KCAS Bioanalytical & Biomarker Services is seeking an individual interested in bioanalysis to work as a Scientific Director within its GLP bioanalytical laboratory in Shawnee, Kansas. KCAS is a contract research organization (CRO) providing bioanalytical & biomarker services to pharmaceutical clients in support of drug developments, preclinical and clinical studies.
KCAS offers a full, competitive benefits package including paid time off, health, dental, vision, 401k, and more. Please see the careers page of the KCAS website for a full list of benefits.
This job ad is meant to provide a brief overview of the nature and level of work being performed and does not imply that these are the only duties to be performed.
Position Summary:
Responsible for the management and oversight of assigned studies and programs within area of focus related to Cell and Gene Therapy within a GLP laboratory environment. Subject Matter Expert in the field of Cell and Gene Therapy. Serve as primary scientific contact for key clients and manages the on-site support of their programs, as well as the support of specialty studies. Responsible for meeting assigned goals and objectives.
Key Job Responsibilities:
Typical responsibilities of the Scientific Director, BioPharma Services may include, but are not limited to, the following:
Function as Subject Matter Expert for studies and programs within assigned group within Biopharma Services, related to molecular techniques, such as nucleic acid extraction, real-time qPCR, droplet digital PCR (ddPCR), Sanger Sequencing and Next Generation Sequencing (NGS).
Able to serve independently as a Principal Investigator and/or Study Director: experience with design, method development, validation, and sample analysis using molecular technique such as real-time qPCR, droplet digital PCR (ddPCR), Sanger sequencing and NGS sequencing.
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 and theories as it relates to the cell and gene therapy drug development process, and regulatory updates of GLP requirements, and Good Documentation Practices (GDP) as it applies to cell and gene therapy bioanalysis.
Participant in strategic planning for securing and retaining new clients through building strong relationships and the development of new services and technologies.
Responsible for all group activities related to providing support of on-site programs and studies, related to Cell and Gene Therapy.
Produce a high-quality work product acceptable to meet appropriate regulatory, client and company expectations. Assigned work will be required to be completed, on time and within budgeted resource allocations.
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,
Ensure assigned departmental staff adherence to pertinent regulatory requirements and to departmental policies, practices, and procedures (SOPs, safety procedures and biosafety protocols.
Define operating procedures and resources required to maintain departmental equipment in good working condition, leveraging in house training and external service contracts.
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, through company’s scheduling and operations planning processes
Direct activities of assigned group 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.
Prepare and deliver salary and performance reviews; review and approve salary appraisals initiated by direct reports.
Monitor and increase the technical performance and expertise of direct reports through mentoring, coaching and counseling.
Attend in-house and national scientific meetings and give presentations as appropriate.
Ensure effective communication within departmental groups, to provide overlap of diverse expertise. Implement techniques to improve productivity, increase efficiencies and maintain state-of-the-art practices.
Hire competent staff and build a strong scientific and operational team.
Perform other related duties as assigned.
Education & Experience:
Bachelors in a scientific related field required, with minimum 12 years’ experience in CRO, Pharma, or Biotech industry conducting scientific research. MS or Ph.D. preferred.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Excellent knowledge of designing and validating real-time qPCR and ddPCR assays to support preclinical and clinical development of cell and gene therapies.
Analyze and interpret data, prepare summary tables and review raw data.
Deep and thorough knowledge of state-of-the-art principles, theories, and regulatory updates as it related to techniques used in Cell and Gene Therapy.
Good knowledge of MS Word, Excel, technical writing.
Basic understanding of hiring and employment practices.
PNL Responsibility (Preferred)
Subject Matter Expert with current industry trends and expectations.
Competencies, Skills & Personal Attributes:
Demonstrated ability to conduct scientific research in a non-GLP (discovery) environment.
Communication, team building and management.
Perform all aspects of job in a way that supports company brand and company mission, vision and values.
KCAS is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment 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.
