Provides oversight of the contract testing site(s).
Provides project management and technical/operational support.
Primary contact for assigned testing laboratories and assists in maintaining excellent supplier relationships and timely delivery of results to support batch release and creation of technical reports.
Provides oversight of CTO operations and strategies for ensuring timely delivery of contract testing results provided from a network of CTOs
* Provides technical support, review and approval of test methods, protocols and technical reports, includes travel to CTOs as necessary; interfaces with CTOs and internal departments to facilitate delivery of contract test results for release of drug product.
* Coordinates activities related to drug product and drug substance and /or antibody analytical method technology transfer and validation at contract testing sites.
* Monitors existing vendors' activities. This includes, but may not be limited to, reviewing vendor batch release data, trends, investigations and OOS test result reports.
* Evaluates external vendors/resources necessary to ensure the successful execution of testing drug linker and drug substance, participates in negotiations and facilitates the execution of legal documents required to engage CTO services
* Assists in the development and maintenance of budgets.
* Coordinates with stakeholders in the identification, development and implementation of policies, procedures and standards which impact the department, while working to ensure compliance with applicable regulatory requirements.
* Participates with Quality Assurance to provide technical support for contract site quality audits.
* Performs other tasks and assignments as needed and specified by management.
*BS in Life Sciences, Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
* Additional technical experience in an area allied with cGMP Quality, Phased approach to Quality Systems, Analytics to Support Biopharma Production Processes, 21CFR 210-211, ICH guidelines
* Strong understanding of pharmaceutical manufacturing processes for antibody drug conjugates, or biologics and/or small molecules
* Experience in manufacturing batch record review leading to lot release
* Experience with CTO management is necessary
* Excellent verbal and written communication skills, organizational and time management skills; strong attention to detail
* Strong project management skills
* Travel approximately 20% national and international
* Excellent knowledge of GMP, and ICH guidelines as related to product quality testing
* Experience in analytics for Biologics and sterile fill/finish
* Demonstrated experience with analytical method validation and related regulatory requirements.
* Demonstrated ability to develop project plans for analytical technology transfers, including the ability to manage one or more projects.
* Ability to influence without direct authority.
* Proficiency with Microsoft Office.
* Excellent verbal and written communication and skills.
* Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
* Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
* Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Sthree US is acting as an Employment Business in relation to this vacancy.