Senior Small Molecules Drug Products/API Engineer II

About This Role

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 in antisense oligonucleotide (ASO) modalities.

The ideal candidate will possess engineering experience and knowledge of process equipment and facility design in both small molecule API as well as small molecule OSD pharmaceutical production.

At Biogen, Subject Matter Expertise is demonstrated by possessing a comprehensive understanding of the complete asset lifecycle, which includes performance, design, install, CQV, operation, maintenance, and reliability requirements.

This role and team effectively contribute and add value to all stages of the asset's lifespan, ensuring standards, specifications, strategic approach to manage the lifecycle of the asset ensure optimal performance, efficiency, and longevity.

What You’ll Do

This SME has a strong API and OSD small molecule body of experience, a passion for innovation, and the ability to build strong partnerships at all levels across the enterprise.

SMEs will serve as thought leaders on technical projects, site committees, engineering teams, and industry forums. Objective of this function is to leverage industry-leading subject matter capabilities in small molecule to create an aligned strategic technical direction for Biogen PO&T site & external development and manufacturing operations;

drive cost effectiveness, productivity and compliance. Primary accountabilities include but not limited to :

SME Internal to Biogen - Own strategic technical direction for all types of assets within small molecule engineering. Work across functions and globally 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.

Support escalations from site investigations

SME External to Biogen - Pursue intentional, strategic collaborations with external stakeholders and peers in 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.

Lead / execute benchmarking exercises to inform 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, expectation will be that experts within this function continuously acquire and maintain cutting edge knowledge of concepts, standards, technologies, and applications for the life science industry and apply such to our global engineering systems where applicable.

Leading innovation involves constantly exploring and implementing new technologies and strategies to optimize factory performance, capacity, throughput, energy efficiency, sustainability, execution speed, and other measures to meet the evolving needs of Biogen.

• Capital Planning & Execution - Accountable for execution of activities in support to front-end planning and execution of capital projects.
• Lead technical inputs / activities for capital front end planning of potential project opportunities introducing new / advanced technologies;

lead technical ownership of long range planning, tech maps, feasibility studies, and scope definition. Provide technical leadership on capital projects introducing new / advanced engineering technologies as required and ensure capital projects align with small molecule technical standards and requirements via design reviews and site confirmations.

Support technical assessment on any new or revised business development opportunities. Ensure that reliability is integrated into the design, construction, and operation of new facilities, equipment, and systems.

Partnership with Site & External Manufacturing - Technical Authority engineers add value to site & external manufacturing in multiple ways, via a partnership approach, including establishment and compliance oversight of technical standards as well as support needed to technical challenges and business development opportunities.

Furthermore, this team provides interpretation, consultation, training, and technical decision-making as needed to support adoption and execution of these requirements at the site level.

Qualifications

Who You Are

You are an Engineer with a competent level of depth and breadth in command of the assigned subject matter expertise. You should have a solid understanding of manufacturing processes related to their assigned subject matter expertise and have demonstrated an ability to apply technical expertise to solve problems.

You have experience working on projects with increasing complexity, taking on more responsibility as appropriate, and would have demonstrated an ability to work collaboratively with cross-functional teams to deliver results.

You have demonstrated capability to lead engineering and CQV on projects / project opportunities that are generally considered to be complex.

• A minimum of 8 years’ experience in Process Engineering in Biotech, Pharma or equivalent industry
• Knowledge of small molecule API, small molecule OSD, and a plus is having ASO engineering experience including asset lifecycle management practices within the modality;

specifically, engineering / facility best practices, reliability engineering, engineering document management, computerized maintenance management, and commissioning / qualification / validation

• Experience with an A / E consulting firm is preferred but not essential.
• Expert knowledge and application of FDA and EMEA regulations.
• Excellent leadership, people management, organization, communication, and inter-personal skills are required
• Advanced ability to influence individuals at both site and global level
• Strong communication and presentation skills
• Understanding of asset lifecycle data analytic concepts and methods
• Already established network of technical leaders, peers, and stakeholders in life science industry; Actively participates in industry forums, etc.

Education

BS in Chemical Engineering or related process engineering discipline

MS or PhD in engineering discipline is strongly preferred but not required

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.

Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills.

Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply.

Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.

We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

to learn more about our DE&I efforts.