Director of Biopharma Sciences

In 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 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 
• Develop business leads to ensure company’s financial success 
• Participate in business development opportunities; work toward expanding existing business and developing new opportunities 
• Responsible for coordinating the feasibility and pricing of applying a wide variety of scientific principles and concepts to client projects 
• Forecast and recommend strategies to accommodate growth when needed (space, equipment, human resource) 
• Integrate activities with other business units (segments, departments, functions) within KCAS 
• 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 
• 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 
• Prepare and deliver salary and performance reviews; review and approve salary appraisals initiated by direct and indirect reports 
• 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  

Leadership 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 team 
• Schedule and prioritize workload of direct reports 
• Provide advanced scientific and technical bioanalytical oversight and strategies to internal and external stakeholders 
• Provide direct daily supervision of departmental employees, to ensure scientific accuracy and adherence to departmental policies, practices, and procedures then schedule and prioritize workload of direct reports 
• Key participant in strategic planning for securing and retaining new clients through building strong relationships and the development of new services and technologies 
• Develop strong relationships with key accounts and represent KCAS to the customer 
• Coordinate with Business Development, and KCAS executive management with respect to client/sponsor negotiations 
• Define 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 opportunities 
• Ensure departments produce a high-quality work product acceptable to executive management, on time and within budget 
• 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 
• Develop 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 personnel 

To 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/validation 
• Minimum 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 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