Mfg Scientist I, Global Mfg Sciences

Process Validation/tech Transfer:

• Prepare and execute Technical transfer of processes into CMOs from TD to CMO or from CMO to CMO.
• Designs and executes Process Performance Qualification Runs, which consist of the preparation, review, approval and execution of PPQ activities and related documentation and overall PPQ strategy

Investigations/Process optimization:

• Access and implement manufacturing processes changes to existing commercial processes including CAPAS & performs and document risk assessments
• Designs/Execute & analyze technical studies and supports the Technical Product Leads
• 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.
• Author Continued Process Verification and Annual Product Review Reports as appropriate for commercial programs

Regulatory activities:

• Draft and review regulatory filings, as required with the appropriate regulatory group.
• Prepare, review process changes proposals in concert with worldwide regulatory requirements.
• Contribute to writing of regulatory documentation

Cooperation:

• Contributes as member of cross functional project teams and Asset sub teams, works closely with partners from Quality, Manufacturing, Technical. Development at internal and external sites.

• At least a Bachelor’s/Masters or equivalent advanced technical degree in pharmaceutical technology, pharmaceutical engineering or equivalent science study
• An understanding of the pharmaceutical industry, with a focus on manufacturing experience and knowledge of GMPs.
• Cultural acumen in international setting.
• Good oral and written communication skills, including presentation skills and ability to effectively work across complex environment, both vertically and horizontally
• Effective decision maker
• Pharmaceutical industry experience, with at least 2 - 4 years of working in cross functional teams ideally in product development of Small Molecule/ Antisense Oligonucleotide (ASO) injectable dosage forms, technology transfer or manufacturing science of drug product (injectables). Additional experience in Small Molecule oral dosage forms beneficial.
• Travel experience both domestically and internationally in a business context.

The Manufacturing Scientist provides leadership and technical expertise in regard to various manufacturing processes across modalities and supports the implementation and manufacturing of Biogen’s Small Molecule and Antisense Oligonucleotide (ASO) injectable dosage forms as well as partly Small Molecule oral dosage forms. The primary responsibilities include process support for clinical and/or commercial manufacturing process of designated products manufactured by Biogen’s external partners (CMOs), ensuring Biogen’s manufacturing processes are well understood; highly capable of meeting the specified quality attributes; the processes are well controlled and manufactured in a compliant way at external manufacturing partners.

The function will participate in cross functional team activities as required within the organization and at the CMOs.