BioSpace, Inc.
Associate Director, Parenteral Operations - Visual Inspection Job at BioSpace, I
BioSpace, Inc., Concord, NC, United States, 28027
Job Details
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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $173,800
Position Description
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 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 are looking for people who are determined to make life better for people around the world and embody our company values of Integrity , Excellence , and Respect for People
Position Overview
Lilly is investing over $1 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina which will house warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need.
If you ever wanted to have a direct impact on building a team's culture and on how the team operates, now is the perfect opportunity!
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) areas which include formulation, aseptic isolator barrier filling, and visual inspection areas. This position will require travel domestically with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently
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. They are expected to lead by example and provide coaching to others in the areas of safety, quality, operational excellence, compliance, and continuous improvement. The AD will be responsible for leading their respective cross-functional process teams. Direct line supervision for this role includes Supervisors and Operations Associates.
As a site leader and expert at our growing site, you will have significant opportunities for growth into future leadership and technical roles.
Key Objectives / Deliverables
Integrity
Education, Experience, and Capabilities
Experience with, completion of, or understanding of:
This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
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
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.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $173,800
Position Description
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 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 are looking for people who are determined to make life better for people around the world and embody our company values of Integrity , Excellence , and Respect for People
Position Overview
Lilly is investing over $1 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina which will house warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need.
If you ever wanted to have a direct impact on building a team's culture and on how the team operates, now is the perfect opportunity!
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) areas which include formulation, aseptic isolator barrier filling, and visual inspection areas. This position will require travel domestically with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently
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. They are expected to lead by example and provide coaching to others in the areas of safety, quality, operational excellence, compliance, and continuous improvement. The AD will be responsible for leading their respective cross-functional process teams. Direct line supervision for this role includes Supervisors and Operations Associates.
As a site leader and expert at our growing site, you will have significant opportunities for growth into future leadership and technical roles.
Key Objectives / Deliverables
Integrity
- Leading by example with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
- 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
- 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 the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), 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 manufacturing area.
- Responsible for a work force 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.
- Leading 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.
Education, Experience, and Capabilities
- 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
- 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.
- Position will involve frequent business trips domestically with potential international travel to support testing of equipment at vendor sites, visit Lilly sites to learn and collaborate, and to build global network.
- Travel domestically and internationally, up to approximately 20% of the year to learn and network with colleagues.
Experience with, completion of, or understanding of:
- 6+ years in manufacturing/operations with 4+ years in supervisory role
- cGMP standards and FDA (or other industry) guidelines for production
- Aseptic filling, single use assemblies, isolator technology.
- Automated, semi-automated, and/or manual inspection.
- 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)
This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
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