experience obtained to increase efficiency in solving new