Associate Director - Device, Assembly, and Packaging

Initial Therapeutics, Inc.; Pleasant Prairie (WI); On-site; USD 123,000 - 198,000; Full time

Job summary

Initial Therapeutics, Inc. is seeking an Associate Director (AD), Operations in Pleasant Prairie, Wisconsin. This role involves staffing, training, and leadership within the operations group for parenteral and packaging processes.

The ideal candidate will have at least 7 years in the pharmaceutical industry, including previous management experience, and will ensure operational consistency and performance improvements while leading a team of approximately 40-70 individuals.

Qualifications

• At least 7 years working in the pharmaceutical industry.
• Previous management or leadership experience.
• Solid understanding of FDA and other regulatory requirements.

Responsibilities

• Responsible for staffing, training, and leadership of operations.
• Lead area deviation and corrective action discussions.
• Ensure consistency of operations across shifts.

Skills

Leadership

Communication

Technical aptitude

Continuous improvement mindset

Education

Bachelor's degree in a STEM or pharmaceutical related field

Tools

Trackwise

Veeva

Job description

Responsibilities

During the project phase, the Associate Director (AD), Operations is responsible for 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. Once the facility is turned over to operations, the AD role is responsible for ensuring the group meets annual production goals as well as planning through 1–3-year horizons. The AD will be responsible for leading their respective cross‑functional process teams. Direct line supervision for this role includes supervisors and operations associates.

Key Objectives & Deliverables

• Comfortable with exercising and encouraging Stop Work Authority for all employees if there is a perceived unsafe or product impacting situation.
• Lead and conduct area deviation and corrective action discussions with a cross‑functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety and Environmental (HSE) functional groups.
• Present operations investigations and procedures to regulatory agencies and act as a subject‑matter expert (SME) for related inspections, tours, and discussions.
• Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and practice vs. procedure evaluations.
• Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve.
• Participate in the development and implementation of strategies focused on continuous improvement, root cause analysis (RCA), failure modes effect analysis (FMEA), and operational standards for supply chain excellence (OSSCE).
• Understand and influence the manufacturing control strategy for their area.
• Support site leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the parenteral/DAP manufacturing area.
• Responsible for a workforce of approximately 40–70 individuals on various shifts, with multiple shift supervisors and associates reporting directly to them.
• Provide leadership and develop objectives to deliver business plan goals as it relates to production volumes, finances, safety, quality, stewardship and people.
• Act as a primary contact for other areas such as production planning, HR, quality assurance, engineering and environmental/safety.
• Lead the Operations Process Team, a cross‑functional group charged with making medicine, continuous improvement and site support.
• Represent their 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.

Preferred Qualifications

• 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).

Additional Information

• Ability to wear safety equipment (glasses, shoes, gloves, etc.).
• Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives.

Compensation

Salary range: $123,000 - $198,000 per year.

EEO Statement

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.