POSITION OBJECTIVE: Responsible for planning, directing and coordinating the work activities and resources necessary for manufacturing products in accordance with established cost, quality, and performance objectives. Ensures compliance with cGMPs and ISO standards while consistently meeting on time delivery expectations. Oversees all manufacturing operations in a 24/5 production environment while developing a culture of diversity and engagement.
Essential Job Functions/Responsibilities
- Provide leadership in setting strategic objectives for the manufacturing departments
- Maintain awareness of business strategies and implements alternative strategies to gain competitive edge
- Monitor performance against plan and take corrective actions as required
- Recommend and manage implementation of process improvements while maintaining or increasing customer satisfaction and reducing risk
- Ensures expense control within the department, working within department budget
- Prepare documentation in support of new equipment purchase, installation and qualification (URS, NEPQ)
- Manage customer relations by participating in audits relating to manufacturing areas
- Lead and develop an effective team through communication, performance management, development plans and reward/recognition practices
- Ensure subordinates work to develop a culture of engagement and employee involvement
- Ensure compliance with established internal guidelines and external regulations
- Maintain current knowledge of dynamic regulatory environment
- Review processes for effectiveness, ensuring quality, safety, and delivery
- Manages the daily operations of all production areas, including formulation, filling, inspections, packaging, etc.
- Coordinates the manufacturing and engineering teams resources to support production demands
- Act as project manager of department and capital projects
- Develop, review and revise work instructions and procedures when necessary
- Focuses on measures to improve safety, efficiencies, yields, and profitability
- Active participation in team-based culture and LEAN initiatives, including 5S and safety programs
- Oversee timely and accurate resolution of customer inquiries or complaints relating to manufacturing related issues
- Other responsibilities as may be assigned
Required Education & Qualifications
- Bachelor's Degree in Engineering, Manufacturing or Science related field
- 5 years experience in a cGMP guided manufacturing environment, with 2+ years management/supervisory experience with direct supervision of department personnel
- Aseptic Processing experience, with a strong working knowledge of clean room technique and requirements is a plus
- Proven analytical ability to problem solve, perform root cause analysis and implement Corrective and Preventative Actions
- Experience with manufacturing cost analysis and capital expenditures
- Strong leadership experience in a fast paced manufacturing environment with demonstrated ability to execute strategic expectations
- History of developing and implementing Environmental Health & Safety programs and tracking matrices.
- Ability to work with individuals/teams at all levels within the organization
- Experience hiring and developing a self-directed work team
- Understanding of ERP systems and MS Office
- Superior writing skills to prepare documentation in support of new equipment purchase, installation and qualification
- Knowledge and experience in Lean Manufacturing techniques and Kaizen Events
- Strong project communication, management and organizational skills
- Product development experience is a plus
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.