Head of Small Molecule and ASO Engineering
BiogenAbout the role
Job Description
About This Role
This key leadership role leads the Biogen Small Molecule and ASO Engineering Technical Authority function, which is accountable for engineering subject matter expertise in small molecule and antisense oligonucleotide (ASO) modalities. Technical Authorities possess a comprehensive understanding of the entire asset lifecycle, which encompasses performance, design, qualification, operation, maintenance, and reliability requirements. This Senior Director will report to the VP of Global Engineering and manage a team of subject matter experts that effectively contribute to all stages of the asset's lifespan: ensuring standards, specifications, and strategic approach to manage the optimal lifecycle of the asset.
What You’ll Do
Leverage industry-leading subject matter capabilities in small molecule and ASO engineering to create an aligned strategic technical direction for Biogen sites, external development and manufacturing operations, drive cost effectiveness, productivity and compliance. Primary accountabilities include:
- SME Internal to Biogen - Own strategic technical direction for all types of assets within the assigned subject matter area. Work across functions to provide technology support to facility, manufacturing projects and site operations by combining engineering principles, facilities knowledge, and design experience to lead the development of value-added technical designs, solutions, and best practices.
- SME External to Biogen - Pursue intentional, strategic collaborations with external stakeholders and peers in the industry. Develop relationships and liaise with Academia and Industry Key Opinion Leaders to provide vision to develop transformative approaches to Biogen manufacturing operations technology and solutioning. Utilize these industry forums to communicate Biogen successes and lesson learned in areas of technology excellence, including the publication of relevant technical papers. Keep account of our stats relative to industry and provide context for improvement opportunities.
- Innovation - Serve as a key innovation catalyst within Biogen. Working with internal and external stakeholders, this team will continuously acquire and maintain cutting edge knowledge of small molecule and ASO engineering concepts, standards, technologies, and applications for the life science industry.
- Capital Planning & Execution - Accountable for execution of small molecule and ASO engineering activities that support front-end planning and execution of capital projects. Lead technical ownership of small molecule and ASO site master planning, long range planning, tech maps, feasibility studies, and scope definition. Support technical assessment on any new or revised business development opportunities.
- Partnership with Site & External Manufacturing - Small Molecule Engineering Technical Authority engineers add value to site & external manufacturing via a partnership approach, including establishment and compliance oversight of technical standards as well as support needed to technical challenges and business development opportunities. This team provides interpretation, consultation, training, and technical decision-making as needed to support adoption and execution of these requirements at the site level.
- People Management – Oversee a team of experienced small molecule, ASO and industrial engineering professionals. Sustain a culture of innovation, setting and driving strategic priorities on the holistic technology landscape, to turbo-charge a continuously improving manufacturing operation.
Who You Are
You are an established leader in the process engineering space and have specialized knowledge in small molecule and ASO modalities. You believe in continuous engineering improvements and can quickly build credibility with business leaders. Your curiosity keeps you on top of the latest innovative trends, and you enjoy leveraging this knowledge to build business cases and advance engineering solutions. #LI-CC1
Qualifications
Required Skills
- BS in Chemical Engineering or related process engineering discipline
- A minimum of 15 years’ experience in Process Engineering in Biotech, Pharma or equivalent industry
- Expert knowledge of small molecule and ASO modalities including asset lifecycle management practices within those modalities; specifically, engineering / facility best practices, reliability engineering, engineering document management, computerized maintenance management, and commissioning / qualification / validation
- Expert knowledge and application of FDA and EMEA regulations.
- Advanced ability to influence individuals at both site and glo
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