BioSpace
Associate Director – TSMS Sterility Assurance
BioSpace, Pleasant Prairie, Wisconsin, United States, 53158
Associate Director – TSMS Sterility Assurance
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Associate Director – TSMS Sterility Assurance
role at
BioSpace
Company Overview 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 put people first and are looking for people who are determined to make life better for people around the world.
Responsibilities The Associate Director TS/MS – Sterility Assurance is responsible for the oversight of Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing. The role is responsible for leading and mentoring a technical staff and understanding parenteral aseptic processing as it relates to drug product manufacturing, specifically the formulation/filling/inspection of pharmaceutical products. The Associate Director will provide guidance on time management and priorities for direct reports and manage routine production support activities while balancing implementation of technical projects and program oversight.
This position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards related to sterility assurance. It also requires the ability to multitask/prioritize and excellent written and oral communication skills, decision‑making ability, interpersonal skills, and the ability to anticipate potential problems and develop/implement solutions. The role is expected to work with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plans, and quality objectives.
Key Objectives & Deliverables
Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
Technical and defendable contamination control strategy design and execution.
Performance management and development of staff.
Partner within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
Technical review and approval for site GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance issues.
Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning.
Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin, and particulate contamination.
Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level.
Provide technical guidance to the Process Team for sterility assurance programs and for root‑cause investigations related to sterility assurance programs.
Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance programs.
Basic Requirements
BS Degree required.
MS/PhD in a biological science preferred.
10+ years’ experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles.
10+ years’ experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.
Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g., filling technology, Annex 1 interpretation).
Minimum 3 years of management or leadership experience, including leading or working effectively with a cross‑functional group.
Teamwork and interpersonal skills.
Independent critical decision making, complex problem solving, and prioritization skills.
Multi‑tasking and communications skills.
Ability to influence diverse groups.
Additional Skills/Preferences
Proficiency in data analysis, ability to prioritize, attention to detail, critical decision‑making skills, complex problem‑solving abilities.
Strong written and oral communication skills.
Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology.
Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance.
Demonstrated experience influencing site and network leaders to advance technical agenda projects.
Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.
Strong capability to influence personnel and management across the organization.
Additional relevant experience (greater than 5 years) in any of the following associated disciplines such as Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories.
Experience with syringe technology and isolator filling technology.
Additional Information
Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and/or off‑hour work may be required.
Some travel may be required to other manufacturing sites and Lilly’s corporate office.
Compensation The anticipated wage for this position is $123,000 – $180,400.
Benefits Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). 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.
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.
Accommodation 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.
Seniority Level Director
Employment Type Full‑time
Job Function Other
Industries Internet News
#J-18808-Ljbffr
Associate Director – TSMS Sterility Assurance
role at
BioSpace
Company Overview 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 put people first and are looking for people who are determined to make life better for people around the world.
Responsibilities The Associate Director TS/MS – Sterility Assurance is responsible for the oversight of Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing. The role is responsible for leading and mentoring a technical staff and understanding parenteral aseptic processing as it relates to drug product manufacturing, specifically the formulation/filling/inspection of pharmaceutical products. The Associate Director will provide guidance on time management and priorities for direct reports and manage routine production support activities while balancing implementation of technical projects and program oversight.
This position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards related to sterility assurance. It also requires the ability to multitask/prioritize and excellent written and oral communication skills, decision‑making ability, interpersonal skills, and the ability to anticipate potential problems and develop/implement solutions. The role is expected to work with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plans, and quality objectives.
Key Objectives & Deliverables
Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
Technical and defendable contamination control strategy design and execution.
Performance management and development of staff.
Partner within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
Technical review and approval for site GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance issues.
Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning.
Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin, and particulate contamination.
Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level.
Provide technical guidance to the Process Team for sterility assurance programs and for root‑cause investigations related to sterility assurance programs.
Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance programs.
Basic Requirements
BS Degree required.
MS/PhD in a biological science preferred.
10+ years’ experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles.
10+ years’ experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.
Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g., filling technology, Annex 1 interpretation).
Minimum 3 years of management or leadership experience, including leading or working effectively with a cross‑functional group.
Teamwork and interpersonal skills.
Independent critical decision making, complex problem solving, and prioritization skills.
Multi‑tasking and communications skills.
Ability to influence diverse groups.
Additional Skills/Preferences
Proficiency in data analysis, ability to prioritize, attention to detail, critical decision‑making skills, complex problem‑solving abilities.
Strong written and oral communication skills.
Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology.
Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance.
Demonstrated experience influencing site and network leaders to advance technical agenda projects.
Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.
Strong capability to influence personnel and management across the organization.
Additional relevant experience (greater than 5 years) in any of the following associated disciplines such as Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories.
Experience with syringe technology and isolator filling technology.
Additional Information
Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and/or off‑hour work may be required.
Some travel may be required to other manufacturing sites and Lilly’s corporate office.
Compensation The anticipated wage for this position is $123,000 – $180,400.
Benefits Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). 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.
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.
Accommodation 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.
Seniority Level Director
Employment Type Full‑time
Job Function Other
Industries Internet News
#J-18808-Ljbffr