Pacira BioSciences, Inc. ยท 17 hours ago
Manager, Scientist - Analytical Development
United States
Full-time
Remote
Entry, Mid Level
$103K/yr - $140K/yr
2+ years expPacira BioSciences, Inc. is a pioneer in non-opioid pain management and regenerative health solutions. The purpose of this position is to provide gene therapy expertise, execution, and organization of analytical development efforts, particularly within the molecular biology space.
Pharmaceuticals
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
Qualification
Required
PhD in biology, chemistry, or a related field with at least 2 years of experience in development or a related field
Alternatively, candidates with a BS or MS in a relevant field can be considered if they have a minimum of 3 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 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 methods
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
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 able to participate in scientific discussions and written interactions
Benefits
Medical, Prescription, Dental, Vision Coverage
Flexible Spending Account & Health Savings Account with Company match
Employee Assistance Program
Mental Health Resources
Disability Coverage
Life insurance
Critical Illness and Accident Insurance
Legal and Identity Theft Protection
Pet Insurance
Fertility and Maternity Assistance
401(k) with company match
Flexible Time Off (FTO) and 11 paid holidays
Paid Parental Leave
Company
Pacira BioSciences, Inc.
Guided by our belief that better is possible, we innovate and deliver therapies that reimagine life beyond pain, empowering patients and clinicians with advanced options that challenge the status quo of care.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Frank Lee
Chief Executive Officer
Charles A Reinhart, III
Chief Financial Officer
Company data provided by crunchbase