KCAS Bio
Director of BioPharma Services
KCAS Bio, Kansas City, Missouri, United States, 64101
Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what we get to do every day at KCAS Bio. If that gets you excited too, then maybe working at KCAS Bio is for you.When you work as a Director of BioPharma Services at KCAS, you get to further our mission as the core of KCAS, directing and leading our BioPharma team while carrying out and supervising all aspects of our studies.Our BioPharma LBA/ Biomarker Services lab team quantitates proteins and anti-drug antibodies to perform early drug discovery, preclinical toxicology work, and clinical studies, including multiplexing by LBA (ligand binding assays) platforms, LCMS (liquid chromatography mass spectrometry), and flow cytometry.Learn more about our work in BioPharma here:
Biomarker Services | KCAS Bioanalytical ServicesIn this role, we will rely on you for the following:
Expert knowledge and experience in designing, planning, and executing bioanalytical assays (ADA, PK, Biomarker and Nab), method development and validationExpert knowledge and experience in using common immunoassay platforms (ELISA, MSD, Luminex, etc.)Expert knowledge and experience in designing complex experiments & evaluating outcomes vs. regulatory guidelines, white papers, and current industry practicesResponsible for all departmental activities related to providing support of on-site programs and studies, for multiple departmentsAble to act independently as a project manager; develop, design, validate, interpret, prepare reports, and conduct assays and studies as assignedDevelop business leads to ensure the company’s financial successParticipate in business development opportunities; work toward expanding existing business and developing new opportunitiesResponsible for coordinating the feasibility and pricing of applying a wide variety of scientific principles and concepts to client projectsForecast and recommend strategies to accommodate growth when needed (space, equipment, human resource)Integrate activities with other business units (segments, departments, functions) within KCASProvide scientific and innovative thinking with an advanced level of technical skill and insight, keeping abreast and maintaining a broad knowledge of state-of-the art principles, theories, and regulatory updatesEnsure departmental staff adherence to pertinent regulatory requirements and to departmental policies, practices, and procedures (SOPs, safety procedures and biosafety protocols)Direct activities of assigned departments to ensure optimum performance of the group/function, to deliver high quality scientific data, on-time and within budget that meets or exceeds client expectationsDefine strategies and resources required to maintain departmental equipment in good working condition, leveraging in-house training and external service contractsPrepare and deliver salary and performance reviews; review and approve salary appraisals initiated by direct and indirect reportsAssure that continuous training and educational needs of the staff are met in a timely mannerAttend in-house and national scientific meetings and give presentations as appropriateEnsure effective communication within the entire business unit, to provide overlap of diverse expertise.Implement techniques to improve productivity, increase efficiencies and maintain state-of-the-art practicesPerform other related duties as assignedLeadership expectations:
Provide direct daily supervision and review the work of assigned departmental employees, to ensure scientific accuracy and adherence to departmental policies, practices, and procedures.Hire competent staff and build a strong scientific and operational teamSchedule and prioritize workload of direct reportsProvide advanced scientific and technical bioanalytical oversight and strategies to internal and external stakeholdersKey participant in strategic planning for securing and retaining new clients through building strong relationships and the development of new services and technologiesDevelop strong relationships with key accounts and represent KCAS to the customerCoordinate with Business Development, and KCAS executive management with respect to client/sponsor negotiationsDefine and optimize organizational structure to maximize production and capacity to meet future forecasted demand and allow for KCAS to be strategically positioned to capitalize on future growth opportunitiesEnsure departments produce a high-quality work product acceptable to executive management, on time and within budgetDevelop and maintain client/sponsor relationships, by being proactive, flexible, and responsive with timely and transparent communication and ensuring the organization is meeting or exceeding their needs, by delivering high quality standardsDevelop long and short-range operating objectives, organizational structure of direct reports and staffing requirements, including development of departmental plan for backup and succession planning of key technical personnelTo qualify specifically for this role, you will have:
Bachelor’s, Master’s, or PhD in Immunology, Biochemistry, Biotechnology, Biology, or related field with at least 10 - 20 years commensurate with experience from CRO or Biotech/Pharmaceutical in large molecule immunoassay development/validationMinimum 13 years’ experience in developing a wide variety of analytical and bioanalytical techniques for the quantitation of biotherapeutics, and immunogenicity.You must have hands-on and managerial experiences leading teams working on LBA and Cell-based assays (PK, ADA, BM and NAb)Excellent knowledge of the principles of bioanalysis for biotherapeutics, by current state of the art technologies and methodologies including but not limited to: LBA, Immunogenicity, ELISA, MSD, Luminex, SMCxPro, etc.Quantitation of Proteins, ADC’s, Oligonucleotides, Peptides and other biotherapeutic target analytes, through the utilization of diverse scientific procedures, calculations, and statistics.Working knowledge of state-of-the-art principles, theories, and regulatory updates for biopharmaceuticals, biomarkers, and biotherapeuticsExpert knowledge of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP)Ability to design, develop, validate, and execute ligand-binding assays including ELISA and ECL-based assayWatson LIMS proficiencies preferredStrong attention to detailCell-based assays experience is a plusGood written and verbal communication skillsStrong technical writing and basic computer skillsWillingness and ability to provide procedural training and coaching(Please note this is a representative summary of responsibilities, not a comprehensive or exclusive list of the duties to be performed in any position. Employees must follow instructions and perform additional duties as requested.)WHO YOU AREYou will thrive at KCAS Bio if you enjoy a relational environment, are purpose- and values-driven, embrace constant development and supportive leadership, and enjoy being part of innovative work.WHAT YOU’LL GETOur benefits include, and extend beyond, the traditional package. At KCAS Bio, you will enjoy company sponsored events like food trucks, family days and spirit days. You will grow in your career with KCAS University. You will be able to connect with like-minded employees to further KCAS Bio's approach to key areas such as wellness, inclusion, and community outreach. You will engage as an owner in our stock ownership program. You will have access to the latest technology. And you will be able to invest in the community with paid time off to volunteer.WHO WE AREWe are a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in both human and animal health fields. Demand for our expertise is growing and so is our need for great people to work in nimble, empowered teams committed to one another’s growth. At KCAS Bio, we advance both great science AND great people.KCAS Bio is proud to be an Equal Opportunity Employer. Among other things, we provide equal employment opportunities without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, sex, sexual orientation, gender identity, or any other legally protected category; we recruit qualified candidates without regard to citizenship status based on internal processes that enable us to hire the right candidates consistent with the appropriate U.S. Immigration framework; and we work with and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs, observances, and practices. Anyone who needs reasonable accommodation may send an email to
kcasrecruiting@kcasbio.com
or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.IND123
#J-18808-Ljbffr
Biomarker Services | KCAS Bioanalytical ServicesIn this role, we will rely on you for the following:
Expert knowledge and experience in designing, planning, and executing bioanalytical assays (ADA, PK, Biomarker and Nab), method development and validationExpert knowledge and experience in using common immunoassay platforms (ELISA, MSD, Luminex, etc.)Expert knowledge and experience in designing complex experiments & evaluating outcomes vs. regulatory guidelines, white papers, and current industry practicesResponsible for all departmental activities related to providing support of on-site programs and studies, for multiple departmentsAble to act independently as a project manager; develop, design, validate, interpret, prepare reports, and conduct assays and studies as assignedDevelop business leads to ensure the company’s financial successParticipate in business development opportunities; work toward expanding existing business and developing new opportunitiesResponsible for coordinating the feasibility and pricing of applying a wide variety of scientific principles and concepts to client projectsForecast and recommend strategies to accommodate growth when needed (space, equipment, human resource)Integrate activities with other business units (segments, departments, functions) within KCASProvide scientific and innovative thinking with an advanced level of technical skill and insight, keeping abreast and maintaining a broad knowledge of state-of-the art principles, theories, and regulatory updatesEnsure departmental staff adherence to pertinent regulatory requirements and to departmental policies, practices, and procedures (SOPs, safety procedures and biosafety protocols)Direct activities of assigned departments to ensure optimum performance of the group/function, to deliver high quality scientific data, on-time and within budget that meets or exceeds client expectationsDefine strategies and resources required to maintain departmental equipment in good working condition, leveraging in-house training and external service contractsPrepare and deliver salary and performance reviews; review and approve salary appraisals initiated by direct and indirect reportsAssure that continuous training and educational needs of the staff are met in a timely mannerAttend in-house and national scientific meetings and give presentations as appropriateEnsure effective communication within the entire business unit, to provide overlap of diverse expertise.Implement techniques to improve productivity, increase efficiencies and maintain state-of-the-art practicesPerform other related duties as assignedLeadership expectations:
Provide direct daily supervision and review the work of assigned departmental employees, to ensure scientific accuracy and adherence to departmental policies, practices, and procedures.Hire competent staff and build a strong scientific and operational teamSchedule and prioritize workload of direct reportsProvide advanced scientific and technical bioanalytical oversight and strategies to internal and external stakeholdersKey participant in strategic planning for securing and retaining new clients through building strong relationships and the development of new services and technologiesDevelop strong relationships with key accounts and represent KCAS to the customerCoordinate with Business Development, and KCAS executive management with respect to client/sponsor negotiationsDefine and optimize organizational structure to maximize production and capacity to meet future forecasted demand and allow for KCAS to be strategically positioned to capitalize on future growth opportunitiesEnsure departments produce a high-quality work product acceptable to executive management, on time and within budgetDevelop and maintain client/sponsor relationships, by being proactive, flexible, and responsive with timely and transparent communication and ensuring the organization is meeting or exceeding their needs, by delivering high quality standardsDevelop long and short-range operating objectives, organizational structure of direct reports and staffing requirements, including development of departmental plan for backup and succession planning of key technical personnelTo qualify specifically for this role, you will have:
Bachelor’s, Master’s, or PhD in Immunology, Biochemistry, Biotechnology, Biology, or related field with at least 10 - 20 years commensurate with experience from CRO or Biotech/Pharmaceutical in large molecule immunoassay development/validationMinimum 13 years’ experience in developing a wide variety of analytical and bioanalytical techniques for the quantitation of biotherapeutics, and immunogenicity.You must have hands-on and managerial experiences leading teams working on LBA and Cell-based assays (PK, ADA, BM and NAb)Excellent knowledge of the principles of bioanalysis for biotherapeutics, by current state of the art technologies and methodologies including but not limited to: LBA, Immunogenicity, ELISA, MSD, Luminex, SMCxPro, etc.Quantitation of Proteins, ADC’s, Oligonucleotides, Peptides and other biotherapeutic target analytes, through the utilization of diverse scientific procedures, calculations, and statistics.Working knowledge of state-of-the-art principles, theories, and regulatory updates for biopharmaceuticals, biomarkers, and biotherapeuticsExpert knowledge of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP)Ability to design, develop, validate, and execute ligand-binding assays including ELISA and ECL-based assayWatson LIMS proficiencies preferredStrong attention to detailCell-based assays experience is a plusGood written and verbal communication skillsStrong technical writing and basic computer skillsWillingness and ability to provide procedural training and coaching(Please note this is a representative summary of responsibilities, not a comprehensive or exclusive list of the duties to be performed in any position. Employees must follow instructions and perform additional duties as requested.)WHO YOU AREYou will thrive at KCAS Bio if you enjoy a relational environment, are purpose- and values-driven, embrace constant development and supportive leadership, and enjoy being part of innovative work.WHAT YOU’LL GETOur benefits include, and extend beyond, the traditional package. At KCAS Bio, you will enjoy company sponsored events like food trucks, family days and spirit days. You will grow in your career with KCAS University. You will be able to connect with like-minded employees to further KCAS Bio's approach to key areas such as wellness, inclusion, and community outreach. You will engage as an owner in our stock ownership program. You will have access to the latest technology. And you will be able to invest in the community with paid time off to volunteer.WHO WE AREWe are a fast-growing contract research organization (CRO) headquartered in Kansas City, pioneering the latest drug development in both human and animal health fields. Demand for our expertise is growing and so is our need for great people to work in nimble, empowered teams committed to one another’s growth. At KCAS Bio, we advance both great science AND great people.KCAS Bio is proud to be an Equal Opportunity Employer. Among other things, we provide equal employment opportunities without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, sex, sexual orientation, gender identity, or any other legally protected category; we recruit qualified candidates without regard to citizenship status based on internal processes that enable us to hire the right candidates consistent with the appropriate U.S. Immigration framework; and we work with and provide reasonable accommodations to individuals with disabilities and for sincerely held religious beliefs, observances, and practices. Anyone who needs reasonable accommodation may send an email to
kcasrecruiting@kcasbio.com
or call 913-248-3000 (for TTY assistance call 711) and ask for Human Resources.IND123
#J-18808-Ljbffr