Bioanalytical Diagnostics Director

Position Summary:

The Bioanalytical Diagnostics Director applies expertise in bioanalytical assays to support the design, development, and validation of assays used in clinical or commercial settings for activities related to in vitro diagnostics (IVD) and companion diagnostic (CDx) development, including writing and reviewing study documents. The position requires extensive technical background and clinical/regulatory experience running clinical assay development and validation in highly regulated environment, a natural aptitude for keeping track of multiple critical priorities and strong planning ability. Excellent communication skills are required for client discussions and presentations to regulatory agencies such as the FDA.

 

 

Essential functions of the job include but are not limited to:

• With oversight from management and regulatory team, provides scientific guidance to laboratory staff on assay development and validation, troubleshooting, analyzing, and reporting data
• Prepares development plans, validation protocols, and reports and reconciles input from colleagues and clients
• Provides technical updates to internal and external stakeholders on bioanalytical diagnostic assay programs (e.g.: CDx for immunogenicity assays)
• Collaborates with the regulatory team to provide information for regulatory filings
• Assists with preparation of proposals for diagnostic programs, helping to ensure that proposals are scientifically sound, meet client needs, and are accurately priced
• Partners with laboratory and operations teams to ensure resources are optimally utilized
• Assist internal and external clients and collaborators in the design and implementation of studies supporting the product development process through all phases of design control
• Coordinate cross-functional internal teams by driving business timelines and all key performance indicator deliverables
• Resolve and assist in resolution of operational/quality issues

 

Qualifications:

 

Minimum Required:

• D. preferred in Immunology, Cellular Biology or related field with at least 8-10 years of industry experience working directly in biologics, such as large molecule bioanalytical, vaccine development or CRO management
• Also acceptable, MS with > 15 years industry experience working directly in biologics, such as large molecule bioanalytical, vaccine development or CRO management

 

Other Required:

• A solid understanding of current GLP standards and a willingness to learn other standards including, but not limited to, CLIA, CLSI and assay requirements for PMA filings
• Excellent communication, interpersonal and multi-tasking skills required
• Must have demonstrated expertise in bioanalytical techniques including ELISA, MSD, and cell-based assays and hands-on working experience in Immunogenicity assay development
• Excellent communication, interpersonal, organizational, and multi-tasking skills
• Must be able to read, write, speak fluently, and comprehend the English language
• Proven experience managing and/or overseeing management of multiple projects simultaneously is a requirement
• Confidentiality, excellent use of judgment and discretion required relative to sensitive and restricted Company and employee information

 

Competencies:

• Business Acumen: Understands basic business operations and helps ensure that statements of work are followed
• Teamwork: Works collaboratively with colleagues and team members to achieve objectives
• Project Management: Demonstrated strategic planning and execution skills, managing multiple projects from the conceptual stage through completion
• Integrity and Ethical Behavior: Consistently treat sensitive information with appropriate discretion and can be trusted with confidential and restricted company and employee information

 

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and ci