Senior Scientist, Analytical Validation Project Management (Hybrid)
Analytical Research and Development at our company's Research Laboratories is seeking a scientist with extensive experience in validation of large molecule release and stability methods, to join our Large Molecule Analytical Validation team. The primary responsibility is to manage validation and transfer of analytical test methods in the biologics and vaccines portfolio within our company's global network. You will work closely with groups in our Research & Development Division Biologics and Vaccines Analytical Research and Development, Global Quality and Regulatory Affairs-CMC to ensure that methods are validated to current regulatory standards and in place at their testing site, to support commercialization of our company's large molecule products. You will also be expected to support authoring of relevant sections of global regulatory filings.
Apply project management tools to support validation and transfer activities for pipeline commercialization and inline supply projects.
Manage and serve as primary point of contact for internal/external labs in analytical method validation and transfer activities
Maintain timelines; manage review and approval of validation and transfer protocols and reports; assist labs with sample/consumable logistics in support of validation and transfer
Communicate effectively across functions and departments to assist management and governance teams in risk escalation, issue management and mitigation plan development.
Support subject matter experts and regulatory colleagues in authoring of relevant regulatory submission analytical sections.
Minimum education required:
Education & experience: Bachelor's degree in Bio - Engineering, bio –related science or related-field with a minimum of 3 years of relevant experience or Master's degree with a minimum of 2 years of relevant experience in analytical development or quality control
Required experience and skills:
Project management experience tracking, supporting and communicating timely delivery of milestones.
Ability to work independently and within cross-functional teams, in-person and remotely.
Strong knowledge and experience in application of current Good Manufacturing Practices to analytical activities within a quality management system
Experience using project management, validation and EDMS solutions (e.g. scheduling tools, PowerBI, Kneat, Trackwise)
Knowledge in current major market regulatory frameworks and prior experience in preparing regulatory submissions in common technical document format.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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Flexible Work Arrangements:Hybrid
Shift:1st - Day
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