This individual contributor within the Small Molecule & ASO Engineering Technical Authority function is accountable for subject matter expertise in small molecule and, to a lesser extent, antisense oligonucleotide (ASO) modalities. The ideal candidate will possess engineering experience and knowledge of process equipment and facility design in both small molecule API and small molecule OSD pharmaceutical production. At Biogen, Subject Matter Expertise is demonstrated by a comprehensive understanding of the complete asset lifecycle, including performance, design, installation, CQV, operation, maintenance, and reliability requirements. This role and team contribute to all stages of the asset's lifespan, ensuring standards, specifications, and strategic management of the asset lifecycle for optimal performance, efficiency, and longevity.
What You’ll Do
This SME has extensive API and OSD small molecule experience, a passion for innovation, and the ability to build strong partnerships across the enterprise. SMEs serve as thought leaders on technical projects, site committees, engineering teams, and industry forums. The objective is to leverage industry-leading capabilities in small molecule to create aligned strategic technical directions for Biogen PO&T site & external development and manufacturing operations; driving cost-effectiveness, productivity, and compliance. Primary responsibilities include but are not limited to:
* SME Internal to Biogen - Own strategic technical direction for all small molecule assets. Collaborate across functions and globally to support facility, manufacturing projects, and site operations by applying engineering principles, facilities knowledge, and design experience to develop value-added technical designs, solutions, and best practices. Support escalations from site investigations.
* SME External to Biogen - Pursue strategic collaborations with external stakeholders and industry peers. Develop relationships with academia and industry key opinion leaders to foster innovative approaches to manufacturing technology. Use industry forums to share successes and lessons learned, and lead benchmarking exercises to identify improvement opportunities.
* Innovation - Act as a catalyst for innovation within Biogen. Stay at the forefront of concepts, standards, technologies, and applications relevant to the industry. Explore and implement new technologies and strategies to optimize factory performance, capacity, throughput, energy efficiency, and sustainability.
* Capital Planning & Execution - Lead activities supporting capital project planning and execution. Provide technical input for project scope, feasibility studies, and design reviews. Ensure new facilities, equipment, and systems incorporate reliability and meet standards.
* Partnership with Site & External Manufacturing - Add value through partnership, establishing and overseeing technical standards, supporting technical challenges, and facilitating business development. Provide interpretation, training, and decision-making support at the site level.
Qualifications
Who You Are
An engineer with deep expertise in the subject matter. You understand manufacturing processes related to your expertise and can apply technical knowledge to solve problems. You have experience managing complex projects, working collaboratively across functions, and leading engineering and CQV efforts. Requirements include:
* Minimum 8 years’ experience in Process Engineering within biotech, pharma, or similar industry
* Knowledge of small molecule API, OSD, and preferably ASO engineering, including asset lifecycle management, reliability engineering, documentation, CMMS, and CQV/validation
* Experience with A/E consulting firms is a plus
* Expertise in FDA and EMEA regulations
* Strong leadership, communication, and interpersonal skills
* Ability to influence at site and global levels
* Experience with asset data analytics
* Established network of industry peers and participation in industry forums
Education
BS in Chemical or related engineering discipline. MS or PhD preferred but not required.
Additional Information
Why Biogen?
We are a global team committed to excellence and innovation. As a mid-sized biotech, we offer stability and growth opportunities. Our talented team works together to deliver life-changing medicines. We value inclusion and diversity, believing it makes us stronger and more innovative. Join us to make a difference in patients' lives.
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