Bioassay Operations Manager
- Job Title
- Bioassay Operations Manager
- Job ID
- Work Remote
- Other Location
LabConnect improves lives by partnering with pharma/biotech companies and clinical research organizations (CROs) to accelerate the development of new medicines around the world. An independent, global, one-stop-shop focused on delivering central laboratory services that are tailor-made, timely and flexible to meet the evolving study demands from traditional to increasingly complex trials.
At LabConnect, we are a growing and global team. In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities. We believe in a friendly and collaborative environment with open lines of communication.
As a key member of the Translational Biomarker Sciences Group, the Bioassay Operations Manager will work in partnership with the Bioassay Leads, development functions, CROs, academic collaborators, and consultants.
What will you do?
- Operational leadership of bioassay and bio sample management for clinical studies, including central lab, safety testing, biomarkers, regulated bioanalysis, diagnostics, and biorepository
- Collaborate with Bioassay Leads to develop and implement bioassay outsourcing strategies
- Responsible for the operational oversight of CRO partners. Partner with Quality Assurance to ensure the quality oversight of CRO partners
- Provide a point of contact with CROs to manage relationships through recurring project calls and touch points
- Interface with the project managers at CRO partners to obtain project updates and communicate information internally to project teams
- Work with Bioassay Leads, external CRO partners, collaborators, and consultants to develop bioassay timelines, budgets, and milestones
What will you bring to the table?
- BS, MS, or Ph.D. in a life science discipline
- 10-15 years in the CRO/biopharmaceutical industry with significant experience in outsourcing biomarker, PK and ADA bioanalytical assay development, validation, and sample analysis with a strong understanding of clinical trial conduct and inspections
- Experience working on all stages of large global Phase 3 studies. Experience with vaccine studies is a plus
- Must be able to work both independently and in a matrixed team environment
- Ability to multitask, working on several projects simultaneously with minimal supervision
- Ability to work well with a wide range of stakeholders to build strong partnerships and alliances inside and outside the organization
Working Conditions/Physical Demands, Travel, etc.
While performing the duties of this job, the employee is frequently required to sit, talk, and hear. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to thirty pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.
What we offer
Receive a competitive salary and benefits package as you grow your career at LabConnect. Join our team and discover how your work can impact the lives of people all over the world
It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.
Equal Employment Opportunity Posters: https://www.dol.gov/agencies/ofccp/posters. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email email@example.com or call (423) 722-3155.
For more information, visit www.labconnect.com