Lilly
Associate Director, Analytical/Micro QC Laboratories
Lilly, Indianapolis, Indiana, us, 46262
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.
Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Lilly CORE facility is a globally focused radiopharmaceutical manufacturing facility in Indianapolis, IN. At Lilly CORE, we are building a platform for the clinical development and commercialization of radioligands that fight cancer. These products aim to transform precision oncology by combining a portfolio of targeted radioligand assets, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177.
Position Summary:
Lilly CORE is seeking a Quality Control Laboratory Associate Director to lead all elements of our Quality Control laboratories, including Chemistry and Micro labs from method development/validation activities through regulatory registration and commercialization. This individual will manage all group activities of up to 30 QC staff which include supervisory levels to plan work for the group and respond to changing priorities while maintaining a safe, orderly, and compliant work area according to company safety standards and cGMP regulations. This individual will also represent the company with FDA and other Regulatory Agency officials related to QC expertise, as needed.
Responsibilities:
Key Objectives/Deliverables:
Manage for Results /Strategic Planning:
Direct all group activities of up to 30 QC staff and associated supervisors/managers.
Prioritize laboratory workload, re-prioritize as needed and ensure completion of all tasks.
Identify key process indicators and metrics to ensure the laboratory operates effectively and efficiently with a focus on Right First Time.
Identify analytical projects required to achieve group and corporate objectives. Plan and coordinate implementation of desired outcome(s). Strategize against corporate objectives.
Work independently but ensure communication of critical information upward with buy-in from senior management for key decision-making.
Evaluate, coach, and manage personnel performance. Set group objectives with management.
Participate in the budget process, including professional services. Monitor group spending to remain on track with budget.
Take initiative to make things better for the company, be aggressive with your work and assertive in your interactions, lead by example and build collaborative relationships.
Build a strong, responsive team that is reliable, responsive, and flexible to shifting demands.
Manage in alignment with the Lilly values of Integrity, Excellence, Respect for People.
Technical responsibilities:
Represent the department as a technical expert on the methods performed in the group and the results reported.
Conduct thorough document reviews, including submissions to global health authorities.
Respond effectively to any product or method-related trends.
Use scientific expertise to assist direct reports with troubleshooting, investigations, and problem resolution, including contract testing. Implement process improvements with senior leadership.
Apply strategic-thinking and forward planning with high level of ownership/accountability.
Ensure that all lab operations and documentation meet all quality and regulatory requirements.
Provide oversight and drive the reduction of analytical investigations and deviations while striving for operational excellence.
Compliance responsibilities:
Assure adherence to acceptable cGMP practices by staff during execution of all work tasks.
Review departmental documentation for conformance with global corporate policies and regulatory guidance.
Represent the company through effective interactions with all regulatory officials, as needed, related to QC expertise.
Manage Relationships with Key Stakeholders and Customers:
Interacts with local and global functional areas and external suppliers/agencies. Influences, negotiates, and makes decisions through those interactions.
Drives cross functional alignment and integration with Process Team.
Liaison between the Process Team and other site functional leaders.
Staff Development and Management:
Responsible for developing employees and future leaders.
Coach and mentor for internal resources.
Resource Management:
Fosters an inclusive workplace and engaged workforce.
Ensures effective hiring and staffing (right person for the right role).
Basic Requirements:
BS is required. Advanced scientific degree is preferred.
Position requires 3-5 years of leadership experience and 7-10 years of solid technical experience related to Chemical, Biologic, and or Microbiological testing of raw materials, drug substances and drug products.
Excellent working knowledge of cGMP regulations for QC laboratory applications is required.
Excellent teamwork and communication skills. Attentive to detail. Good computer skills.
Ability to take initiative, to be assertive, to lead by example and to build relationships.
Required to be on call outside of core business hours / days.
Additional Preferences:
Supervisory position with 3-5 years of previous management experience, or equivalent experience.
Physical Demands/Travel:
The physical demands of this job are consistent with a lab environment. 0-5% travel may be required. Lifting not required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is in a lab environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Lilly CORE facility is a globally focused radiopharmaceutical manufacturing facility in Indianapolis, IN. At Lilly CORE, we are building a platform for the clinical development and commercialization of radioligands that fight cancer. These products aim to transform precision oncology by combining a portfolio of targeted radioligand assets, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177.
Position Summary:
Lilly CORE is seeking a Quality Control Laboratory Associate Director to lead all elements of our Quality Control laboratories, including Chemistry and Micro labs from method development/validation activities through regulatory registration and commercialization. This individual will manage all group activities of up to 30 QC staff which include supervisory levels to plan work for the group and respond to changing priorities while maintaining a safe, orderly, and compliant work area according to company safety standards and cGMP regulations. This individual will also represent the company with FDA and other Regulatory Agency officials related to QC expertise, as needed.
Responsibilities:
Key Objectives/Deliverables:
Manage for Results /Strategic Planning:
Direct all group activities of up to 30 QC staff and associated supervisors/managers.
Prioritize laboratory workload, re-prioritize as needed and ensure completion of all tasks.
Identify key process indicators and metrics to ensure the laboratory operates effectively and efficiently with a focus on Right First Time.
Identify analytical projects required to achieve group and corporate objectives. Plan and coordinate implementation of desired outcome(s). Strategize against corporate objectives.
Work independently but ensure communication of critical information upward with buy-in from senior management for key decision-making.
Evaluate, coach, and manage personnel performance. Set group objectives with management.
Participate in the budget process, including professional services. Monitor group spending to remain on track with budget.
Take initiative to make things better for the company, be aggressive with your work and assertive in your interactions, lead by example and build collaborative relationships.
Build a strong, responsive team that is reliable, responsive, and flexible to shifting demands.
Manage in alignment with the Lilly values of Integrity, Excellence, Respect for People.
Technical responsibilities:
Represent the department as a technical expert on the methods performed in the group and the results reported.
Conduct thorough document reviews, including submissions to global health authorities.
Respond effectively to any product or method-related trends.
Use scientific expertise to assist direct reports with troubleshooting, investigations, and problem resolution, including contract testing. Implement process improvements with senior leadership.
Apply strategic-thinking and forward planning with high level of ownership/accountability.
Ensure that all lab operations and documentation meet all quality and regulatory requirements.
Provide oversight and drive the reduction of analytical investigations and deviations while striving for operational excellence.
Compliance responsibilities:
Assure adherence to acceptable cGMP practices by staff during execution of all work tasks.
Review departmental documentation for conformance with global corporate policies and regulatory guidance.
Represent the company through effective interactions with all regulatory officials, as needed, related to QC expertise.
Manage Relationships with Key Stakeholders and Customers:
Interacts with local and global functional areas and external suppliers/agencies. Influences, negotiates, and makes decisions through those interactions.
Drives cross functional alignment and integration with Process Team.
Liaison between the Process Team and other site functional leaders.
Staff Development and Management:
Responsible for developing employees and future leaders.
Coach and mentor for internal resources.
Resource Management:
Fosters an inclusive workplace and engaged workforce.
Ensures effective hiring and staffing (right person for the right role).
Basic Requirements:
BS is required. Advanced scientific degree is preferred.
Position requires 3-5 years of leadership experience and 7-10 years of solid technical experience related to Chemical, Biologic, and or Microbiological testing of raw materials, drug substances and drug products.
Excellent working knowledge of cGMP regulations for QC laboratory applications is required.
Excellent teamwork and communication skills. Attentive to detail. Good computer skills.
Ability to take initiative, to be assertive, to lead by example and to build relationships.
Required to be on call outside of core business hours / days.
Additional Preferences:
Supervisory position with 3-5 years of previous management experience, or equivalent experience.
Physical Demands/Travel:
The physical demands of this job are consistent with a lab environment. 0-5% travel may be required. Lifting not required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is in a lab environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
#J-18808-Ljbffr