Senior Manager - Parenteral Filling Operations

Initial Therapeutics, Inc.; Durham (NC); On-site; USD 96,000 - 140,800; Full time

Benefits offered by this job

401(k) Plan

Medical Benefits

Dental Benefits

Vision Benefits

Vacation Benefits

Life Insurance

Employee Assistance Program

Fitness Benefits

Job summary

An established industry player is seeking a Senior Manager for Parenteral Filling Operations to lead a dynamic team in a fast-paced manufacturing environment. This role is pivotal in ensuring operational excellence, safety, and quality in the production of life-changing medicines. The ideal candidate will have a strong background in manufacturing leadership, particularly in parenteral environments, and will be responsible for guiding a diverse team while driving continuous improvement initiatives. Join a forward-thinking company dedicated to making a positive impact on global health and well-being.

Qualifications

• Bachelor's degree in a science, engineering, or pharmaceutical field required.
• 3+ years in manufacturing leadership with direct reports.
• Experience with regulatory audits and leading cross-functional teams.

Responsibilities

• Lead staffing, training, and operations for filling operations.
• Ensure operational consistency and engage actively on the shop floor.
• Develop objectives to meet production and safety goals.

Skills

Leadership

Root Cause Analysis

Lean Manufacturing Principles

Technical Writing

Interpersonal Communication

Education

Bachelor's Degree in Science

Bachelor's Degree in Engineering

Bachelor's Degree in Pharmaceutical Field

Tools

Manufacturing Execution Systems

Job description

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Senior Manager - Parenteral Filling Operations

View more categories View less categories Discipline Manufacturing & Production ,Operations Required Education Bachelors Degree Position Type Full time Hotbed Best Places to Work

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Senior Manager for Filling Operations in the Parenteral Building is responsible for the staffing, training, and leadership of the filling operations. They are expected to lead by example and provide coaching to cross functionally in the areas of safety, quality, operational execution, sterility assurance, and continuous improvement. The Senior Manager is also responsible for leading their respective process team per Lilly’s Manufacturing Standards for Operational Excellence. The Senior Manager and will be responsible for the leadership of 4 to 8 supervisors managing four 12-hour shift rotations. The team will be responsible for commercial operations as well as supporting qualification activities on management of material preparation and material movement. The position will report into the Operations Director responsible for Classified Space Activities.

• Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area.
• Senior Manager is responsible for a work force of approximately 40 – 70 individuals on various shifts, with multiple shift supervisors reporting directly to them.
• Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations.
• Provide leadership and develop objectives to deliver Business Plan Goals as it relates to production volumes, financial, safety, quality, stewardship, and people.
• Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Participates in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
• Lead/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
• The Manager functions as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety issues.
• Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for audit tours and discussions.
• Senior Manager is responsible for leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support.
• Understand and influence the manufacturing control strategy for their area.
• Represent their Operations Process Team on the Plant Flow Team.

Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical related field of study.
• Prior experience working with isolator technology
• At least 3 years working in a manufacturing environment managing frontline leadership with direct reports.
• At least 1 year working in the parenteral manufacturing environment with Grade A classified spaces or higher.
• Prior experience with regulatory audits and managing area tours with auditors.
• Previous management or leadership experience including leading or working effectively with a cross functional group.
• Experience with root cause analysis, technical writing / authoring investigations, knowledge of lean manufacturing principles

Preferred skills and/or experience:

• Previous experience in facility/area start-up environments
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• Solid understanding of basic requirements of regulatory agencies such as the FDA or EMEA.
• Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)
• Excellent interpersonal, written, and oral communication skills.
• Strong technical aptitude and ability to mentor others.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$96,000 - $140,800

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Senior Manager for Filling Operations in the Parenteral Building is responsible for the staffing, training, and leadership of the filling operations. They are expected to lead by example and provide coaching to cross functionally in the areas of safety, quality, operational execution, sterility assurance, and continuous improvement. The Senior Manager is also responsible for leading their respective process team per Lilly’s Manufacturing Standards for Operational Excellence. The Senior Manager and will be responsible for the leadership of 4 to 8 supervisors managing four 12-hour shift rotations. The team will be responsible for commercial operations as well as supporting qualification activities on management of material preparation and material movement. The position will report into the Operations Director responsible for Classified Space Activities.

Key Deliverables:

• Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area.
• Senior Manager is responsible for a work force of approximately 40 – 70 individuals on various shifts, with multiple shift supervisors reporting directly to them.
• Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations.
• Provide leadership and develop objectives to deliver Business Plan Goals as it relates to production volumes, financial, safety, quality, stewardship, and people.
• Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Participates in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
• Lead/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
• The Manager functions as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety issues.
• Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for audit tours and discussions.
• Senior Manager is responsible for leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support.
• Understand and influence the manufacturing control strategy for their area.
• Represent their Operations Process Team on the Plant Flow Team.

Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical related field of study.
• Prior experience working with isolator technology
• At least 3 years working in a manufacturing environment managing frontline leadership with direct reports.
• At least 1 year working in the parenteral manufacturing environment with Grade A classified spaces or higher.
• Prior experience with regulatory audits and managing area tours with auditors.
• Previous management or leadership experience including leading or working effectively with a cross functional group.
• Experience with root cause analysis, technical writing / authoring investigations, knowledge of lean manufacturing principles

Preferred skills and/or experience:

• Previous experience in facility/area start-up environments
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• Solid understanding of basic requirements of regulatory agencies such as the FDA or EMEA.
• Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)
• Excellent interpersonal, written, and oral communication skills.
• Strong technical aptitude and ability to mentor others.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$96,000 - $140,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live.Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit.

Company info

Location 893 S Delaware St
Indianapolis
Indiana
46285
United States

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