Director, Assay Development

4 Days Old

Overview

Sherlock Biosciences based out of Cambridge and Oxford, UK, is a wholly owned subsidiary of OraSure Technologies Inc. (OTI). OTI enables the democratization and decentralization of testing to personalize healthcare and impact global health. Our ability to positively affect change is powered by the innovative tools and diagnostics we deliver to the market. Our products include molecular sampling kits for the genome and microbiome, and rapid diagnostics for infectious disease.

Leads team(s) responsible for development of Molecular Diagnostics products and the technologies that enable them. Responsible for team organization and performance including prioritization, planning, supervising and communicating the work of a team of scientists and technicians.

What You Bring (summary of qualifications below):

  • Past experience in successful development of molecular diagnostics products released for sale in US and/or international markets
  • Demonstrable experience in developing in vitro diagnostic products in the area of infectious disease
  • Demonstrable skill in developing clinical sample preparation methods that achieve product design goals under design control
  • Demonstrable technical skill and experience in the design and optimization molecular (preferably isothermal) in vitro diagnostic assays
  • Familiarity with FDA Quality Systems regulations
  • Excellent written and oral communication skills
  • Willing to work at the bench to assist in teaching technical skills to subordinates
  • Ph.D. with 12+ years of industry experience, preferably leading in vitro diagnostic assay development teams
  • Previous experience leading technical teams responsible for the development of products or components of in vitro diagnostic assays including assays for infectious disease agents
  • Previous experience participating in cross-functional product development teams and investigations
  • Expertise in optimization of formulations and production processes, conduct of Design of Experiments (DOEs) and evaluation of product performance

Responsibilities

  • Manages multi-tiered functional organization responsible for development of molecular diagnostic assays and associated enabling technologies
  • Works with executive management to prioritize projects and assign resources, communicating resource gaps as necessary
  • Works with technical leaders within functional organization to outline development, optimization and design verification plans
  • Collaborates with outside groups/companies as needed
  • May participate in cross-functional product development core teams
  • Supervises the design, evaluation, and optimization of experiments to develop safe and effective products
  • Applies biochemical, molecular and biophysical techniques to develop measurable parameters to assure reproducibility and stability in product manufacturing
  • Designs experiments, evaluates data, communicates results to others and determines subsequent course of action consistent with project and company goals
  • Develops technical staff in the design of experiments and proper use of controls and laboratory notebook keeping
  • Provides expert technical advice on competitor products, new products, and current scientific concepts that may lead to new products; maintains ongoing surveillance of marketing, scientific, and patent literature
  • Prepares and presents papers at scientific meetings and/or publishes in scientific journals
  • Writes invention disclosures describing patentable inventions arising from work performed
  • Determines needs for clinical specimens for product development and participates in the planning of analytical studies
  • Ensures compliance with all pertinent safety and regulatory policies
  • Mentors and develops a culture of scientific excellence within the team

Culture and Benefits

OTI encourages applications from all qualified candidates who represent the full diversity of the communities in which we operate. We apply a rigorous, consistent, and equitable standard to the assessment of all candidates, regardless of race, color, national origin, sex (including pregnancy), sexual orientation, gender identity, disability status, age, religion, veteran status or any other protected characteristic. We are committed to creating a diverse and inclusive environment where all employees are welcomed and belong. Please note, we do not use AI in our hiring process.

  • Private Insurance – supplemental health and dental coverage
  • Life Insurance Benefits
  • Pension scheme
  • Paid time off
  • Maternity and Parental Leave Coverage
  • Employee Referral Program
  • Employee Assistance Program
  • Employee Service Recognition
  • Job-related Training Programs
  • Hybrid or remote work possibilities depending on the role

Location: Banbury, England, United Kingdom

Equal Opportunity

OTI aims to create and foster workplaces that reflect the global communities we serve. We provide reasonable accommodations for applicants with disabilities during the recruitment process. If you require disability-related accommodation, please contact us.

Seniority level

  • Not Applicable

Employment type

  • Full-time

Job function

  • Other
  • Industries: Software Development
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Location:
Oxford
Job Type:
FullTime
Category:
Management & Operations

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