Senior Bioprocessing Associate - Downstream at Umoja Biopharma | Louisville, CO

Umoja Biopharma stands at the forefront of biotechnology, with state-of-the-art facilities in Seattle, WA, and Louisville, CO. We are dedicated to pioneering innovative treatments for cancer via our unique integrated immunotherapy platform. Our mission is to create versatile therapies that can target any tumor, at any time. As a diverse and rapidly expanding team, we invite visionary thinkers passionate about groundbreaking science and technology to join us in overcoming the challenges of advanced drug development. We uphold core values that align with our mission and encourage applications from candidates who share our commitment to enhancing patient outcomes.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYWe are on the lookout for a driven and skilled Senior Bioprocessing Associate to bolster the downstream Manufacturing Operations at our GMP manufacturing facility specializing in cell/gene therapy in Louisville, CO. This pivotal role will focus on the downstream purification processes while also supporting various manufacturing functions.Key responsibilities include executing buffer preparation, chromatography, and TFF batch records, managing materials, overseeing personnel gowning, ensuring compliance with personnel/material flow, conducting facility cleaning, onboarding new manufacturing processes/products, and aiding in the establishment of facility quality systems. Success in this position is defined by achieving full qualification on downstream manufacturing unit operations and effectively producing lentiviral drug products.This role involves regular interaction with internal process engineers, Process Sciences, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control teams. Strong communication skills are essential for effective collaboration within our matrix team environment. This is an exciting opportunity to contribute to a talented team focused on successfully targeting solid tumors with innovative cell/gene therapies.This position is fully onsite at our Louisville, CO location and will initially require a commitment of 5 days a week, transitioning to a 4x10 schedule after completing onboarding and training.

Umoja Biopharma stands at the forefront of biotechnological innovation, with state-of-the-art facilities in Seattle, WA and Louisville, CO. Our mission is to revolutionize cancer treatment through our pioneering immunotherapy platform, which seeks to provide off-the-shelf solutions for various tumors anytime. As a diverse and expanding team, we thrive in our modern workspaces and are on the lookout for forward-thinking individuals who are driven by scientific breakthroughs and eager to tackle the complexities of advanced drug development. We value our core principles and actively encourage applications from passionate candidates who share our vision, helping us fulfill our mission of delivering hope and healing to patients and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYWe are excited to announce an opening for a dedicated Bioprocessing Associate I to join our Manufacturing Drug Substance (DS) and Drug Product (DP) Operations at our newly established GMP manufacturing facility in Louisville, CO. In this role, you will primarily focus on the DS/DP Fill and Visual Inspection operations, while also supporting various other manufacturing tasks as needed. Key responsibilities include onboarding manufacturing equipment, managing materials, ensuring personnel gowning protocols, executing batch records, conducting aseptic processing, integrating new manufacturing processes/products, and contributing to the establishment of facility quality systems. Success in this position will be measured by your ability to achieve successful aseptic manufacturing training and qualification, directly contributing to the creation of Phase 1 lentiviral drug products. You will collaborate closely with internal process engineers, facilities management, warehouse/supply chain, EHS, Quality Assurance, and Quality Control teams. Excellent communication skills are vital for effectively navigating our collaborative team environment.This is an exceptional opportunity to join a dynamic team in an exhilarating setting, committed to overcoming the challenges of effectively targeting solid tumors with innovative cell and gene therapies.This position will be fully onsite at our Louisville, CO location with a schedule of either Monday-Thursday or Tuesday-Friday, operating on a 4x10 schedule. Flexibility to accommodate operational needs is essential.

About Umoja Biopharma Umoja Biopharma is a biotech company focused on advancing cancer treatment. With facilities in Seattle, WA, and Louisville, CO, Umoja develops integrated immunotherapy platforms aimed at delivering off-the-shelf therapies for a wide range of tumors. The team values diversity and a shared commitment to progress in drug development. Role Overview: Senior Calibration Technician This on-site position is based in Louisville, Colorado, and requires presence at the facility five days a week. The Senior Calibration Technician will support the calibration and maintenance of measurement instruments at Umoja's lentiviral vector development and manufacturing site. Main Responsibilities Perform routine and non-routine calibrations for production, laboratory, and facility operations. Independently execute calibrations for parameters such as conductivity, pH, pressure, flow, temperature, speed, and mass. Work within GxP and company quality standards. Troubleshoot complex calibration or instrumentation issues and take initiative in problem-solving. Oversee and coordinate with external service providers to ensure compliance with Umoja's standards. What Umoja Biopharma Looks For Ability to work independently with minimal supervision. Strong problem-solving skills and initiative. Experience with calibration and maintenance of measurement instruments in a regulated environment. Commitment to quality and compliance. Umoja Biopharma – Your Body. Your Hope. Your Cure.

Umoja Biopharma stands at the forefront of biotechnology, with vibrant locations in Seattle, WA, and Louisville, CO. We are dedicated to revolutionizing cancer treatment through our innovative integrated immunotherapy platform. Our mission is to develop off-the-shelf therapies that are effective against any tumor, at any time. As a diverse and expanding team situated in state-of-the-art facilities in downtown Seattle and Louisville, we are seeking creative minds who are inspired by groundbreaking science and technology. If you are passionate about tackling the challenges of cutting-edge drug development, we encourage you to apply and join us in our commitment to enhancing patient care. At Umoja, we value storytelling and are eager to create meaningful narratives for our patients and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYWe are looking for an experienced Senior Enterprise Systems Analyst to enhance and support our portfolio of enterprise applications. This role will act as a subject matter expert across systems that support Supply Chain, Finance, Accounting, Procurement, HR, and Quality. You will manage daily system operations, resolve issues, and lead the implementation of new capabilities. Collaborating with cross-functional teams, you will convert business needs into technical solutions, drive process enhancements, support projects from design to execution, and ensure regulatory compliance in our dynamic biotech environment. While you will primarily oversee NetSuite, you will also administer and support additional enterprise applications throughout the organization.This role is based in our Louisville, CO site, and candidates are expected to work onsite at least 3 days a week.

At Umoja Biopharma, an innovative leader in biotechnology, our mission is to revolutionize cancer treatment through a pioneering integrated immunotherapy platform. With facilities located in Seattle, WA, and Louisville, CO, we are dedicated to developing off-the-shelf therapies that can address any tumor at any time. Our diverse and expanding team is situated in state-of-the-art facilities in both cities, and we are eager to welcome innovative thinkers who are passionate about advancing groundbreaking science and technology and tackling the challenges of cutting-edge drug development. We invite enthusiastic individuals who share our commitment to join us in our mission to create impactful stories, not just for ourselves, but for patients and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYWe are on the lookout for a dedicated and skilled Bioprocessing Associate II to support our Manufacturing Drug Substance (DS) and Drug Product (DP) Operations at our newly established GMP manufacturing facility in Louisville, CO. This role focuses on routine DS/DP Operations, particularly in the areas of DS/DP Fill & Visual Inspection, with potential involvement in various manufacturing functions.Key responsibilities include, but are not limited to: onboarding and qualification of manufacturing equipment, management of materials, personnel gowning, implementing personnel/material flow, executing batch records, aseptic processing, vial visual inspection, onboarding new manufacturing processes/products, and aiding in the establishment of facility quality systems. Success will be measured by the effective training/qualification in aseptic manufacturing and the successful execution of phase 1 lentiviral drug products. This position requires regular interaction with internal process engineers, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control teams. Strong communication skills are vital for effective collaboration within our matrix team environment.This is a fantastic opportunity to be part of a dynamic team working in a stimulating environment, dedicated to the successful targeting of solid tumors using novel cell/gene therapies.This role is fully onsite at our Louisville, CO facility, with a schedule of either Monday-Thursday or Tuesday-Friday.

About Umoja Biopharma Umoja Biopharma is a biotechnology company with offices in Seattle, WA and Louisville, CO. The team focuses on advancing integrated immunotherapy platforms, aiming to create off-the-shelf therapies for a broad range of tumors. Umoja operates out of modern facilities and values diverse perspectives in science and technology. The company welcomes those eager to contribute to the future of cancer treatment and to make a difference for patients and their families. Role Overview The Bioprocessing Specialist, Drug Product, will join the Manufacturing Operations group at Umoja’s new early-stage cell and gene therapy GMP facility in Louisville, CO. This fully onsite position supports the development and implementation of Drug Substance (DS) and Drug Product (DP) processes. Key Responsibilities Onboard, qualify, and manage DS/DP processing equipment Handle material management and personnel gowning Oversee facility cleaning Author, review, and execute batch records Coordinate production scheduling Train and provide leadership to staff Perform aseptic processing and vial visual inspection Support onboarding of new manufacturing processes and products Collaborate with internal teams: process engineering, process sciences, facilities, warehouse/supply chain, EHS, Quality Assurance, and Quality Control Strong communication skills are important for success in this matrixed team structure. Schedule and Work Environment Full-time, onsite in Louisville, CO 4x10 schedule: Monday-Thursday or Tuesday-Friday Flexibility required for weekends, holidays, or evenings as needed

Umoja Biopharma is a pioneering biotechnology firm with cutting-edge facilities in Seattle, WA, and Louisville, CO, dedicated to revolutionizing cancer treatment through an innovative integrated immunotherapy platform. Our mission is to create off-the-shelf therapies that can address any tumor at any moment. We pride ourselves on our diverse and expanding team, and we are seeking inventive minds who are inspired by transformative science and technology and are ready to tackle the complexities of advanced drug development. At Umoja, we value the power of stories, and we invite passionate individuals to join our team to help us craft compelling narratives for ourselves, our colleagues, and, most importantly, for patients and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYWe are looking for a motivated Associate Scientist II to join our Analytical Development organization within the Process Analytics department. This role involves delivering routine UPLC analytical methods and transferring or developing separation techniques to quantify residual process reagents in our lentiviral vector (VivoVec) Drug Product and in-process samples. Additionally, you will engage in new method development aimed at enhancing product quality understanding. Early phase validation and the transfer of these methods to Quality Control are essential to facilitate the release testing of GMP lots.The ideal candidate will have a strong background in chromatography systems and various detection methods. You will work independently to meet deadlines, demonstrating a keen attention to detail and ensuring thorough documentation of experimental procedures in an Electronic Laboratory Notebook (ELN). Contributing to report writing is also part of this role, which involves collaboration with other departments to support the development and successful transfer of qualified methods to QC Analytical.This position requires full onsite presence five days a week, primarily lab-based at our Louisville, CO location.

Umoja Biopharma is a pioneering biotechnology company with locations in Seattle, WA and Louisville, CO, dedicated to revolutionizing cancer treatment through our innovative integrated immunotherapy platform. We aspire to create off-the-shelf therapies that can address any tumor at any time. Our diverse and expanding team operates in state-of-the-art facilities located in downtown Seattle, Washington, and Louisville, Colorado. We seek imaginative thinkers who are passionate about groundbreaking science and technology, and who are eager to tackle the challenges associated with advanced drug development. Our firm commitment to our core values and principles drives our mission, and we warmly encourage applications from enthusiastic individuals who share our vision and can help position Umoja to achieve its objectives. At Umoja, we value the power of stories; we are searching for exceptional talent to join us in crafting more impactful narratives for ourselves, our team, and most crucially, for patients and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYWe invite applications for the role of Associate Manager to lead Purification Operations within our Manufacturing team at our early-stage cell/gene therapy GMP manufacturing facility in Louisville, CO.In this role, you will be responsible for directing operations and driving continuous improvement initiatives across manufacturing programs and operating systems in downstream processing and solution preparation. Key responsibilities include, but are not limited to, onboarding new hires, developing personnel, executing purification unit operations, maintaining equipment, managing materials, overseeing personnel gowning protocols, implementing personnel/material flow, reviewing batch records, scheduling production, onboarding new manufacturing processes/products, and supporting the implementation of quality systems at our facility. Your success will be evaluated based on effective downstream execution, ensuring adequate personnel coverage, fostering employee development, and driving continuous improvement initiatives.This position will require regular interaction with internal process engineers, process sciences, facilities, supply chain, EHS, quality assurance, and quality control teams. Strong communication skills are essential for effective collaboration within this matrixed environment.This is an exciting opportunity to join a dynamic team focused on the challenge of successfully targeting solid tumors with novel cell/gene therapies.This role is fully onsite at our Louisville, CO location. The work schedule will be determined upon the offer extension and may be either Monday-Friday, 8 am to 5 pm or an alternative shift.

About Umoja Biopharma Umoja Biopharma is a biotechnology company focused on advancing cancer treatment through integrated immunotherapy. With facilities in Seattle, WA, and Louisville, CO, the team works to develop off-the-shelf therapies aimed at treating a wide range of tumors. Umoja values collaboration, scientific rigor, and a commitment to improving patient outcomes. The company welcomes individuals who share its mission and values. Role Overview: Senior Research Associate, Analytical Development The Senior Research Associate will join the Analytical Development team, working within the Process Analytics sub-team. This full-time, on-site position is based in Louisville, CO, and requires laboratory attendance five days a week. Key Responsibilities Support in-process testing of Lentiviral Vector (LVV) drug substances and products. Perform routine sample testing and contribute to the development of new analytical methods. Manage the lifecycle of existing analytical methods. Enhance assay execution, data quality, and turnaround time through automation, including the use of AI and Ganymede for data capture and analysis. Apply a range of molecular, cellular, biophysical, and biochemical protocols. Collaborate with other departments to test LVV samples and support Umoja’s pipeline. Position Requirements Experience with molecular, cellular, biophysical, and biochemical assay protocols. Ability to work on-site in Louisville, CO, five days per week. Strong skills in assay execution, data analysis, and method development. Comfort with automation tools and data management platforms such as AI and Ganymede. Collaborative approach to cross-functional teamwork. Location Louisville, Colorado, United States (on-site, full-time)

Join Umoja Biopharma, a pioneering biotech company with a mission to revolutionize cancer treatment through our innovative integrated immunotherapy platform. With state-of-the-art facilities in Seattle, WA, and Louisville, CO, we are dedicated to developing off-the-shelf therapies that can address any tumor at any time. Our diverse and expanding team is passionate about pushing the boundaries of science and technology in the field of drug development. We invite innovative thinkers who are eager to face the challenges of cutting-edge healthcare solutions to apply and help us create impactful stories for patients and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYWe are looking for a highly motivated and detail-oriented Laboratory Materials Associate to support our Research and Development (R&D) and Quality Control (QC) laboratories at our Colorado Laboratory, Innovation and Manufacturing Building (CLIMB) facility. The ideal candidate will have a solid understanding of biology and cell culture lab operations. Responsibilities include restocking supplies, managing shipping and receiving, conducting inventory counts, and processing incoming inventory. This role also offers opportunities for involvement in continuous improvement projects and supporting additional supply chain functions as needed.This position requires on-site availability 5 days a week at our Louisville, CO location.

Umoja Biopharma develops integrated immunotherapy platforms aimed at advancing new cancer treatments. The Louisville, Colorado site supports a growing team focused on drug development, working alongside colleagues in Seattle, WA. Umoja emphasizes diversity, collaboration, and scientific progress in its approach. Role overview The Senior Manager, Quality Assurance Operations leads GMP operations at The CLIMB, Umoja’s lentiviral vector development and manufacturing facility in Louisville. This leadership role manages the QA Operations team and is responsible for ensuring compliance across all GxP areas, including Manufacturing, Supply Chain, Facilities, and Engineering. The position plays a key part in upholding quality standards and supporting best practices throughout the site. Location and schedule Onsite role in Louisville, Colorado Full-time, five days per week May require work on weekends or holidays as needed

Join Umoja Biopharma as a Quality Control Analytical Specialist, where you will play a crucial role in ensuring the quality and safety of our biopharmaceutical products. Your expertise will be essential in performing analytical testing, maintaining laboratory equipment, and ensuring compliance with regulatory standards. This is an exciting opportunity to contribute to innovative therapies that improve patient outcomes.

At Umoja Biopharma, we're at the forefront of biotechnology innovation, with facilities in Seattle, WA and Louisville, CO. Our mission is to revolutionize cancer treatment through a pioneering integrated immunotherapy platform. We envision the creation of off-the-shelf therapies that can address any tumor, at any time. Our diverse and dynamic team operates in state-of-the-art facilities and seeks inventive minds who are passionate about the challenges and rewards of advanced drug development. We invite committed individuals to join us in our journey to enhance patient outcomes and create meaningful narratives that resonate with families and communities.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYWe are currently seeking a Senior Analyst in Quality Control Microbiology to oversee testing and monitoring activities essential for the Quality Control Microbiology laboratory and the manufacturing areas at our lentiviral vector production facility.This position reports to the Senior Manager of Quality Control Microbiology and is fully onsite in Louisville, CO.

Umoja Biopharma is a pioneering biotechnology company with locations in Seattle, WA, and Louisville, CO, dedicated to revolutionizing cancer treatment through our innovative immunotherapy platform. Our mission is to create off-the-shelf therapies that can address any tumor at any time. We pride ourselves on our diverse and expanding team, operating in state-of-the-art facilities in downtown Seattle and Louisville. We are in search of creative thinkers who are passionate about cutting-edge science and technology, and who embrace the challenges associated with advanced drug development. We invite applications from individuals who resonate with our core values and principles, helping us achieve our ambitious goals. At Umoja, we value stories and seek outstanding individuals to join us in crafting impactful narratives for ourselves, our patients, and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYUmoja is actively seeking a Senior Director of Drug Product Development to lead our Process Sciences team. This role will oversee both internal and external drug product manufacturing processes for lentiviral vectors, encompassing formulation development, fill-finish, and technology transfer activities for various early and late-stage programs. Furthermore, this position will spearhead the process-related aspects of a facility capital project aimed at enhancing our internal fill-finish manufacturing capabilities.The ideal candidate will possess a comprehensive understanding of formulation development and fill-finish methodologies for both early and late-stage products, along with exceptional communication and collaboration skills to work effectively with leaders across Umoja.This position is fully onsite at our Louisville, CO location and will involve some travel. The role's level will be determined based on the candidate's experience and qualifications.

Umoja Biopharma is a pioneering biotechnology firm with offices in Seattle, WA, and Louisville, CO, dedicated to revolutionizing cancer treatment through an innovative integrated immunotherapy platform. Our mission is to create off-the-shelf therapies capable of addressing any tumor at any time. We pride ourselves on our diverse and expanding team, working in state-of-the-art facilities in downtown Seattle and Louisville. We seek forward-thinking individuals who are passionate about groundbreaking science and technology, and are eager to tackle the challenges that come with cutting-edge drug development. At Umoja, we value the stories we create and invite applicants who are enthusiastic and aligned with our commitment to improving the lives of patients and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYThe Vice President of Analytical Development will spearhead technical, operational, and strategic leadership for Umoja’s analytical development division. This role entails oversight of the release, characterization, and lifecycle management of analytical methods that support both clinical and commercial cell and gene therapy products. Reporting directly to the Chief Technical Officer (CTO), the VP will develop and implement the company’s comprehensive analytical strategy in close collaboration with Quality, Manufacturing, Regulatory, and Research departments.This individual will serve as a pivotal leader at the intersection of Research and Discovery, GMP Manufacturing, Quality, and CMC Regulatory, taking charge of analytical method development, qualification, validation, transfer, and specification setting for GMP products. The ideal candidate will possess extensive regulatory expertise—especially in IND and BLA submissions—exemplary leadership skills, and a proven track record in scaling analytical organizations in fast-paced biotech settings.This position is based in Louisville, CO (preferred) or Seattle, WA.

Umoja Biopharma is a pioneering biotech company with locations in Seattle, WA, and Louisville, CO, dedicated to revolutionizing cancer treatment through an innovative integrated immunotherapy platform. Our mission is to develop accessible therapies that can address any tumor, at any time. We pride ourselves on our diverse and expanding team, operating from state-of-the-art facilities in downtown Seattle and Louisville. We are in search of creative minds who are passionate about transformative science and technology, and who are eager to tackle the challenges associated with advanced drug development. At Umoja, we value the impact of storytelling and invite enthusiastic individuals to join us in creating meaningful narratives for ourselves and, more importantly, for patients and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARYWe are currently seeking a dedicated and skilled Materials Handler to become a vital part of our Supply Chain team. In this role, you will collaborate with various departments, including Manufacturing, Quality, and Laboratory Materials groups, to meet the material requirements of the business effectively.The Materials Handler will primarily focus on the receipt, stocking, inventory management, and data entry of materials to support pre-clinical, toxicology, engineering, and GMP manufacturing operations. Adherence to Standard Operating Procedures (SOPs) is essential, and the Materials Handler must demonstrate the ability to follow all SOPs and work instructions accurately.The successful candidate will work closely with stakeholders to anticipate needs, resolve issues swiftly, and provide a consistently high-quality service experience. We seek someone who takes ownership of their responsibilities, communicates effectively, and collaborates well to ensure our partners receive timely and effective support.Additional responsibilities may include communication with Umoja teams and providing feedback on warehouse processes. The ideal candidate will possess strong communication skills, be highly organized, and detail-oriented.Previous experience in a GMP environment and proficiency in operating a forklift are highly preferred.This position supports supply chain activities and reports directly to the Warehouse Manager, working on-site five days a week in Louisville, CO.CORE ACCOUNTABILITIESSpecific responsibilities include:

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Umoja Biopharma stands as a pioneering force in the biotechnology landscape, operating from our advanced facilities in both Seattle, WA, and Louisville, CO. Our mission is to revolutionize cancer treatment through an innovative immunotherapy platform that seeks to offer off-the-shelf therapies capable of targeting any tumor at any time. We take pride in our diverse and dynamic workforce that thrives in a collaborative environment, and we are on the lookout for forward-thinking individuals who are passionate about groundbreaking science and dedicated to tackling the complexities of drug development. We invite enthusiastic candidates to join us in our mission to create impactful stories for patients and their families.Umoja Biopharma – Your Body. Your Hope. Your Cure.POSITION SUMMARY We are currently in search of a Quality Assurance Specialist to enhance our GMP operations at The CLIMB, our state-of-the-art lentiviral vector development and GMP manufacturing facility located in Louisville, CO. This role will entail providing quality oversight of incoming materials, manufacturing processes, and offering general QA support for GMP operations at The CLIMB.This position is fully onsite at our Louisville, CO location.CORE ACCOUNTABILITIESKey responsibilities include:Exemplifying and championing Umoja’s quality cultureEstablishing productive cross-functional collaborationsCollaborating with various departments (Manufacturing, Supply Chain, Quality Control, Facilities, Engineering) to ensure adherence to all relevant procedures and standards.Providing on-site QA support during routine GMP operations and material disposition.Reviewing and approving work instructions, Standard Operating Procedures (SOPs), and material specifications related to GMP operations as necessary.Overseeing the disposition of incoming GMP materials.Initiating Quality Holds as necessary.Providing oversight on new material introductions, including the review and approval of new GMP material onboarding requests.

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