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QC Analytical Technology Senior Scientist, Gene Therapy

REMOTE, FL 00000

Posted: 03/05/2024 Employment Type: Contract Job Category: Scientific Job Number: 601194 Is job remote?: Yes Country: United States

Job Description

Target PR Range: 57-67/hr
*Depending on experience

The QC Analytical Technology Senior Scientist, Gene Therapy is an established subject matter expert and independently develops and leads projects and investigation study plans to meet deliverables.

Taking project management responsibility for QCAT gene therapy deliverables of moderate to high complexity, the QC Analytical Technology Senior Scientist, Gene Therapy develops and coordinates experimental and documentation activities internally and with CMO partners to meet project and portfolio milestones.

1.        Maintain a safe working environment: 
Comply with requirements from Safety Program, including Health and Safety mandates, local site-specific regulations and requirements.
2.        Responsible for maintaining a safe working environment. 
3.        Active participation in safety investigations and improvements.

4.        Ensuring actions comply with:
• Code of Responsible Business Practice
• Global Quality Policy
• Site’s Quality Manual
• current Good Manufacturing Practice as applicable to this role
• Health, Safety & Environment Management System
5.        Stay current with cGMP training as required to maintain compliance with quality and regulatory commitments.
6.        Follow documentation and data integrity requirements associated with generation, review and reporting of cGMP activities.
7.        Provide independent verification and review and/or approval of data and reports generated to support the development, validation, and analytical lifecycle management of gene therapy methods.
8.        Provides expertise in investigation of laboratory and manufacturing deviations, atypical results and method performance issues as a subject matter expert and leads the execution of appropriate testing and interpretation of analytical results.
9.        Prepare, review and update standard operating procedures, test procedures, protocols and associated documentation in the performance of development, validation, and analytical lifecycle management studies and investigations.

Develop, author and/or review standard operating procedures required to for internal and external cGMP QC activities.

10.        Responsible for ensuring that all activities performed and led are undertaken in compliance with associated SOPs, procedures, test plans and protocols as appropriate.  
11.        Manages the development of project plans including estimated cost, time and resources for the identified work activities.  Responsible for the oversight and management of moderate to large, complex projects that may be require global project management.

Provide technical leadership and project management of moderate to large QCAT projects as required.

Responsible for ensuring that the times and costs associated with studies and activities being led and undertaken are accurately recorded and reported for both financial and resource management.

Reports on the status and costs associated with the projects and studies being led to Head of QCAT and project sponsors. 
12.        Manages projects, investigations, regulatory submissions and during audits and inspections as a technical and subject matter expert.  
13.        Responsible for the management of the analytical lifecycle of methods within the area of technical and subject matter expertise.
14.        Responsible for ensuring appropriate maintenance and calibration of laboratory equipment is maintained.

15.        Scouting and evaluation of new technologies within the field of expertise.

Lead the remediation of analytical challenges through method improvements, as well as development and implementation of new methods and innovative technologies.

Independently develop and execute appropriate testing and experimental plans,. 

Lead the development, qualification, validation and transfer of methods between R&D, QC and external laboratories as required.
16.        Lead and participate in cross functional assessment and evaluation of innovative technologies and methodologies.  

17.        Provide colleagues with project leadership, technical and scientific support, and training as required.

Provide supervision to support and technical colleagues engaged in specific projects as required.
18.        Proactively participate in the development and execution of individual personal and professional development plans to maintain and build knowledge and expertise.
19.        Identify and participate in training and development opportunities to build personal and professional skills.
20.        Support and maintain working in an equitable working environment emphasizing the Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
21.        Other duties and responsibilities as assigned 

BS/BA in Engineering, Physical, or Biological Science or other appropriate technical field. Relevant post-graduate qualification (Masters or Doctoral degree) is preferred or equivalent learning through extensive industry experience (10+ years).

A minimum of 3 years’ experience in cGMP Quality Control and at least 2 years’ experience in method development for assessment of gene therapy products
•    Extensive experience in method development and validation for testing of AAV or similar products for gene therapy suitable for cGMP application
•    Experience in cGMP testing, with experience in the QC testing of gene therapy products a plus
•    Proven written and verbal communication skills
•    Extensive experience in all aspects of analytical method lifecycle management
•    Strong, demonstrated problem solving skills and experience in practical application of concepts into cGMP environments
•    Proven technical and scientific knowledge and experience aligned with QC
•    Demonstrated experience in managing complex project deliverables
•    Experience in project management and matrix leadership a plus
•    Experience in training and/or coaching of more junior colleagues 

•    Effective and risk-based decision-making capacity
•    Depth of technical knowledge and experience relevant to the QCAT Functional team
•    Ability to operate independently and as part of a team
•    Pragmatic and innovative approach to problem solving
•    Flexibility to manage changing priorities

*CO/NYC candidates might not be considered
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