- Expert knowledge and experience in designing, planning, and executing bioanalytical assays (ADA, PK, Biomarker and Nab), method development and validation
- Expert knowledge and experience in using common immunoassay platforms (ELISA, MSD, Luminex, etc.)
- Expert knowledge and experience in Design complex experiments & evaluate outcome vs. regulatory guidelines, white papers, and current industry practices
- Responsible for all departmental activities related to providing support of on-site programs and studies, for multiple departments
- Able to act independently as a project manager; develop, design, validate, interpret, prepare reports, and conduct assays and studies as assigned
- Key participant in strategic planning for securing and retaining new clients through building strong relationships and the development of new services and technologies
- Develop business leads to ensure company's financial success
- Participate in business development opportunities; work toward expanding existing business and developing new opportunities
- Develop strong relationships with key accounts and represent KCAS to the customer
- Develop 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 standards
- Forecast and recommend strategies to accommodate growth when needed (space, equipment, human resource)
- Provide scientific and innovative thinking with advanced level of technical skill and insight, keeping abreast and maintaining a broad knowledge of state-of-the art principles, theories, and regulatory updates
- Ensure departmental staff adherence to pertinent regulatory requirements and to departmental policies, practices, and procedures [SOPs, safety procedures and biosafety protocols
- Provide direct daily supervision and review the work of assigned departmental employees, to ensure scientific accuracy and adherence to departmental policies, practices, and procedures. Schedule and prioritize workload of direct reports
- 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 expectations
- Define strategies and resources required to maintain departmental equipment in good working condition, leveraging in house training and external service contracts
- Assure that continuous training and educational needs of the staff are met in a timely manner
- Attend in-house and national scientific meetings and give presentations as appropriate
- Ensure 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 practices
- Perform other related duties as assigned
- Bachelor's degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with at least 20 years of experience from CRO or Biotech/Pharmaceutical in large molecule immunoassay development/validation OR
- Master's degree in Immunology, Biochemistry, Biotechnology, Biology, or related field with at least 15 years of experience from CRO or Biotech/Pharmaceutical in large molecule immunoassay development/validation OR
- PhD in Immunology, Biochemistry, Biotechnology, Biology, or related field and at least 10 years of experience from CRO or Biotech/Pharmaceutical in large molecule immunoassay development/validation
- Minimum 13 years' experience in developing a wide variety of analytical and bioanalytical techniques for the quantitation of biotherapeutics, and immunogenicity.
- 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 biotherapeutics
- Expert 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 assay
- Watson LIMS proficiencies preferred
- Strong attention to detail
- Cell based assays experience is a plus
- Good written and verbal communication skills
- Strong technical writing and basic computer skills
- Willingness and ability to provide procedural training and coaching
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Director of BioPharma Services - Olathe, United States - KCAS Bio
Description
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.KCAS Bio is seeking a Director of BioPharma Services within its GLP bioanalytical laboratory in Olathe, KS.
KCAS Bio is a contract research organization (CRO) providing bioanalytical & biomarker services to pharmaceutical clients in support of drug developments, preclinical and clinical studies.
As the Director of BioPharma Services at KCAS Bio, you will be part of the leadership and management of the Biopharma laboratory, including client deliverables and expectations.
You will also be part of the team responsible for developing workflow processes and systems to meet operational department goals and objectives as assigned.
Learn more about our work in BioPharma here: Large Molecule Bioanalysis - KCAS Bio and Biomarker services - KCAS Bio
In this role, we will rely on you to:
WHO YOU ARE
You 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 GET
Our 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 ARE
We 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 (3) 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 or call for TTY assistance call 711) and ask for Human Resources.
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