Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
Parenteral Large Drug Product Process Owner for the late stage clinical and commercial manufacturing process of designated drug products manufactured internally by Biogen and external partners. The role is to ensure Biogen’s manufacturing processes are well understood; highly capable of meeting the specified quality attributes; well controlled and manufactured in a compliant way.
* Technical transfer of processes, and process modifications, into the Biogen Parenteral Facility for commercial and clinical manufacturing campaigns. The position will require a significant commitment to field work to oversee engineering studies, operations training and GMP manufacturing operations.
* The execution of Process Validation Runs, which consist of the review, approval and execution of process validation activities.
* Coordination of Manufacturing Sciences and Manufacturing Operations resources for production support, and investigational activities.
* Developing strategic initiatives to study/implement new manufacturing methods and technologies, and actively participating in continuous improvement programs. Perform evaluations to assess equipment and process fit technical consistency
Lead investigational activities:
* Perform investigations on process or product quality irregularities. These investigations ensure that product impact assessments are made in light of prior development history and prevent process deviation recurrences through assuring proper corrective measures are implemented.
* Develop strategic initiatives, which study and implement new manufacturing methods and techniques. These initiatives are intended to ensure Biogen parenteral drug products are manufactured in a way that continuously improves product quality and cGMP compliance.
* Review of process trends, identification of anomalies and implementation of corrective actions. These actions maintain high success rates, maximize yields and maintain product consistency. Routine trending analysis of manufacturing and process performance to convey timely status assessments to Manufacturing Operations Management.
Perform regulatory activities:
* Prepare, review and/or approve regulatory filings, such as BLA CMC filings, as required with the appropriate regulatory group.
* Prepare, review and approve process change proposals in concert with worldwide regulatory requirements.
* In-depth understanding of the pharmaceutical/biotech industry, with a focus on biologic drug manufacturing experience and in-depth knowledge of GMPs. Detailed knowledge of parenteral drug product manufacturing, equipment and systems is strongly preferred.
* Extensive pharmaceutical industry experience, with at least 8 years (12 years for Sr. Engineer III) of working in cross functional teams in broad and complex environments within matrixed organizations.
* Strong oral and written communication skills, including presentation skills and ability to effectively work across complex environment, both vertically and horizontally.
* At least a Bachelor’s degree in a subject relevant to biopharmaceutical drug product manufacturing.
Apply to Biogen (Senior Engineer II/III, Manufacturing Sciences (Parenteral Filling))
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