Assoc Consultant Biologist-QC
Eli Lilly and Company, Indianapolis, IN, United States
Position Brand Description
The Associate Consultant Biologist for QC commercialization support commercialization activities for laboratories within Indianapolis Parenteral Manufacturing. Responsibilities include method transfers, validations, or verifications of new molecules, collaboration with global analytical stewards, local change controls, and following Laboratory Quality Systems (LQS) and Global Quality Systems (GQS) for Parenteral QC. Serve as a local data steward / laboratory key site contact for global site impacts.
Responsibilities
Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
Champion for Site Impact Assessment for Compendial and GQS updates.
Act as local data steward / laboratory key site contact for new molecule implementation in the laboratory.
Lead / Supervise method transfers, validations, or verifications for new molecules in the laboratory.
Author technical documents to support commercialization, method transfers, validations or verifications, as applicable. Author change controls to support commercialization, new methods, new reference standards, etc.
Participate in APLOT and commercialization meetings.
Complete steps for global changes, as applicable.
Support global analytical stewards by gathering information on new methods.
Work closely with GQL and PR&D to help guide and provide expectation was it relates to new methods.
Support audit activities.
Local technical SME for all micro methods.
Method management for respective IPM Laboratories.
Technical review, interpretation and release of data including CoT issuance, stability results and reference standard characterization.
Perform technical training.
Coach lab analysts in real time.
Mentor analysts through formal process / program.
Review and approve change controls and deviations.
Review and interpret data and document results of analyses and conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines.
Develop investigational testing protocols and perform testing as required.
Method validation / remediation.
Research and recommend new technologies.
Basic Requirements
BSc or MSc in scientific or technical degree: chemistry, biology, engineering, or equivalent scientific / technical degree.
20+ years of experience in a GMP QC laboratory and/or pharmaceutical industry.
Demonstrated ability to lead projects.
Experience supporting regulatory inspections.
Strong influencing skills and interpersonal and teamwork skills.
Both strong technical writing and communication skills.
Strong self-management and organizational skills.
Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
Additional Skills/Preferences
Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic and / or microbiological assays.
Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
Deep understanding of compliance requirements and regulatory expectations.
Additional Information
Ability to work 8 hour days – Monday through Friday.
Ability to cover weekends, holidays, and company shutdowns as needed.
Minimal travel required.
Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
Tasks may require repetitive motion (e.g., keyboarding).
Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400. 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.
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. Lilly reserves the right to demonstrate compliance with all relevant equal opportunity and anti-discrimination laws and provide equal opportunity to all qualified candidates and employees.
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Responsibilities
Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
Champion for Site Impact Assessment for Compendial and GQS updates.
Act as local data steward / laboratory key site contact for new molecule implementation in the laboratory.
Lead / Supervise method transfers, validations, or verifications for new molecules in the laboratory.
Author technical documents to support commercialization, method transfers, validations or verifications, as applicable. Author change controls to support commercialization, new methods, new reference standards, etc.
Participate in APLOT and commercialization meetings.
Complete steps for global changes, as applicable.
Support global analytical stewards by gathering information on new methods.
Work closely with GQL and PR&D to help guide and provide expectation was it relates to new methods.
Support audit activities.
Local technical SME for all micro methods.
Method management for respective IPM Laboratories.
Technical review, interpretation and release of data including CoT issuance, stability results and reference standard characterization.
Perform technical training.
Coach lab analysts in real time.
Mentor analysts through formal process / program.
Review and approve change controls and deviations.
Review and interpret data and document results of analyses and conclusions accurately and thoroughly in summary reports in accordance with GMP and local guidelines.
Develop investigational testing protocols and perform testing as required.
Method validation / remediation.
Research and recommend new technologies.
Basic Requirements
BSc or MSc in scientific or technical degree: chemistry, biology, engineering, or equivalent scientific / technical degree.
20+ years of experience in a GMP QC laboratory and/or pharmaceutical industry.
Demonstrated ability to lead projects.
Experience supporting regulatory inspections.
Strong influencing skills and interpersonal and teamwork skills.
Both strong technical writing and communication skills.
Strong self-management and organizational skills.
Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
Additional Skills/Preferences
Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic, spectroscopic and / or microbiological assays.
Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
Deep understanding of compliance requirements and regulatory expectations.
Additional Information
Ability to work 8 hour days – Monday through Friday.
Ability to cover weekends, holidays, and company shutdowns as needed.
Minimal travel required.
Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
Tasks may require repetitive motion (e.g., keyboarding).
Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400. 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.
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. Lilly reserves the right to demonstrate compliance with all relevant equal opportunity and anti-discrimination laws and provide equal opportunity to all qualified candidates and employees.
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