Manufacturing

• Completing drug product filling activities, respectively
• Performing initial review of manufacturing batch records
• Maintaining a safe and compliant culture by identifying preventative measures
• Creating and/or revising standard operating procedures
• Leading continuous improvement initiatives, which may be cross-functional in nature
• Performing data analysis (e.g., SPC, CPV) of critical process parameters and making recommendations to Engineering and/or Process Development teams
• Developing finite schedule for tasks including, but not limited to unit operations
• Monitoring productivity and identifying countermeasures for issues impacting cycle time adherence
• Elevating critical and impactful events to management
• Applying appropriate systems for job duties (SAP, QMTS, and LIMS etc.)
• Supporting the introduction of new products and technologies into the facility
• Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative Actions (CAPA)

High school diploma / GED and 2 years of Manufacturing experience OR Associate’s degree and 6 months of Manufacturing experience OR Bachelor’s degree

• B.S. in a life science or related field
• 2 years of work experience in a GMP environment
• Ability to perform computer operations, such as ability to navigate in MS Office and Excel
• Ability to operate specialized equipment and computers as appropriate to the individual area
• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to interact with inspectors (internal and external)
• Technical writing capabilities
• Ability to organize work, handle multiple priorities and meet deadlines
• Demonstrated written and oral communication skills
• Presentation capabilities
• Detail oriented as well as flexible and adaptable to changing priorities and requirements

• health and welfare plans for staff and eligible dependents
• financial plans with opportunities to save towards retirement or other goals
• work/life balance
• career development opportunities
• Retirement and Savings Plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• discretionary annual bonus program
• stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible