Associate Director - Device, Assembly, and Packaging

Responsibilities

• Staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start up, and validation of the parenteral operations (PAR) OR device, assembly, and packaging (DAP) areas.
• Ensuring the group meets annual production goals and planning through 1–3-year horizons once the facility is turned over to operations.
• Leading cross-functional process teams and presenting operations investigations and procedures to Regulatory Agencies.
• Maintaining and communicating metrics to measure performance against business objectives and making necessary changes to continuously improve.
• Supporting Site Leadership in building a diverse and capable site organization while delivering area operational procedures, quality processes, and controls for the Parenteral/DAP manufacturing area.
• Providing leadership and developing objectives to deliver Business Plan goals relating to production volumes, finances, safety, quality, stewardship, and people.
• Acting as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering, and Environmental/Safety.
• Leading the Operations Process Team, a cross-functional group charged with making medicine, continuous improvement, and site support.
• Representing the Operations Process Team on the Plant Flow (value stream) Team.

Qualifications

• Bachelor's degree in a STEM or pharmaceutical related field of study.
• At least 7 years working in the pharmaceutical industry.
• Previous management or leadership experience including leading or working effectively with a cross functional group.
• Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA.
• Excellence in interpersonal, electronic, written, and oral communication.
• Strong technical aptitude and ability to train and mentor others.

Skills and Preferences

• 6+ years in manufacturing/operations with 4+ years in supervisory role.
• cGMP standards and FDA (or other industry) guidelines for production.
• Highly automated equipment (inspection, packaging, filling, assembly, etc.).
• Creation of standard operating procedures, work instructions, and training documentation.
• Equipment & Facility design documentation reviews.
• Facility, equipment, or system start up.
• Qualification and process validation experience.
• Manufacturing Execution Systems and electronic batch release.
• Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
• Continuous improvement methodologies and mindset – lean, six sigma, etc.
• Documentation, deviation and change management systems (e.g., Trackwise, Veeva, QualityDocs, Kneat).