About the Role
The Associate Manager, QA Shop Floor is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor personnel as well as working with manufacturing to troubleshoot issues.
Requirements
- Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
- Minimum of 1 year relevant work experience, preferably within a biological and/or pharmaceutical industry is required.
- Knowledge of Good Tissue Practices is required.
- Excellent written and oral communication skill are required.
- Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
- Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Comfortable with speaking and interacting with regulatory inspectors.
- Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
- Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
- Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
- Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
- Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
- Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
- Employs good project management principles to appropriately align time, resources, and budgets.
- Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
- Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.
- Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
- Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.
- Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change.
- Generates new solutions to problems by challenging the status quo and conventional thinking.
Nice to Have
- Experience in a Quality Control setting is preferred.
- Experience with processing samples in biosafety cabinets utilizing aseptic technique is strongly preferred.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is strongly preferred.
- Knowledge of CAR-T QC test methods and related equipment is preferred.
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- Paid time off policy includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
- Flexible spending and health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- Commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
Additional Information
- This position may require occasional travel to partner sites in NJ or PA as business demands.
- This position may require up to 5% domestic or international travel as business demands.
- Performance-based bonus and/or equity is available to employees in eligible roles.
- Benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech.
- Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
- Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
