- Participate in risk assessments that identify potential critical process parameters and key operating parameters for all the unit operations in the process, to prioritize process characterization studies and the development of a control strategy in the larger context of the Quality by Design (QbD).
- Provide expertise to technical teams in the implementation of strategies for characterization and process validation studies.
- Author validation master plans comprising but not limited to process design plans, process validation plans, continued process verification plans and associated protocols and reports.
- Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
- Ability to multitask and prioritize independently in a high paced environment.
- Knowledge and understanding of US and EU requirements for product lifecycle.
- Ensures existing practices comply with industry standards.
- Responsible for the alignment of the Aura's validation strategy and content with internal and external clients.
- Author risk assessments and validation documentation in close collaboration with internal and external interfaces as necessary.
- Provide validation support/expertise to CMC and MSAT.
- Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
- Contributes to the development of organizational objectives and principles.
- Exercises considerable latitude in determining objectives and approaches to critical assignments.
- Acts as primary contact in absence of management.
- Bachelors' and/or Masters' degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
- A minimum of eight (8) years of experience in the industry, ideally all clinical phases through commercial drug product.
- Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process validation.
- Experience with Design of Experiments (DoE) approach for process development and characterization.
- Prior experience with QbD initiatives and experience writing CMC documents and implementing QbD principles, tools, and processes is also required. Strong understanding of statistics and statistical tools including a track record of hands-on implementation of DoE as it related to QbD is strongly desired.
- Leadership skills to lead cross functional teams to ensure project success.
- Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
- Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
- Ability to travel approximately 15%.
- Aligned with Aura core values of collaboration, respect, innovation and teamwork.
- Experience within a multi-product facility and/or Contract Manufacturing Business is a plus.
- Validation experience using risk-based approach.
- Project management experience.
- Strong analytical ability.
- Experience with Process Validation; experience with protocol development and execution; experience with presenting documents during inspections (regulatory agencies).
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
- Ability to make independent sound decisions and independently manage priorities in alignment with departmental and corporate goals.
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Process Validation Manager, MSAT - Brighton, United States - Aura Biosciences
Description
Job Description
Job DescriptionSalary:About Aura:
At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care. We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.
We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology. AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved. Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases. Leveraging our VDCs' broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.
Position Summary:
Aura Biosciences is seeking a Process Validation Manager to contribute to the overall success of our novel therapy. This position will support the organization through the establishment of Aura's process validation program and ensure alignment with industry standards in accordance with the relevant product's lifecycle. The successful candidate will work closely with Process Development, MSAT, QC and QA functions in ensuring the success of the Process Performance Qualification (PPQ) campaign leading to commercial manufacture. The successful candidate must be able to troubleshoot complex validation issues and apply advanced validation engineering and scientific principles to the design and implementation of process or system modifications. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success. In this position you will also be responsible for guidance and technical review of protocols and reports related to process validation. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, complex projects.
Responsibilities include but are not limited to:
Minimum Requirements:
Success Factors:
