Sr. Manager, Upstream Process Technology, MSAT

Vor 2 Tagen

Luterbach, Schweiz Biogen Vollzeit
Job Description

About This Role 

As Sr. Manager, Upstream Process Technology you will join the Global Manufacturing Sciences Department at the Solothurn drug substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities. You will lead cross-functional teams to facilitate new product introduction, process transfers, validation and advance process technologies. You will oversee technical support for manufacturing campaigns and provide leadership in addressing process deviations & change controls. 


As part of a talented team of Process Engineers & Scientists, you will coordinate daily activities & provide scientific leadership for lab studies to advance process understanding, support investigations & drive process improvements. You will author and review technical documents, lead engagements during regulatory audits & filings and communicate project & technical issues. 

What You'll Do 

  • Key technical leader in USP process technologies, accountable for coordination of technical and laboratory activities in support of technology transfer, continued cGMP manufacturing & process improvements. 
  • Provide guidance and coordinates USP Process Transfer & Sciences SME activities incl. GMS lab operations & studies. Establish efficient workflows. 
  • Lead cross-functional project teams to enable process transfer, validation & process life cycle activities. 
  • Accountable for technical manufacturing support through process monitoring, resolution of technical issues & participation in operations governance huddles. 
  • Lead technical process investigations, root-cause analysis and definition of appropriate corrective measures & effectiveness checks. Author and assess change controls. 
  • Author technical protocols/reports for process performance qualification, continued process verification, investigations, and regulatory submissions. 
  • Trend & analyze process data to guide & implement advancements of USP process technologies, process robustness & productivity initiatives. 
  • Communicate project/campaign/technical status to stakeholders and leadership while assuring alignment with strategic goals and site priorities.

Who You Are 

You are a highly experienced technical expert in upstream drug substance manufacturing operations and process sciences. You excel in coordinating technical expertise and leading cross-functional project teams to align with strategic goals and site priorities. You think broadly, considering the bigger picture while navigating complex challenges, and you drive results by ensuring that every action contributes to achieving measurable outcomes. You are self-driven with the desire to make a positive impact on peers, processes, and patients.


Qualifications

 Required Skills 

  • Bachelor's degree in a relevant technical discipline with a minimum of 10 years of relevant experience.
  • Master's degree in a relevant technical discipline with a minimum of 8 years of relevant experience.
  • PhD in a relevant technical discipline with a minimum of 4 years of relevant experience in MSAT.
  • Extensive experience in manufacturing operations within pharmaceutical or biotech facilities, with a strong background in cell culture technology.
  • In-depth technical expertise in advanced upstream bioprocess technologies, including Process Analytical Technology (PAT) and manufacturing operations.
  • Demonstrated project management experience with a proven ability to lead and collaborate effectively within a team environment.
  • People management experience.
  • Good interpersonal skills, with the ability to influence behaviors, negotiate, and resolve challenges with poise, tact, and diplomacy. 
  • Strong data analysis, technical writing, presentation and communication skills. 
  • Practical knowledge and application of cGMP and FDA/EMA compliance regulations and inspections, with experience interfacing with inspectors and/or agency personnel.


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. Read on to learn more about our DE&I efforts.

  • Sr. Manager, Upstream Process Technology

    vor 1 Tag

    Luterbach, Schweiz Biogen Vollzeit

    About This Role   As Sr. Manager, Upstream Process Technology you will join the Global Manufacturing Sciences Department at the Solothurn drug substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities. You will lead cross-functional teams to facilitate new product introduction, process transfers, validation and...

  • Manufacturing Upstream Associate III

    vor 1 Tag

    Luterbach, Schweiz Biogen Vollzeit

    Job Description As a Manufacturing Upstream Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance with cGMP standards....

  • Manufacturing Upstream Associate III, Luterbach

    vor 1 Tag

    Luterbach, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Manufacturing Upstream Associate III, LuterbachClient:BiogenLocation:Job Category:ManufacturingJob Reference:5c0ac7491a67Job Views:8Posted:21.01.2025Expiry Date:07.03.2025Job Description:Job DescriptionAs a Manufacturing Upstream Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial...

  • Process Execution Expert

    Vor 4 Tagen

    Luterbach, Solothurn, Schweiz Randstad Vollzeit

    Manufacturing Operations Role:This position is responsible for executing manufacturing processing steps and/or manufacturing support activities in a cGMP environment. The successful candidate will have a solid understanding of Biotech processes and be able to follow and comply with written procedures and protocols. They will also have strong documentation...

  • Manufacturing Associate Iii

    vor 23 Stunden

    Luterbach, Schweiz Biogen Vollzeit

    As a Manufacturing Upstream Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance with cGMP standards. If you thrive in a...

  • Manufacturing Coordinator V

    Vor 5 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    The coordinator V is responsible for supporting / enabling manufacturing activities in regard to Compliance, Documentation, Recipe driven operations, Changeover, Tech transfer, and or Training for day-to-day activity. In addition, the Coordinator V is in charge to represent Manufacturing by participating in intra, cross site alignments and cross functional...

  • Manufacturing Associate III, Luterbach

    vor 1 Tag

    Luterbach, Schweiz TN Switzerland Vollzeit

    As a Manufacturing Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream or downstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance with cGMP standards. If you thrive in...

  • Manufacturing Associate III

    Vor 4 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    Job DescriptionAs a Manufacturing Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream or downstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance with cGMP standards. If...

  • Manufacturing Associate III

    vor 1 Tag

    Luterbach, Schweiz Biogen Vollzeit

    Job Description As a Manufacturing Associate III, you'll be at the heart of our cutting-edge operations, playing a crucial role in the daily upstream or downstream manufacturing activities within a cGMP environment. Your responsibilities include operating process equipment, executing validation protocols, and ensuring strict compliance with cGMP...

  • Sr. Material Handler Ii

    Vor 3 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    **Job Description** About This Role** Manages and ensures a timely and accurate execution of all GMP warehouse activities. Receives goods and enter them into Oracle (OPM), supports preparation of goods for manufacturing (order picking) and ships finished goods, raw materials, and samples out from the site. Responsible for generic and non GMP receipts and...

  • QA Technical Authority, Quality Technical Services

    Vor 2 Tagen

    Luterbach, Schweiz Biogen Vollzeit

    **Job Description** About This Role** This position is providing Quality Assurance input and drives activities and projects in compliance with cGMP, regulatory requirements, Quality Management System and change control system. The main responsibility is accomplished by relevant knowledge in Bulk Drug Substance manufacturing processes and the QMS to...

  • Manufacturing Operations Specialist

    Vor 2 Tagen

    Luterbach, Solothurn, Schweiz Randstad Vollzeit

    Job Description    Randstad is looking for a skilled Manufacturing Associate II to perform daily manufacturing operations in a cGMP environment. Key responsibilities include operating process equipment, executing validation protocols, and revising cGMP documents to ensure compliance.    Responsibilities• Execute manufacturing processing steps...

  • Production Support Professional

    Vor 2 Tagen

    Luterbach, Solothurn, Schweiz Randstad Vollzeit

    Job Overview    We are seeking an experienced Manufacturing Associate II to join our team. In this role, you will be responsible for performing daily manufacturing operations in a cGMP environment. This includes operating process equipment, executing validation protocols, and revising cGMP documents to ensure compliance.    Key Responsibilities•...

  • Manufacturing Associate II

    Vor 4 Tagen

    Luterbach, Schweiz Randstad Vollzeit

    Jobdescription For our client, an international company in Solothurn, we are looking for a Manufacturing Associate II. General Information: Start date: 01.02.2025 End date: 31.01.2026 Extension: Possible Workplace: Solothurn Workload: 100% Remote/Home office: Not available Job Summary: Performs and documents daily manufacturing operations in a cGMP...

  • Manufacturing Site IT Head

    vor 1 Tag

    Luterbach, Schweiz TN Switzerland Vollzeit

    The Site IT Stakeholder Success Lead will facilitate alignment between IT and an assigned line of business. The Stakeholder Success Lead will be focused on ensuring that stakeholders are succeeding to achieve their goals with the IT system they are provided. To ensure “success” means working closely with stakeholders to understand their business strategy...

  • Manufacturing Site IT Head

    vor 1 Tag

    Luterbach, Schweiz Biogen Vollzeit

    About This Role The Site IT Stakeholder Success Lead will facilitate alignment between IT and an assigned line of business. The Stakeholder Success Lead will be focused on ensuring that stakeholders are succeeding to achieve their goals with the IT system they are provided. To ensure “success” means working closely with stakeholders to understand...

  • QA Sr. Associate Ii

    vor 23 Stunden

    Luterbach, Schweiz Biogen Vollzeit

    **Job Description** A** **About This Role** The Senior Associate II QA is being part of the Quality Compliance and Technical services team. This role is mainly responsible on Facility, Utilities and Equipment (FUE) Qualification and Validation at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/she is also...

  • Manufacturing Associate II

    vor 1 Woche

    Luterbach, Schweiz Randstad Vollzeit

    Jobdescription For our client, an international company in Solothurn, we are looking for a Manufacturing Associate II.General Information:Start date: 01.02.2025End date: 31.01.2026Extension: Possible Workplace: Solothurn Workload: 100% Remote/Home office: Not available Job Summary: Performs and documents daily manufacturing operations in a cGMP environment...

  • Manufacturing Associate II

    vor 1 Tag

    Luterbach, Schweiz Randstad Vollzeit

    JobdescriptionFor our client, an international company in Solothurn, we are looking for a Manufacturing Associate II. General Information: Start date: 01.02.2025 End date: 31.01.2026 Extension: PossibleWorkplace: SolothurnWorkload: 100%Remote/Home office: Not availableJob Summary:Performs and documents daily manufacturing operations in a cGMP environment...

  • Manufacturing Associate II

    Vor 7 Tagen

    Luterbach, Schweiz Randstad (Schweiz) AG Vollzeit

    For our client, an international company in Solothurn, we are looking for a Manufacturing Associate II.General Information:Start date: 01.02.2025End date: 31.01.2026Extension: PossibleWorkplace: SolothurnWorkload: 100%Remote/Home office: Not availableJob Summary:Performs and documents daily manufacturing operations in a cGMP environment including operation...