Are you an experienced scientist looking for a new opportunity? Are you looking for a chance to join on of the leading CDx organizations in the world? If you are, look no further...
This role will lead the research and development activities that support contracted pharma projects which develop companion diagnostic IVDs. Specifically, this person will lead scientific associates who develop the assays for use in pharma clinical trials. This person will leverage past experiences in the role of Development Lead and provide leadership and mentorship on product development processes.
location: Danvers, Massachusetts
job type: Permanent
salary: $155,000 - 165,000 per year
work hours: 9 to 5
- Directly leads scientific associates
- Acts as the Development lead on programs. Responsible for adherence to the Development process and compliance to the Quality Management System.
- Leads scientific associates in Statement of Work generation and partner onboarding. Is responsible for the technical component of program costing for SOWs.
- Responsible for On Time Delivery of project milestones and efficient team member utilization
- Implements the organization strategy and connects the team's work to the organization's purpose.
- Actively participates in and provides leadership for the use of the tools.
- Builds an environment in which Associates want to do their best and recognizes the team for successes. Demonstrates accountability for the work product and strives for continuous improvement
- Assesses Associate performance and Leadership qualities and enables the implementation of associate career development plans
- Supports employee engagement activities within the team
- BSc in a Scientific discipline, MS or PhD preferred.
- Ideal candidate has 7 to 10 years industry experience gained within an IVD development environment with growing management responsibility. Additional pharmaceutical industry experience is a plus.
- Experience with tissue-based assay development is helpful
- Experience with FDA and/or EU CE-IVD quality requirements and the preparation of relevant documents for the submission to these agencies.
- Strong experience in IVD Product Development, preferably with technical expertise in IHC and/or ISH assays on automated staining platforms.
- Demonstrable experience of driving the successful development and release of products through regulatory submissions.
- Travel expectations within this role are low (5% to 10%)
skills: Assay Development, Assay Method, Assay Verification, Medical Leadership, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.