Scientific Project Manager
- Job Title
- Scientific Project Manager
- Job ID
- 27696173
- Location
- Remote,
- Other Location
- Description
-
Overview
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.
The Scientific Project Manager will be responsible for providing project management and subject matter expertise oversight of outsourced analytical testing, method development and validation of assays in the areas of flow cytometry, genomics/genetics and/or immunogenicity.
What will you do?- Coordinate outsourcing activities with analytical method performance oversight and timeline management of clinical studies involving large molecule bioanalytical assays in one or more of the following areas: flow cytometry, genomics/genetics and/or immunogenicity
- The initial point of contact between external vendors and internal stakeholders for outsourcing issue resolution, vendor capacity & capability management
- Provide technical support to troubleshoot specific issues that impact the project
- Ensure contracted studies are conducted in compliance with the respective protocol and applicable guidelines & regulations
- Implements transfer strategy and coordinates between the product team and technical experts
- Responsible for establishing production phase monitoring requirements (PT and trending)
- Technical monitoring of assay performance and evaluation of transfer pass/fail criteria
- Lead operational point of contact between vendor and client, ensuring vendor adherence to project plan
- Manage supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks and drive continuous improvement.
- Assist with writing SOPs for new laboratories and process improvement initiatives
- Assist with developing and implementing training documents and plans.
- B.S., Life Sciences or related field
- 3-5 years’ experience providing project management and subject matter expertise oversight of outsourced analytical testing, method development and validation of assays
- Strong technical understanding in one or more of the following areas: flow cytometry, genomics/genetics and immunogenicity
- Experience working with quality and regulatory requirements for HGRAC/China regulations
Working Conditions/Physical Demands, Travel, etc.
While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk or 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 25 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 talent@labconnect.com or call (423) 722-3155.
For more information, visit www.labconnect.com