- 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.
- Educational Qualification: Degree in relevant technical discipline - Either a Bachelor's degree plus 10 years of relevant experience, , a Master's degree plus 8 years of relevant experience or a PhD plus 4 years of relevant experience.
- Excellent technical experience with state-of the art upstream bioprocess technologies (incl. PAT) & manufacturing operations.
- Proven project management experience and capability to work effectively in a team environment.
- 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.
-
Upstream Process Technology Lead
Gefunden in: Talent CH C2 - vor 1 Tag
Biogen Luterbach, Schweiz GanztagsJob Description · About This Role · As a key leader in Upstream Process Technologies you join the Global Manufacturing Sciences Department at the Solothurn drug substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities. · You lead cross-fu ...
-
Launch Manager, NGP
Gefunden in: beBee S2 CH - vor 5 Tagen
Johnson & Johnson Zuchwil, Schweiz OTHERMedical Device Business Services, Inc. and Synthes GmbH , a member of the Johnson & Johnson Family of Companies, is recruiting for a Launch Manager, NGP, to be located in Zuchwil, Switzerland. · The Johnson & Johnson Medical Devices Companies have been working to make surgery ...
-
Label Designer
Gefunden in: beBee S2 CH - vor 19 Stunden
Synthes GmbH Zuchwil, Schweiz Ganztags· Caring for the world... one person at a time" inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo . · DePuy Synthes Companies of Johnson & Johnson is t ...
-
Head Product Management
Gefunden in: Talent CH C2 - vor 5 Tagen
Gerresheimer Solothurn, Schweiz GanztagsJob Description · Role · By being responsible for leading the drug delivery product portfolio, you play a crucial role in shaping the future of our own-IP product portfolio. Together with the digital solution team and the Gerresheimer primary packaging units, you will create cros ...
-
Senior Product and Process Development Specialist in the Application Group
Gefunden in: Talent CH C2 - vor 3 Tagen
Nestlé Wangen, Schweiz HybridPosition Summary · Products and brands that everyone knows. An international working world that inspires. A career that picks up speed. In a global corporation with popular brands. Is this perhaps the position of your life? Our teams worldwide are committed to brands such as Bui ...
-
Senior Product and Process Development Specialist in the Application Group
Gefunden in: beBee S2 CH - vor 1 Tag
Nestlé Suisse S.A. Wangen, Schweiz GanztagsSenior Product and Process Development Specialist in the Application Group (CTAG) · Senior Product and Process Development Specialist in the Application Group (CTAG) · Position Snapshot · Location: Nestlé Wangen bei Olten, Solothurn, Switzerland · Working Time: Full-time · Contr ...
-
Manager (m/w/d) Project Engineering – Medizintechnik
Gefunden in: Talent CH C2 - vor 2 Tagen
Stryker Selzach, Schweiz GanztagsWhy engineering at Stryker? · At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healt ...
-
project manager
Gefunden in: beBee S2 CH - vor 19 Stunden
Inomo Technologies AG CH- Oensingen, Schweiz GanztagsPROJECT MANAGER - HARDWARE/FIRMWARE · Back to listLocation : Oensingen/SwitzerlandPosition : Project Manager · At Inomo Technologies, we are looking for candidates that have a passion for embedded systems and modern ways of developing them in terms of security and safety. · If yo ...
-
Manufacturing Science and Technology
Gefunden in: Joblift DE C2 Premium Dynamic - vor 3 Tagen
CSL Behring Bern, Schweiz GanztagsCSL Behring ist ein weltweit führendes Biotech- Unternehmen, das sich seinem Versprechen verpflichtet hat, Leben zu retten. In Bern entwickeln und vertreiben wir mit über 1'800 Mitarbeitenden lebensrettende Therapien für Menschen mit schweren und seltenen Krankheiten weltweit. · ...
-
Lead Developer SAP Integration 80-100%
Gefunden in: Talent CH A C2 - vor 2 Tagen
NTT DATA Business Solutions AG Diessbach bei Büren, Schweiz· Empowering you – to ignite your passion for technology Als Teil der globalen NTT DATA Gruppe, einem der Top 5 IT-Dienstleister weltweit, stehen wir für unsere offene und nachhaltige Unternehmenskultur. Mehr als Mitarbeitende aus 64 Nationen in über 30 Ländern zeigen, dass Viel ...
-
Lead Operation
Gefunden in: Talent CH A C2 - vor 2 Tagen
BKW Energie AG Diessbach bei Büren, SchweizDie BKW bietet ihren Kundinnen und Kunden international Gesamtlösungen in den Bereichen Energie, Gebäude und Infrastruktur an. Wir beschäftigen rund 11'500 Mitarbeitende. Gemeinsam bauen wir Netze, produzieren Energie, planen und realisieren energieeffiziente Gebäude und gestalte ...
-
Sales Operations Manager
Gefunden in: beBee S2 CH - vor 5 Tagen
Breitling AG Grenchen, Schweiz GanztagsYour profile: · You have at least 4 years of experience in Sales Operations Management and extensive SAP know-how · Ideally, you have strong knowledge of the watch industry · You have experience in team management and problem-solving · You have strong knowledge in SalesForce and ...
-
Lead Developer SAP Integration 80-100%
Gefunden in: Talent CH A C2 - vor 3 Tagen
NTT DATA Business Solutions AG Diessbach bei Büren, Schweiz· Empowering you – to break new ground Als Teil der globalen NTT DATA Gruppe, einem der Top 5 IT-Dienstleister weltweit, stehen wir für unsere offene und nachhaltige Unternehmenskultur. Mehr als Mitarbeitende aus 64 Nationen in über 30 Ländern zeigen, dass Vielfältigkeit ein fes ...
-
Manager Manufacturing Operation
Gefunden in: Talent CH C2 - vor 4 Tagen
Thermo Fisher Scientific Lengnau, Schweiz Ganztags: Responsible for the daily operations of Upstream processes in manufacturing suites, including schedule, shift rotations · Lead and develop Manufacturing Team in order to run areas robustly and efficiently, ensuring appropriate succession planning · Participates in definin ...
-
Training Specialist
Gefunden in: Talent CH C2 - vor 2 Tagen
Flexsis Lengnau, SchweizEINFÜHRUNG: · For our client, the Thermo Fisher Scientific Inc., a world leader in serving science based in Lengnau, we are looking for a committed personality asTraining Specialist · This is a full-time and permanent position. The start date is as soon as possible or within the ...
-
Manufacturing Professional
Gefunden in: Talent CH C2 - vor 2 Tagen
FLEXSIS Lengnau, Schweiz GanztagsEINFÜHRUNG: · Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competencies within the Interiman Group, we offer customized solutions in personnel consulting.With 25 years of experien ...
-
Head of Digital IP, Strategic Innovation
Gefunden in: Joblift DE C2 Premium Dynamic - vor 3 Tagen
CSL Behring Bern, Schweiz GanztagsThe Head of Digital IP, Strategic Innovation and Organisational Effectiveness has significant responsibility and impact. It includes innovation and optimisation of the performance of the enterprise global IP team, as well as supporting the IP aspects of digital technologies acros ...
-
Advanced Purchasing Engineer
Gefunden in: Talent CH C2 - vor 2 Tagen
Tornos Moutier, SchweizIntroduction · The Tornos Group is a world leader in industrialization solutions. TORNOS has always been the pioneer in the development, manufacture and distribution of automatic Swiss-type lathes and multispindle machines. We are proud of our 130-year history and our 640 employ ...
-
Head of PV Engineering 100%
Gefunden in: JOIN CH S2 T2 - vor 1 Tag
Green Energy Venture AG Lyssach, Schweiz EmployeeGreen Energy Venture, part of oe energy, is a consulting and service company operating along the renewable energy value chain. We have been connecting technology and financial markets on three continents for over two decades. Our fields of expertise are Engineering, Transaction M ...
-
Senior Sales Manager 100%
Gefunden in: JOIN CH S2 T2 - vor 1 Tag
Green Energy Venture AG Lyssach, Schweiz EmployeeGreen Energy Venture, part of oe energy, is a consulting and service company operating along the renewable energy value chain. We have been connecting technology and financial markets on three continents for over two decades. Our fields of expertise are engineering, transaction m ...
Upstream Process Technology Lead - Luterbach, Schweiz - Biogen
Beschreibung
About This Role
As a key leader in Upstream Process Technologies you join the Global Manufacturing Sciences Department at the Solothurn drug substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities.
You 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 coordinate daily activities & provide scientific leadership for lab studies to advance process understanding, support investigations & drive process improvements. You author and review technical documents, lead engagements during regulatory audits & filings and communicate project & technical issues.
What You'll Do
Qualifications
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 are self-driven with the desire to make a positive impact to peers, processes & patients.
Required Skills
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.