Job Description

Job Description

The Associate Director, Head of IG Filling and Packaging Manufacturing, will lead two multi-shift departments, each with 40+ team members, for the aseptic filling, manual visual inspection, and final packaging operations. The successful candidate will be responsible for all aspects and KPIs of the area, including the safety of employees, the compliance of the area to meet FDA regulations, the quality of the product, the culture of the team, and the supply of product to our patients as the highly automated greenfield site continues to ramp up to full capacity. The successful candidate will also lead a cross functional manufacturing unit (MU) team of leaders to decide on key projects and priorities for the departments. The successful candidate must have strong critical thinking skills to evaluate options when making decisions as well as strong interpersonal and communication skills to collaborate with the manufacturing team and MU leaders.  

Responsibilities

Ensures organization adheres to policies and procedures governing environmental, health, and safety, requirements.

Responsible for all IG Filling & Packaging operations at the facility which operates five days a week in different shifts.

Ensure products are provided to customers on time so that product quality, yield, operating costs, and process efficiencies are met.

Commit to employee feedback and developmental processes.

Responsible for defining near-term and mid-term strategic plans for the extended organization. Implements required actions and staffing plans to deliver committed results.

Champion a culture of continuous improvement that leverages lean manufacturing principles.

Develops annual operating budget and executes all operational activities to meet or beat financial plan.

Regularly interacts with leaders from Quality, Supply Chain, Technical Services, other Plants, and Division to resolve issues, drive improvement activities, and prioritize initiatives and resources.

Develops self, direct reports, and high potential employees. Manages an organization of 45 people, significant budget, and value of production (VOP).

Lead of the IG Filling and Packaging Manufacturing Unit

Member of the IG Leadership Team

Key Skills, Abilities, and Competencies

Ability to manage activities of departments through subordinate managers who exercise full supervision in terms of cost, methods, and employees.

Ability to interpret and analyze statistical data and financial reports, understand and resolve technical difficulties, interface with internal and external engineering/technical experts, and manage multiple priorities in a manufacturing environment setting.

Demonstrated leadership skills, including sponsoring/leading high performing cross-functional teams

Excellent communication and presentation skills, both oral and written, with a demonstrated ability to present key quality/department/business indicators to senior management.

Ability to drive change and motivate others toward a common vision.

Excellent facilitation, problem-solving, and analytical skills.

Must be confident, resourceful, creative, self-reliant, and self-motivated.

Understanding of global cGMP regulations and quality management systems for pharmaceutical or biotechnology operations, including participation in regulatory inspections.

Excellent interpersonal, influencing, and negotiating skills.

Strong project management, organizational, planning, and analytical skills.

Excellent working knowledge of world-class manufacturing techniques, including Lean and Six Sigma.

Interface with internal engineering/technical experts and external technical representatives.

Education and Experience Requirements

Minimum of a BS/BA degree in engineering or technical discipline. Master’s Degree or MBA is highly preferred.

8-10 years of experience in Biopharmaceutical/Pharmaceutical manufacturing leadership

Must have previous relevant experience leading manufacturing aseptic filling operations with a proven track record of success in leading complex organizations.

Experience in Lean Manufacturing and DMAIC, with a proven record of driving operational improvements.

Other Job Requirements

Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

No make-up, jewelry, contact lenses, nail polish, or artificial fingernails may be worn in the manufacturing environment.

May be required to enter/work in a cold, wet environment

Must be able to work as needed to cover multiple shifts, including weekends.

May be required to work in a confined area.

Some Clean-room and cool/hot storage conditions.

In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.