BioSpace, Inc.
Night Shift Supervisor, Aseptic Filling
BioSpace, Inc., Concord, North Carolina, 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.
Position Overview
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.
If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity!
During the project phase, the Operations Supervisor will have responsibility of supporting start-up activities to bring the Parenteral (PAR) area into service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include coordinating start-up support amongst self and team to; train on the use of the equipment and develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities. This position will require travel domestically (2-4 week trips and/or 3-12 month short term assignments) 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 Supervisor role is responsible for leadership of the team that operates the multiple PAR. They will develop an inclusive culture and technical expertise of manufacturing team and employees. This individual will ensure that the lines are adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role includes line leaders and operators.
As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles.
Key Objectives / Deliverables:
IntegrityLeading by examples 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.Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.Excellence
Collaborate with area supervisors to ensure a high standard of; communication, best practice sharing, and consistency across the groups and different shifts.Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence.Striving and encouraging a mindset of continuous improvement. Gathering ideas for improvement, articulating their business value, and working with support team to implement the ideas with highest objective value.Ensures there are enough adequately trained and compliant personnel staffed to meet production goals. Reviews and updates training plans as needed to maintain compliance and excellence.Develop area documentation (procedures, work instructions, job aides, etc.) with team to support start-up, training, and operation.Originate & Investigate deviations, operational quality issues, and support determination of root cause. Support implementation of corrective actions to ensure consistent quality.Respect for People
Support the site in building a diverse, empowered, and capable team.Responsible for managing several direct reports working across multiple manufacturing lines on responsible shift.Responsible for the coaching, development, and performance evaluation of operators.Communicate cross functionally with support team if there are quality, equipment, operational concerns.Requirements (Education, Training, and Experience)
Education, Experience and Skills
High School Diploma or equivalentPrior supervisory experienceBasic computer skills (desktop software, MS Office) are required.Previous experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable).Excellent interpersonal, written, and oral communication skillsStrong organizational skills and ability to handle and prioritize multiple requests.Strong technical aptitude and ability to train and mentor others.A valid drivers licenseTime Commitments and Work Authorization
Ability to work overtime as requiredAbility to wear safety equipment (glasses, shoes, gloves, etc)Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.The position may require a short term assignment of 3-12 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory.Willingness to work a 12-hour night shift (6pm to 6am on 2-2-3 schedule)Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.Preferred Attributes:
Experience with, completion of, or understanding of:
4+ years in manufacturing/operations with 2+ years in supervisory rolecGMP standards and FDA (or other industry) guidelines for productionSTEM degree or certificationAseptic filling, single use assemblies, isolator technology.Automated, semi-automated, and/or manual inspection.Highly automated equipment (inspection, packaging, filling, assembly, etc.)Manufacturing Execution Systems and SAP or other electronic business systemsContinuous improvement methodologies and mindset - lean, six sigma, etc.Root cause analysis and implementing corrective actionsAbility to organize and motivate teamsFacility, Equipment, Systems, Start-up
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.
#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.
Position Overview
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company's capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.
If you ever wanted to have a direct impact building a team's culture and in how the team operates, now is the perfect opportunity!
During the project phase, the Operations Supervisor will have responsibility of supporting start-up activities to bring the Parenteral (PAR) area into service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include coordinating start-up support amongst self and team to; train on the use of the equipment and develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities. This position will require travel domestically (2-4 week trips and/or 3-12 month short term assignments) 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 Supervisor role is responsible for leadership of the team that operates the multiple PAR. They will develop an inclusive culture and technical expertise of manufacturing team and employees. This individual will ensure that the lines are adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role includes line leaders and operators.
As a site leader and expert at our growing site, you'll have significant opportunities for growth into future leadership and technical roles.
Key Objectives / Deliverables:
IntegrityLeading by examples 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.Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.Excellence
Collaborate with area supervisors to ensure a high standard of; communication, best practice sharing, and consistency across the groups and different shifts.Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence.Striving and encouraging a mindset of continuous improvement. Gathering ideas for improvement, articulating their business value, and working with support team to implement the ideas with highest objective value.Ensures there are enough adequately trained and compliant personnel staffed to meet production goals. Reviews and updates training plans as needed to maintain compliance and excellence.Develop area documentation (procedures, work instructions, job aides, etc.) with team to support start-up, training, and operation.Originate & Investigate deviations, operational quality issues, and support determination of root cause. Support implementation of corrective actions to ensure consistent quality.Respect for People
Support the site in building a diverse, empowered, and capable team.Responsible for managing several direct reports working across multiple manufacturing lines on responsible shift.Responsible for the coaching, development, and performance evaluation of operators.Communicate cross functionally with support team if there are quality, equipment, operational concerns.Requirements (Education, Training, and Experience)
Education, Experience and Skills
High School Diploma or equivalentPrior supervisory experienceBasic computer skills (desktop software, MS Office) are required.Previous experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable).Excellent interpersonal, written, and oral communication skillsStrong organizational skills and ability to handle and prioritize multiple requests.Strong technical aptitude and ability to train and mentor others.A valid drivers licenseTime Commitments and Work Authorization
Ability to work overtime as requiredAbility to wear safety equipment (glasses, shoes, gloves, etc)Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.The position may require a short term assignment of 3-12 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer's factory.Willingness to work a 12-hour night shift (6pm to 6am on 2-2-3 schedule)Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.Preferred Attributes:
Experience with, completion of, or understanding of:
4+ years in manufacturing/operations with 2+ years in supervisory rolecGMP standards and FDA (or other industry) guidelines for productionSTEM degree or certificationAseptic filling, single use assemblies, isolator technology.Automated, semi-automated, and/or manual inspection.Highly automated equipment (inspection, packaging, filling, assembly, etc.)Manufacturing Execution Systems and SAP or other electronic business systemsContinuous improvement methodologies and mindset - lean, six sigma, etc.Root cause analysis and implementing corrective actionsAbility to organize and motivate teamsFacility, Equipment, Systems, Start-up
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.
#WeAreLilly