BioSpace
Advisor/Sr. Advisor, Downstream Purification Development
BioSpace, Indianapolis, Indiana, us, 46262
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Advisor/Senior Advisor Downstream Purification Development
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Overview Bioproduct Research and Development (BRD) is the large-molecule process development organization within Lilly. BRD is responsible for material and data generation to support clinical trials and commercialization of biologic therapeutics such as mAbs and bioconjugates. Our team works to accelerate the development and manufacturing of new bioconjugate medicines for our patients. We perform innovative and cutting-edge research to deliver bioconjugation processes, knowledge, and best practices to support clinical trials and commercialization for antibody-drug conjugates (ADCs), antibody-peptide conjugates (APCs), and antibody-RNA conjugates (ARCs/AOCs). We collaborate with our Synthetic Molecule Design and Development (SMDD), discovery, and biologics development colleagues to advance this exciting class of new drugs and seek fundamental learning and platform approaches to their development.
Position Summary The scientist is responsible for leading teams of scientists and engineers in the development and optimization of purification processes for the production of recombinant therapeutic proteins as well as for process control strategy development, process scale-up and technology transfer to pilot plant and manufacturing sites. The scientist is also responsible for leading/supporting organizational strategic initiatives, evaluating and/or installing new capabilities/technologies and leveraging internal and external influence to solve problems and benchmark potential solutions.
Responsibilities
Lead the design, execution and interpretation of appropriate purification development experiments to drive the definition and optimization of downstream processes for the generation of recombinant protein active pharmaceutical ingredients.
Use first principles and designed experiments (DOE) to predict/understand/control the impact of physical and chemical processing conditions on recombinant protein product quality.
Lead the development of validated scaled-down models of key bioprocess unit operations including: filtration/TFF, chromatography operations and freeze/thaw.
Participate in and/or lead cross-functional process development teams and effectively collaborate with other groups in Bioprocess and Bioproduct Development, Discovery, Technical services for Manufacturing and Manufacturing.
Support transfer of purification processes to Technical services for Manufacturing laboratories and pilot plant/manufacturing sites.
Authorship of technical reports and regulatory documents.
Work effectively with external parties on development projects, research collaborations and outsourcing efforts.
Lead/support implementation of organizational strategic initiatives in support of the Lilly pipeline.
Keep abreast of relevant scientific literature and new technologies/capabilities and regulatory initiatives/requirements. Lead implementation, as appropriate.
Leverage internal and external influence to solve problems and benchmark potential solutions.
Provide coaching, training and administration of performance management to personnel (primarily, but not limited to, direct reports).
Ensure work and team activities are aligned with all relevant Development Quality, regulatory, HSE, GLP and GMP requirements.
Basic Requirements
Ph.D. in Biochemistry, Chemistry, or related field.
General knowledge and understanding of issues associated with scaling of protein purification processes and use of statistics for data analysis.
Additional Preferences
Exceptional problem solving and decision-making skills.
Demonstration of scientific and people leadership skills.
Effective oral and written communication skills.
Must be able to work productively in an interdisciplinary team environment.
Physical Demands/Travel The physical demands of this job are consistent with a lab environment.
Work Environment This position’s work environment is in a laboratory environment.
EEO & Disability 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 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.
Compensation & Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600 . 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).
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Advisor/Senior Advisor Downstream Purification Development
role at
BioSpace . Get AI-powered advice on this job and more exclusive features.
Overview Bioproduct Research and Development (BRD) is the large-molecule process development organization within Lilly. BRD is responsible for material and data generation to support clinical trials and commercialization of biologic therapeutics such as mAbs and bioconjugates. Our team works to accelerate the development and manufacturing of new bioconjugate medicines for our patients. We perform innovative and cutting-edge research to deliver bioconjugation processes, knowledge, and best practices to support clinical trials and commercialization for antibody-drug conjugates (ADCs), antibody-peptide conjugates (APCs), and antibody-RNA conjugates (ARCs/AOCs). We collaborate with our Synthetic Molecule Design and Development (SMDD), discovery, and biologics development colleagues to advance this exciting class of new drugs and seek fundamental learning and platform approaches to their development.
Position Summary The scientist is responsible for leading teams of scientists and engineers in the development and optimization of purification processes for the production of recombinant therapeutic proteins as well as for process control strategy development, process scale-up and technology transfer to pilot plant and manufacturing sites. The scientist is also responsible for leading/supporting organizational strategic initiatives, evaluating and/or installing new capabilities/technologies and leveraging internal and external influence to solve problems and benchmark potential solutions.
Responsibilities
Lead the design, execution and interpretation of appropriate purification development experiments to drive the definition and optimization of downstream processes for the generation of recombinant protein active pharmaceutical ingredients.
Use first principles and designed experiments (DOE) to predict/understand/control the impact of physical and chemical processing conditions on recombinant protein product quality.
Lead the development of validated scaled-down models of key bioprocess unit operations including: filtration/TFF, chromatography operations and freeze/thaw.
Participate in and/or lead cross-functional process development teams and effectively collaborate with other groups in Bioprocess and Bioproduct Development, Discovery, Technical services for Manufacturing and Manufacturing.
Support transfer of purification processes to Technical services for Manufacturing laboratories and pilot plant/manufacturing sites.
Authorship of technical reports and regulatory documents.
Work effectively with external parties on development projects, research collaborations and outsourcing efforts.
Lead/support implementation of organizational strategic initiatives in support of the Lilly pipeline.
Keep abreast of relevant scientific literature and new technologies/capabilities and regulatory initiatives/requirements. Lead implementation, as appropriate.
Leverage internal and external influence to solve problems and benchmark potential solutions.
Provide coaching, training and administration of performance management to personnel (primarily, but not limited to, direct reports).
Ensure work and team activities are aligned with all relevant Development Quality, regulatory, HSE, GLP and GMP requirements.
Basic Requirements
Ph.D. in Biochemistry, Chemistry, or related field.
General knowledge and understanding of issues associated with scaling of protein purification processes and use of statistics for data analysis.
Additional Preferences
Exceptional problem solving and decision-making skills.
Demonstration of scientific and people leadership skills.
Effective oral and written communication skills.
Must be able to work productively in an interdisciplinary team environment.
Physical Demands/Travel The physical demands of this job are consistent with a lab environment.
Work Environment This position’s work environment is in a laboratory environment.
EEO & Disability 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 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.
Compensation & Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600 . 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).
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