Minaris - Director, Commercial Manufacturing Operations
$161,000–$180,000 year
On-siteAllendale, New Jersey, United States
Allendale, New Jersey, United StatesOn-siteFull Time$161,000–$180,000 yearSenior LevelBachelors Degree
Full TimeSenior LevelBachelors Degree
Job Summary
Lead day-to-day operations of the Commercial Manufacturing Operations department to ensure timely delivery of client-sponsored projects and drive quality, supply, and financial performance. Manage GMP and non-GMP facility environments, oversee production planning, and execute Manufacturing Service Agreements to meet client expectations and profitability targets. Develop operational policies, SOPs, and training curricula while maintaining full compliance with GxP, CFR, and site quality systems. Represent the organization during audits, coordinate preventive maintenance, and lead a high-performance team focused on continuous improvement and right-first-time execution. Collaborate with Quality Assurance, Project Management, and external stakeholders to align functional strategy with site and regional goals.
Required Qualifications
- Bachelor's degree or higher in relevant life science discipline
- 8-10+ years' direct experience working in a GMP regulated facility in the pharmaceutical or biotech commercial manufacturing environment
- Significant knowledge and understanding of CDMO operations
- Experience in strategic planning, process improvement, project execution, and data/business analytics
- Detailed knowledge of manufacturing technology, industry trends and requirements associated with the introduction of new equipment, systems, and processes into a manufacturing setting
- Comprehensive understanding and extensive practical experience with GMP quality systems and procedures
- Ability to adapt and evolve quickly in an ever changing and dynamic environment
- Self-awareness, integrity, authenticity, and a growth mindset
- Willingness to accept temporary responsibilities and assignments outside of this job description
- Must have the ability to work in a team-oriented environment and with clients
- Ability to be comfortable in a clean room environment
- Must utilize proper personal protective equipment (PPE)
- Must be able to handle the standard/moderate noise of the manufacturing facility
- Must be able to work during the weekend, holidays and as required by the company
- Must be able to travel to other sites
- Must be able to work in a team-oriented environment and with clients
- Must be able to work during the weekend, holidays and as required by the company
- Must be able to travel to other sites
Desired Qualifications
- 2+ years' experience working in cell processing, cell culture, cell analytics, and related GMP technologies, preferably for the manufacture of cell therapy products
- Hands on experience with autologous and/or allogeneic cell therapy manufacturing processes
- Ability to effectively interface with peer groups in the site and work collaboratively to achieve site goals
- An innovative, motivated, and independent leader with proven ability to work cross-functionally and drive accountability
- Proactive problem-solving skills
- Demonstrated ability to work creatively and effectively in a fast-paced CDMO environment
- Ability to lead through influence
- Strong business acumen to handle internal and external stakeholders
- Ability to think strategically and act tactically (detail-oriented)
- Strong interpersonal, communication, and analytical skills
- Excellent skills using Microsoft Office Suite
- Recognized skills for ability to develop efficient operations with robust processes and implementation of operational KPIs focused on Right First Time and On-time delivery
- Strong attention to detail while having the ability to work simultaneously on multiple priorities
- Demonstrated customer (internal and external) interaction skills
- Ability to effectively interface with peer groups in the site and work collaboratively to achieve site goals
- An innovative, motivated, and independent leader with proven ability to work cross-functionally and drive accountability
- Proactive problem-solving skills
- Demonstrated ability to work creatively and effectively in a fast-paced CDMO environment
- Ability to lead through influence
- Strong business acumen to handle internal and external stakeholders
- Ability to think strategically and act tactically (detail-oriented)
- Strong interpersonal, communication, and analytical skills
- Excellent skills using Microsoft Office Suite
- Recognized skills for ability to develop efficient operations with robust processes and implementation of operational KPIs focused on Right First Time and On-time delivery
- Strong attention to detail while having the ability to work simultaneously on multiple priorities
- Demonstrated customer (internal and external) interaction skills
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