Senior Small Molecules Drug Products/API Engineer II
Vor 2 Tagen
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.
-
Baar, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Senior Small Molecules Drug Products/API Engineer II, BaarClient:BiogenLocation:Job Category:-Job Reference:42e7e2195bb7Job Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:About This RoleThis individual contributor within the Small Molecule & ASO Engineering Technical Authority function is accountable...
-
Senior Manager Drug Product 80-100%
vor 21 Stunden
Baar, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Client:Location:Job Category:OtherJob Reference:e006f36d6f2fJob Views:6Posted:21.01.2025Expiry Date:07.03.2025Job Description:The Senior Manager DP Manufacturing will be the technical lead and primary contact responsible for managing commercial DP Contract Manufacturing Organizations (CMOs) and other third-party...
-
Regcmc Small Molecules Team Lead
Vor 3 Tagen
Baar, Schweiz Biogen Vollzeit**Job Description** About this role** **The role can be US based hybrid in Cambridge or RTP or Baar based in Switzerland** **What you'll do** - Accountable for line management and development of direct reports. - Managing RegCMC small molecule resources efficiently - budget tracking, ensure proper resources allocation (including external regulatory...
-
Senior Medical Product Development Engineer
vor 14 Stunden
Baar, Zug, Schweiz Randstad (Switzerland) Ltd. VollzeitJob Description:The role of a Project Engineer in Medical Products at Randstad (Switzerland) Ltd. involves preparing design options for product realization, developing working models and prototypes, and identifying performance, cost, quality, and timing trade-offs.Key Responsibilities:Developing and implementing design options for product...
-
Project Engineer Medical Products
Vor 2 Tagen
Baar, Schweiz Randstad VollzeitJobdescription Project Engineer in Medical Products Our client is an international, innovative company specializing in wound healing solutions and products. Location: Full-time (3/2 Home Office) Workload: 100% Your Role: Working as Project Engineer within the Supply Chain & Quality department your responsibilities will include: Prepare design options for...
-
Project Engineer Medical Products
vor 1 Tag
Baar, Schweiz Randstad Professionals VollzeitProject Engineer in Medical Products Our client is an international, innovative company specializing in wound healing solutions and products. Location: Full-time (3/2 Home Office) Workload: 100% Your Role: Working as Project Engineer within the Supply Chain & Quality department your responsibilities will include: - Prepare design options for product...
-
Product Development Engineer
vor 14 Stunden
Baar, Zug, Schweiz Randstad Professionals VollzeitAt Randstad Professionals, we are seeking a highly skilled Product Development Engineer to join our team. As a key member of the Supply Chain & Quality department, you will be responsible for developing innovative solutions for wound healing products.Your main responsibilities will include:Designing and developing product options for realization and creating...
-
Project Engineer Medical Products
Vor 2 Tagen
Baar, Schweiz Randstad VollzeitJobdescription Project Engineer in Medical Products Our client is an international, innovative company specializing in wound healing solutions and products.Location: Full-time (3/2 Home Office) Workload: 100% Your Role: Working as Project Engineer within the Supply Chain & Quality department your responsibilities will include: Prepare design options for...
-
Project Engineer Medical Products
vor 1 Tag
Baar, Schweiz Randstad (Switzerland) Ltd. Vollzeitjob details Project Engineer in Medical Products Our client is an international, innovative company specializing in wound healing solutions and products. Location: Full-time (3/2 Home Office) Workload: 100% Your Role: Working as Project Engineer within the Supply Chain & Quality department your responsibilities will include: - Prepare design options for...
-
Sr. Engineer III, Technology Transfer Leader
Vor 2 Tagen
Baar, Schweiz Biogen VollzeitAbout This Role The Sr. Engineer III will be leading, facilitating, or coordinating all activities pertaining to tech transfer within the Switzerland internal drug substance manufacturing site. Also, this person will lead technology transfer assignment and prioritization for drug product externally network. They will be responsible for creating,...
-
Baar, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Client:BiogenLocation:Job Category:OtherJob Reference:f054e3ee5358Job Views:14Posted:22.01.2025Expiry Date:08.03.2025Job Description:About This RoleThe Sr. Engineer III will be leading, facilitating, or coordinating all activities pertaining to tech transfer within the Switzerland internal drug substance...
-
Director, Regulatory Affairs, Cmc
Vor 7 Tagen
Baar, Schweiz Biogen Vollzeit**Job Description**: **About This Role** The Global Regulatory Reg CMC Lead is responsible for the line management of the team members reporting into him/her, with responsibilities for commercial activities for the designated small molecule products. The CMC GRL provides regulatory CMC leadership on cross functional sub teams (regulatory science project...
-
Manufacturing Operations Director
Vor 5 Tagen
Baar, Zug, Schweiz Biogen VollzeitAbout the RoleAs a key member of our global operations team, you will oversee technical and business operations at designated external manufacturing sites. This role involves driving strategic initiatives for business growth and operational excellence.You will be responsible for ensuring supplier performance meets quality, cost, and delivery specifications,...
-
E2e Product Supply Chain Planner
Vor 3 Tagen
Baar, Schweiz Biogen Vollzeit**Job Description**: **About this role**: The **E2E Supply Chain Planne**r is a member of the Commercial Supply Chain team and is responsible for the planning and coordination of commercial Finished GOOD (FG), Drug Substance (DS) & Drug Product (DP) The role develops supply and inventory plans based on dependent Finished Goods demand, inventory targets and...
-
Regulated Product Engineering Specialist
Vor 2 Tagen
Baar, Zug, Schweiz Randstad VollzeitCompany OverviewOur client is an international, innovative company specializing in wound healing solutions and products. They are seeking a skilled Project Engineer to join their team in the Supply Chain & Quality department. The successful candidate will have a strong background in mechanical design, materials, analysis, and manufacturing, with experience...
-
Senior Control Systems Engineer
Vor 2 Tagen
Baar, Schweiz emerson VollzeitJob Summary We are looking for a high-performing and experienced Senior Control System Engineer who will beresponsible for the engineering of project specific Process Control System solutions within the applications engineering field, to meet the requirements of both the end-users and Emerson Process Management business, mainly within the Life Science...
-
Product Development Manager
vor 14 Stunden
Baar, Zug, Schweiz Randstad (Switzerland) Ltd. VollzeitCompany Overview:Randstad (Switzerland) Ltd. is an innovative company specializing in wound healing solutions and products. We are seeking a highly skilled Project Engineer to join our Supply Chain & Quality department.Job Summary:The successful candidate will be responsible for project management and engineering activities within the medical products...
-
Senior System Engineer Cloud 80-100%
Vor 2 Tagen
Baar, Schweiz Redit VollzeitWir begleiten unsere Kunden auf dem Weg in die Digitalisierung. An verschiedenen Standorten in der Deutschschweiz sorgen unsere Mitarbeitenden mit viel Leidenschaft und Kompetenz dafür, dass sich die IT unserer Kunden vom Kostenfaktor zu einer flexiblen Innovationsplattform für moderne Zusammenarbeit entwickelt. Dein Herz schlägt für die IT und du...
-
Senior Control Systems Engineer, Baar
Vor 2 Tagen
Baar, Schweiz TN Switzerland VollzeitWe are looking for a high-performing and experienced Senior Control System Engineer who will be responsible for the engineering of project-specific Process Control System solutions within the applications engineering field, to meet the requirements of both the end-users and Emerson Process Management business, mainly within the Life Science Industry.As a...
-
Production Lead, External Manufacturing
vor 2 Wochen
Baar, Schweiz Biogen VollzeitJob Description** About This Role **In this role you will work under the coordination of a Virtual Plant Manager and manage manufacturing operations for specific product(s) at one or more CMOs. **What You’ll Do**: - Responsibilities include commercial and/or clinical supply. - Participate to one or several virtual plant teams. Manages a subset of...
