KEY FEATURE
Area is focused on various technical projects in support of the GMP laboratories, such as automation support, method projects activities (ex. method transfer and validation support activities method remediation and troubleshooting, method monitoring), critical reagents and reference standard programs, global technical oversight program, cell bank adventitious agent safety testing.
Job Summary:
- Primary duties of this position will include serving as a lead for various technical aspects of the QC areas.
- Position will provide both subject matter expertise as well as technical leadership on activities such as method related projects (ex. method transfers and validations), investigations, quality events, data analysis and trending, key program oversight (ex. reference standard program), and cross-functional interaction on various teams to enable appropriate overall QC support on projects and programs, as well as external coordination to contract organizations.
- Position will also assist in managing departmental and/or cross-functional teams occasionally.
Discretion/Latitude:
- Works autonomously and receives general instructions on new assignments.
- Proposes technical strategies and frequently discusses soundness of technical judgment and reviews progress in meeting objectives and timelines with supervisor.
- Operates under compliance requirements. May independently refer to or seek guidance on policies and practices.
Impact:
- Exerts some influence on the overall objectives and long-range goals of the organization.
- Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.
SKILLS/ QUALIFICATIONS
- Senior specialist who can focus on Non-laboratory activities
- Candidates need to have very good experience with monitoring activities
- Data analyses, data trending, statistical analyses, asset controls
- Looked at methods from statistical perspectives
- Experience writing SOP’s
- Experience working with reference standards.
- Method Validations-Monitoring
Must Haves:
- Statistics experience
- JMP (mini tab-managing excel spreadsheets) program experience-statistical package (this can be taught but is a huge plus)
- Analytical Method Experience is a MUST-3-5 years’ experience needed
- QC Experience necessary
- Must have a bachelor’s degree (PhD+ Masters also OK)
- GMP experience preferred
- Can be non-GMP but must be Pharma/Biotech Experience
Additional Information
- Not a lab based position
- Something that is outside the lab
- Working on analyzing
- Working on data trending activities, writing reports, analyzing data
All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP! I want to know more about your preferences.
If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!
