Senior Scientist, Downstream Process Development
Indianaagconnection
- Senior Scientist, Downstream Process DevelopmentBack to search resultsApply to this positionFollow CompanyMore Jobs from ElancoSend to Friend**At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.** **At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.** **At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.** **Making animals' lives better makes life better - join our team today!** **Your Role: Senior Scientist, Downstream Process Development** Elanco is seeking a Senior Scientist, Downstream Process Development to lead purification process development for biologic drug substances, with a focus on monoclonal antibodies, therapeutic proteins, and mammalian cell culture-derived biologics. This role will support programs from bench and pilot scale through process scale-up, technology transfer, process characterization, GMP manufacturing implementation, clinical material production, and CMC/regulatory filing support. The ideal candidate will have hands-on experience developing and optimizing downstream purification processes, including chromatography and filtration-based unit operations such as Protein A or affinity chromatography, ion exchange chromatography, polishing steps, viral clearance or viral inactivation, depth filtration, UF/DF, TFF, and scale-down model development. You will partner closely with R&D, TS/MS, Manufacturing, Quality, Supply Chain, Regulatory, and external CDMOs to ensure successful process transfer, implementation, and commercialization. This role requires strong technical judgment, clear communication, and the ability to lead cross-functional work in a fast-paced biologics development environment. **Your Responsibilities** * Lead downstream process development for early- and late-stage biologic programs, including monoclonal antibodies, therapeutic proteins, and other biologic modalities.* Develop and optimize purification processes using phase-appropriate strategies, QbD principles, and process characterization approaches.* Design and execute bench- and pilot-scale studies, including scale-down model development, process scale-up, and manufacturing support.* Support risk assessments, control strategy development, stage-gate reviews, and technical decision-making for biologic drug substance programs.* Author and review technical reports, process development documents, tech transfer packages, and CMC source documents for regulatory submissions.* Support responses to CMC questions from regulatory agencies.* Partner with R&D, TS/MS, Manufacturing, Quality, Supply Chain, Regulatory, Launch Teams, and external CDMOs to ensure successful tech transfer, clinical material production, and commercialization.* Serve as a downstream process development subject matter expert for internal teams, manufacturing sites, and external partners. **What You Need to Succeed** * MSc or PhD in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or a related scientific discipline. Equivalent experience may be considered.* PhD with 7+ years or MSc with 12+ years of experience in downstream biologics process development, preferably with mammalian cell culture-derived biologic products.* Hands-on experience developing and optimizing downstream purification processes for biologic drug substances, including monoclonal antibodies, therapeutic proteins, or other protein-based biologic modalities.* Experience supporting late-stage development, process scale-up, technology transfer, and implementation into GMP manufacturing.* Experience contributing to CMC/regulatory filing activities, including technical reports, source documents, process descriptions, tech transfer documents, or responses to regulatory agency questions.* Strong understanding of downstream unit operations such as chromatography, filtration, UF/DF, TFF, polishing steps, viral clearance or viral inactivation, process characterization, and scale-down model development. **What Will Give You a Competitive Edge** * Strong understanding of GMP, Quality by Design, process characterization, control strategy development, and risk assessment principles.* Demonstrated success developing, scaling, transferring, or commercializing biologics, pharmaceuticals, vaccines, or other complex biological products.* Experience working with internal manufacturing teams, TS/MS, Quality, Regulatory, Supply Chain, Launch Teams, and external CDMOs.* Strong interpersonal and leadership skills, with the ability to influence stakeholders and lead cross-functional technical teams.* Ability to manage multiple priorities, navigate ambiguity, and communicate complex technical information through clear writing and presentations.* Experience with AI/ML applications in process development is a plus.* Animal health experience is advantageous but not required. **Additional Information:** * **Travel:** 10-20% (domestic and international)* **Location:** Indianapolis, IN - Hybrid Work Environment **Elanco Benefits and Perks :** We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: * 8-week parental leave * 9 Employee Resource Groups * Annual bonus offering * Up to 6% 401K matching Don't meet every single requirement?Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! **Elanco Benefits and Perks:** We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: • Multiple relocation packages • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) • 8-week parental leave • 9 Employee Resource Groups • Annual bonus offering • Flexible work arrangements • Up to 6% 401K matching Elanco 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 Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice. Elanco 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 Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.To apply please click on APPLY TO THIS POSITION
- J-18808-Ljbffr Indianaagconnection
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior Scientist, Downstream Process Development in Indianapolis, IN vacancy
- Elanco is seeking a Senior Scientist for Downstream Process Development in Indianapolis. This role involves leading purification process development for biologic drugs, including monoclonal antibodies. The ideal candidate will have substantial hands-on experience and will...Senior
- ...will propel your career to new heights. Making animals’ lives better makes life better - join our team today! Senior Scientist, Downstream Process Development We are seeking a Senior Scientist, Downstream Process Development to lead purification process development for...SeniorSummer workLocal areaRelocationFlexible hours
- ...your career to new heights. Making animals’ lives better makes life better - join our team today! Your Role: Senior Scientist, Downstream Process Development The Biopharma Technical Development team located in Indianapolis, IN is seeking a Senior Research Scientist to...SeniorSummer workRelocationFlexible hours
- Genezen is seeking a Sr/Principal Scientist for Upstream Process Development in Indianapolis, IN. This role involves managing a team and overseeing upstream process development, technology transfer, and GMP manufacturing support. The ideal candidate will have an MSc or...Senior
- ...Sr/Principal Scientist - Upstream Process Development Indianapolis, IN The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction...SeniorTemporary workFor contractorsWork experience placementVisa sponsorship
Genezen
Indianapolis, IN2 days ago $101.25k - $169.4k
...role is within Bioproduct Research and Development (BR&D), a multidisciplinary organization... ...derived products. Upstream Process Development engineers develop and optimize... ...to work independently and mentor junior scientists in a collaborative, cross‑functional environment...Full timeCasual workH1bVisa sponsorshipWork visaFlexible hoursBioSpace, Inc.
Indianapolis, IN2 days ago$65.25k - $169.4k
...Position Summary The Bioproduct Research and Development (BR&D) organization strives to deliver... ...and quality, business units. The Principal Scientist/Sr. Principal Scientist is responsible for upstream process development activities related to the production...Full timeTemporary workH1bVisa sponsorshipWork visaFlexible hoursEli Lilly
Indianapolis, IN3 days ago- Lilly is seeking a Senior Analytical Scientist to lead analytical characterization efforts at the Lilly Medicine Foundry in Indianapolis. You will implement solutions and support drug production processes through collaboration with engineering teams. The ideal candidate...Senior
- Initial Therapeutics, Inc. is seeking a Senior Scientist in Indianapolis, IN to provide technical support for manufacturing Active Pharmaceutical... ...Ingredients (APIs). This role involves technology transfer, process validation, and continuous optimization of manufacturing...Senior
- Position Description As the Formulations Senior Research Scientist, you will develop robust formulations and manufacturing processes needed to advance Elanco’s biopharmaceutical... ...to predict stability and streamline development timelines. It includes establishing formulation...SeniorSummer workRelocationFlexible hours
$118k - $197k
...dedicated regulatory expert on global project teams, shaping development from the ground up and leading direct negotiations with agencies... ...animal products. Broad experience with global registration processes, particularly leading first‑wave submissions in the European Union...SeniorSummer workLocal areaRemote workRelocationFlexible hours$68.5k - $88.02k
...developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards... ...projects or tasks as necessary based on skill set and/or development goals and business needs. Performs other job duties as assigned...SeniorTemporary workWork experience placementWork at officeLocal areaImmediate startFlexible hoursNight shiftAfternoon shift$156k - $228.8k
A global healthcare leader in Indianapolis is seeking a Senior Director, ADC Process Development, to lead a team focused on delivering their Antibody-Drug Conjugate portfolio. The role involves developing strategies for small molecule processes and leading cross-functional...Senior- A global leader in animal health seeks a Senior Research Scientist in Indianapolis. This role involves advancing analytical methods for drug development, ensuring compliance with regulatory standards. Candidates should have a PhD in a relevant field and strong expertise...Senior
- ...Molecular Biologist - (Research & Development Technology Hub) Team... ...future projects to automate processes which are currently manual.... ...isolation of high quality PBMCs for downstream research applications.... .... Regularly interfaces with scientists from different research areas...Temporary workWork at officeWorldwide
ATL, A Bureau Veritas Company
Indianapolis, IN5 days ago - ...studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly... ..., seals, tubing, etc.) Experience with chromatography data processing software (e.g. Empower) Verify system readiness for open access...SeniorFull timeContract workWeekend work
$58k - $123.2k
...position sits within the Purification Process Development group in BR&D and focuses on advancing... ...postdoc will work at the intersection of downstream purification, conjugation chemistry,... ..., and mentorship from Lilly’s leading scientists, aimed at facilitating groundbreaking...Full timeTemporary workFlexible hours$169.8k - $355.4k
...opportunity to work with teams of applied scientists and engineers to deliver high quality... ...will be responsible for driving the development and implementation of cutting-edge computer... ...vision, deep learning, and image processing Proven track record of leading research...SeniorTemporary workFlexible hoursOracle
Indianapolis, IN5 days ago- Lilly, located onsite in Indianapolis, seeks a Senior Scientist for the API-EM program to provide technical expertise in small molecule manufacturing, process transfers, validations, and optimization. The role requires GMP knowledge, regulatory understanding, and leadership...Senior
$156k - $228.8k
Senior Director, ADC Process Development At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare... ...Development, to lead and expand our growing team of scientists and engineers focused on delivering Lilly’s Antibody‑...SeniorTemporary workFlexible hours$65.25k - $169.4k
BioSpace is looking for a Principal Scientist/Sr. Principal Scientist in Indianapolis, Indiana, to lead upstream process development for bioproducts. The role requires significant experience in the field and demands effective collaboration with cross-functional teams in...Senior- Position Description As the Formulations Senior Research Scientist, you will develop robust formulations and manufacturing processes needed to advance Elanco’s biopharmaceutical... ...to predict stability and streamline development timelines. This role involves establishing...SeniorContract workSummer workRelocationFlexible hours
$66k - $171.6k
...around the world. Job Description: The Senior Scientist - Manufacturing Science provides the... ...data analysis) to improve and optimize process control, yield, purity, and/or productivity... ...Control, Quality Assurance, or Development. Qualified applicants must be authorized...SeniorFull timeH1bLocal areaVisa sponsorshipWork visaFlexible hours- ...and experience in one or more of the following: environmental process, NEPA environmental document preparation, stream/wetland delineation... ...with local, regional, or state agencies. Business development skills and the proven ability to win work. Experience with NEPA...Work at officeLocal areaFlexible hours
Kimley-Horn
Indianapolis, IN1 day ago $68.5k - $88.02k
...responsible for cost of production and maintenance activities including process improvement, supply chain management, quality assurance,... ...timely and effective closure. May contribute to the development of policies and procedures directly impacting radiopharmaceutical...SeniorFull timeTemporary workWork experience placementWork at officeLocal areaImmediate startMonday to FridayFlexible hoursAfternoon shift- ...Senior Medical Technologist Labcorp is a global leader in laboratory services, providing... .... Coordinates the timely development and completion of training materials and... ...SOPs or writes new SOPs to reflect current processes that ensure compliance. Coordinates with...SeniorTemporary workCasual workInternshipLocal areaRelocation packageMonday to FridayFlexible hoursShift work
LabCorp
Indianapolis, IN7 hours ago - ...Therapeutics, Inc. is seeking a postdoctoral candidate to advance In-Process Conjugation as a manufacturing platform for Antibody RNA... ...strong collaboration skills and experience in purification development. The position is based in Indianapolis, Indiana, and includes...
$65.25k - $169.4k
Organizational Overview Synthetic Molecule Design and Development (SMDD) is a critical function within Lilly Product Research & Development... ...from the pre‑clinical phase through commercialization. Process chemistry is crucial to establishing a robust and sustainable...Full timeH1bLocal areaVisa sponsorshipWork visaFlexible hours$163.5k - $239.8k
...Solutions (DDCS) organization supports the design, development, and commercialization of drug products and pharmaceutical... ...offers the scope and the platform to shape it. The Senior Director - Embedded Systems and Process Engineering (ESPE) provides functional and strategic...SeniorFull timeFlexible hours$65.25k - $169.4k
...Lilly’s Synthetic Molecule Design and Development (SMDD) is involved in key activities for... ...oligonucleotides, and synthetic peptides. Our scientists develop key technical and business... ...Chemical Hazards Lab (CHL) within the Process Design and Development division of...Full timeH1bVisa sponsorshipWork visaFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Scientist, Downstream Process Development. Be the first to apply!
Related searches
- protein scientist Indianapolis, IN
- applied sports scientist Indianapolis, IN
- deep learning scientist Indianapolis, IN
- lab scientist Indianapolis, IN
- molecular biology scientist Indianapolis, IN
- senior analytical scientist Indianapolis, IN
- decision scientist Indianapolis, IN
- senior research scientist Indianapolis, IN
- scientist assay development Indianapolis, IN
- scientist immunology Indianapolis, IN