246 Firmen für deine Suche.
  • drucken
  • Per E-Mail teilen

Bachem AG

Hauptstrasse 144
4416Bubendorf
  • drucken
  • Per E-Mail teilen

Bachem AG

Bachem is an independent, technology-based, public biochemicals company providing full service to the pharma and biotech industry. Bachem is specialized in the process development and the manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients (APIs), as well as innovative biochemicals for research purposes.

Bachem has more than 40 years of experience in peptide research Excellent know-how in peptide chemistry and organic synthesis (technology leadership) Efficient manufacturing processes (cost leadership) Bachem sets industry standards With headquarters in Bubendorf, Switzerland and affiliates in Europe and the US, Bachem works on a global scale and holds a leading position in the field of peptides.
Bachem is an independent, technology-based, public biochemicals company providing full service to the pharma and biotech industry. Bachem is specialized in the process development and the manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients (APIs), as well as innovative biochemicals for research purposes.

Bachem has more than 40 years of experience in peptide research Excellent know-how in peptide chemistry and organic synthesis (technology leadership) Efficient manufacturing processes (cost leadership) Bachem sets industry standards With headquarters in Bubendorf, Switzerland and affiliates in Europe and the US, Bachem works on a global scale and holds a leading position in the field of peptides.
Merken

01.10.2022

Bachem AG

Experienced Project Manager 100% (f,m,d)

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 01.10.2022

  • Festanstellung 100%

Festanstellung 100%

4416CH-4416 Bubendorf

Experienced Project Manager 100% (f,m,d) The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide. Bachem. Leading Partner in Tides In order to continue our organic growth, we are constantly looking for talent. We are looking for an experienced Project Manager, who fits well to our highly motivated and dynamic PM team. We are seeking for someone who complements our team capabilities and provides additional input. Your Tasks Project management of interdisciplinary teams (leadership, team building, goal achievement) Structuring and coordinating project specific activities including risk and time management Direct interaction with our global customers Operational activities e.g. generating and monitoring project plans, project documentation Close collaboration with our Business Development group to align with customer needs Participation in internal projects such as portfolio management Your Profile Master degree in a scientific field 5 years of relevant PM experience in a CMO and/or Pharma environment Well experienced in managing complex projects, ideally with PM certificate Solid knowledge in pharmaceutical value creation processes in the areas of R&D, production and/or quality assurance Team leader skills with attitude to promote collaborative team work and sustainable decision-making Excellent language skills in English; German is a plus Sound knowledge of MS Office incl. MS Project We offer an exciting and challenging job in a dynamic and growing environment, which guarantees diversity and personal advancement. If this information draws your attention and if you enjoy working and communicating across disciplines, we look forward to receiving your complete dossier. Interested Please submit your application with full supporting documents (motivation letter, CV, testimonials, diplomas) via Recruitment Tool to Fabienne Carabelli (HR Business Partner)
Inserat ansehen
Merken

01.10.2022

Bachem AG

Process Engineer

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 01.10.2022

  • Festanstellung 100%

Festanstellung 100%

4416CH-4416 Bubendorf

Process Engineer The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide. Bachem. Leading Partner in Tides In order to continue our organic growth, we are constantly looking for talent. Your Responsibilities A process engineer is responsible for supporting and maintaining critical and supporting equipment and instruments to ensure the manufacturing process is continuously in operation with minimal downtime. Concurrently, through process mapping, the process engineer is responsible to develop process improvement projects to create efficiency in the process. The process engineer will also be responsible for identifying and researching background for equipment purchases and making recommendation to management. Your Tasks Support the Director on capital projects for facility remodeling and expansion Perform activities associated with the design and qualification of the new and existing equipment used in a manufacturing plant Lead the process development, optimization and scale-up of lyophilization processes to cGMP and FDA-compliant Oversee implementation, commissioning, and qualification of clean room spaces and process equipment Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error Support strategic plans for process and plant improvements in order to increase efficiency and manage costs. Maintain a safety first approach to process development and manufacturing Communicate operational status regularly to senior management and to corporate management, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations. Maintain a high level of compliance and efficiency to drive the organization to world-class manufacturing standards Write design qualifications for qualifying batch processing tanks, reactors, filter dryers, HPLCs, filtration system, lyophilizers, cold rooms, ultra-low freezers, HVAC, compressed air, and purified water Create new process and equipment drawings to existing processes based on specifications and standards Update drawings and P&ID to reflect changes to existing processes Maintains drawing files (CAD, P&ID Diagram, PDF, and hard copies) Responsible for trouble shooting and providing corrective action directives Troubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacities Create, execute validation protocols and write validation summary reports Draft of new procedures, SOP’s and protocols as well as training of staff for these expectations Perform process development studies for new and existing projects Write summary reports to support the process development data Write standard operations procedures, standard test procedures, master batch records and other related GMP documents Your Profile BS degree in Mechanical, Electrical, Chemical, Manufacturing Engineering or a Science related field 3+ years of experience in engineering within a pharmaceutical manufacturing operation Specific knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles Understanding of engineering fundamentals Technical knowledge of processes/equipment/utilities (e.g. batches processing, tank, filtration, lyophilization, purified water system, HVAC, etc.) Equipment Qualification and Validation IQ/OQ/PQ, SOPs Excellent written and oral communication skills Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues Ability to work independently and manage one’s time Basic computer knowledge, including Microsoft Word and Excel (used daily) Communicate effectively and ability to function well in a team environment Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Detail oriented with the ability to troubleshoot and resolve equipment problems. Strong analytical math and problem solving skills Proficient in reading schematics and diagrams as well as other written materials High level of safety awareness Nearest Major Market: Los Angeles
Inserat ansehen
Merken

01.10.2022

Bachem AG

Facilities Technician

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 01.10.2022

  • Festanstellung 100%

Festanstellung 100%

4416CH-4416 Bubendorf

Facilities Technician The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide. Bachem. Leading Partner in Tides In order to continue our organic growth, we are constantly looking for talent. Your Responsibilities The Facilities Technician, in conjunction with the Facilities Maintenance Manager is responsible for assisting with the building maintenance and repairs. This position is an intermediate skilled position with skillset based on an electrical background. The Facilities Technician will work on all the electrical systems and be responsible for all electromechanical repairs. Your Tasks Maintaining electrical and electromechanical systems within the facility including but not limited to, breaker panels, generators, electrical motors and motor controls Attend to all assigned work and general services orders, including but not limited to: painting, plumbing, electrical, mechanical, construction and flooring Troubleshoot, evaluate and make recommendations during regular inspections Perform routine and non-routine equipment maintenance, modification and repairs in a timely basis Cross-train other Facility Technicians and build their current skillset Maintain effective preventative maintenance programs, as directed by Management Document repairs, adjustments and replacement of equipment per SOP’s and cGMP regulations Complete and coordinate with department heads all repairs, as necessary, to offset downtime and production delays Assist maintenance contractors if applicable in trouble shooting of equipment Order parts and components for repairs as needed Assist with the organization and inventory of spare parts Maintain a clean and well organized maintenance room Provide after hours on call support including holidays Must follow all safety rules and ensure compliance In conjunction with the safety committee, develops and implements the policies and procedures necessary to adhere to all government requirements Must arrive to work on time for both scheduled shifts and unscheduled call in shifts Your Profile High School diploma Minimum of 5 years’ experience as a maintenance technician or maintenance engineer Experience in electrical, plumbing, HVAC, carpentry, equipment and high mechanical ability Intermediate experience with electrical systems and controls Familiarity with VFD controllers, PLC logic controllers, chillers, boilers, electrical circuits, air handlers, air conditioners, and all general facility equipment Ability to troubleshoot malfunctions within various systems throughout the facility Possess and maintain a valid driver’s license and good driving record Familiarity with building code and electrical related laws and regulations Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one’s time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Must be able to work a rotating on-call schedule (for weekends) Preferred Familiarity of standard laboratory practices Environmental Health and Safety regulations We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity. Nearest Major Market: San Diego
Inserat ansehen
Merken

01.10.2022

Bachem AG

Research Scientist

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 01.10.2022

  • Festanstellung 100%

Festanstellung 100%

4416CH-4416 Bubendorf

Research Scientist The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide. Bachem. Leading Partner in Tides In order to continue our organic growth, we are constantly looking for talent. Your Responsibilities The Research and Development Scientist will conduct basic research associated with the synthesis of peptides. He/she will evaluate new reagents and processes applied to the synthesis of peptides and will also evaluate new approaches to the purification of peptides. He/she will assist the production department in identifying impurities generated during production of peptide APL. With his/her in-depth knowledge of peptide chemistry he/she will identify mechanism associated with the formation of these impurities, and conduct experiments to support their identity. He/she will utilize appropriate analytical techniques to confirm the identities of proposed impurities structure; and will have the responsibility for preparing reports describing the work executed, and the conclusion of the project assigned. Your Tasks Stay abreast of developing new technologies and production procedures Executed research projects in the field of peptide chemistry, including but not limited to SPPS, purification, and isolation of peptides Design and execute projects associated with the characterization of peptide impurities Produce analytical amounts of proposed chemical impurities Interact with internal and external analytical laboratory to interpret data associated with the characterization of chemical impurities Your Profile Ph.D. in Organic Chemistry or Biochemistry or Master’s Degree in Organic Chemistry or Biochemistry with at least 3 years’ experience High competence in new trends and emerging technologies in the field of peptide chemistry Strong analytical skills and ability to solve chemical problems Experience in different analytical HPLC technique, with extensive experience in RP-HPLC In depth understanding of MS spectroscopy applied to peptide analysis Understanding of general NMR principle {1H-NMR, 13C-NMR, 2D-NMR) and NMR data interpretation Experience in organic chemistry Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one’s time Communicate effectively and ability to function well in a team environment Nearest Major Market: Los Angeles
Inserat ansehen
Merken

01.10.2022

Bachem AG

Manager, Quality Control

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 01.10.2022

  • Festanstellung 100%

Festanstellung 100%

4416CH-4416 Bubendorf

Manager, Quality Control The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide. Bachem. Leading Partner in Tides In order to continue our organic growth, we are constantly looking for talent. Your Responsibilities The Manager, Quality Control fulfills a critical role in active pharmaceutical ingredient development and manufacturing operations. This individual manages quality control and analytical method development & validation activities for the in process control (IPC) to support production and process R&D within the QC department in compliance with cGMP. Your Tasks Maintain and coordinate the operation of the IPC group to meet client/company/regulatory goals. This includes assign, prioritizing, and monitoring work for the group members on a regular basis. Review laboratory notebooks, raw data, development/summary reports, methods, protocols and operational SOPs as necessary. Oversee the execution of analytical activities and ensure these activities meet the quality requirements and in compliance with relevant regulations Attend project/production meetings as a SME representing QC. Proactively plan analytical activities to ensure these activities will meet projects timelines. Actively communicate with internal and external customers to provide them solutions to meet project timelines with high quality. Author and/or review protocols, reports, and project updates. Write/review standard operating procedures, standard test procedures and other related cGMP documentation. Review data for completeness and accuracy. Maintain up-to-date scientific knowledge pertaining to the field of analytical chemistry (e.g. theories, practices, equipment and technology), as well as regulatory requirements Work with R&D, QA, RA, CMC and MFG to ensure our supports are meeting their needs. Maintain the instruments in the lab and ensure they are qualified and are operational. Schedule use of instruments and coordination of instruments with other groups Work with QA to help maintain GMP and ICH compliance Your Profile Ph.D. in Chemistry, Biochemistry or related field with a minimum of 5 years’ experience in peptide/small molecule analytical chemistry or Master’s Degree in Chemistry, Biochemistry or related field with a minimum of 7 years’ experience in peptide/small molecule analytical chemistry or Bachelor’s Degree in Chemistry, Biochemistry or related field with a minimum of 9 years’ experience in peptide/small molecule analytical chemistry Broad knowledge of modern analytical chemistry Hands-on experience with HPLC/UHPLC, IC, GC, LC-MS Experience with QC or method development Experience writing standard operating procedures (SOPs) and technical reports Prior supervisory and project management experience Creativity to solve technical and compliance problems Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint. Experience with Microsoft Project is a plus Ability to effectively organize, prioritize, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one’s time Communicate effectively and ability to function well in a team environment Experience with Microbial and Endotoxin Validation will be a plus Nearest Major Market: San Diego
Inserat ansehen
Merken

30.09.2022

Bachem AG

Director, Maintenance

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 30.09.2022

  • Festanstellung 100%Management / Kader

Festanstellung 100%

Management / Kader

4416CH-4416 Bubendorf

Director, Maintenance The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide. Bachem. Leading Partner in Tides In order to continue our organic growth, we are constantly looking for talent. Your Responsibilities The Director, Maintenance is responsible for the coordination and direction of Facility and Equipment Maintenance of the Bachem Americas, Inc. facilities in Vista, California. This position will manage the maintenance programs to ensure full compliance with GMP requirements. The Director will be responsible for development and updating programs including preventative maintenance, capital installation projects, energy conservation programs, Computerized Maintenance Management system, supervision of direct reports, and facility programs support. Your Tasks Ensure full compliance to policies and guidelines Proactively work to identify equipment replacement needs Develop and implement changes to the Preventive Maintenance (PM) and Predictive Maintenance (PdM) Programs to ensure full compliance Prepare budgets for the Maintenance Engineering department Maintain costs within the budgeted expenses within all areas of control Work with Quality, IT, Engineering and Production Departments to develop and maintain Alarm Logging systems and Trending requirements and provide guidance to ensure continuous monitoring and system improvements Ensure that Federal, State, and Local regulations, including GMP and EHS regulations, are complied with as evidenced by internal audits and inspections from Government Agencies Train, guide, and evaluate employees in the interpretation of company policies, goals, and objectives for the company sites Maintain an adequate workforce to support present needs and plan for departmental requirements in the future Promote good relationships within the department and with other departments within the company Coordinating with all departments in technical matters dealing with plant infrastructure, instruments and equipment Maintain and troubleshoot key equipment and ensure continuous and smooth operation Coordination of maintenance, engineering, and construction activities Cost control of plant related activities, contractors and utilities Direct recurring calibration/certification of equipment and instruments Advise executive management and department managers about improvements, acquisition of buildings and equipment Coordinate and manage building monitor systems, providing system alarms and status through Ethernet solutions Manage/administrate the Computerized Maintenance Management System Monitor all facility and production equipment and/or service as per compliance with in-house Standard Operating Procedures Manage Preventative Maintenance (PM) program; includes schedules, and non-routine repairs Maintain Equipment History files to track maintenance, equipment manuals, and supporting documentation Provide Engineering assessment, user functional requirements and estimates for equipment, utility or facility upgrades Participate as a key member of the management team Responsible for troubleshooting of equipment/facilities; requires 24 hour phone monitoring and possible weekend and after hours response Manage contract service providers; includes training, scheduling, coordination, external SOPs, and documentation of all work in accordance with GMP requirements Must have strong negotiation skills and significant experience in interacting with contractors Submit annual budget proposal to management while taking responsibility for department budget control Review/modify in-house Standard Operating Procedures Train department members in safety and job related functions Supervise regulatory and safety requirements related to departmental functions Your Profile Bachelor’s Degree in Science or Engineering Minimum of 10 years work experience Technical knowledge of facility equipment, analytical instrumentation, process equipment, and all associated applications Experience in facility and equipment maintenance, troubleshooting, and engineering Experience with equipment and instrument qualification and calibration Ability to Manage and lead a team Proficiency with Technical writing Working knowledge of cGMPs as they relate to a pharmaceutical manufacturing facility Detail oriented with the ability to troubleshoot and resolve equipment problems Proficient in reading schematics and diagrams as well as other written materials Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Ability to work independently and manage one’s time Communicate effectively and ability to function well in a team environment Preferred Experience with Peptides We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity Nearest Major Market: San Diego
Inserat ansehen
Merken

30.09.2022

Bachem AG

Director Engineering (m/w/d)

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 30.09.2022

  • Festanstellung 100%Management / Kader

Festanstellung 100%

Management / Kader

4416CH-4416 Bubendorf

Director Engineering (m/w/d) Die in der Schweiz gegründete Bachem Gruppe ist ein börsenkotiertes, innovatives Unternehmen, das sich auf die Entwicklung und Herstellung von PepTides und OligonucleoTides spezialisiert hat. Als Full-Service-Provider bietet Bachem Produkte für die klinische Entwicklung und kommerzielle Anwendungen sowie einen umfassenden Katalog und exklusive Auftragssynthesen an. Mit 50 Jahren Erfahrung und Niederlassungen in der Schweiz, den Vereinigten Staaten, Grossbritannien und Japan ist Bachem der Partner der Wahl für die Biotech- und Pharmaindustrie weltweit. Bachem. Leading Partner in Tides Um unser organisches Wachstum weiterführen zu können, sind wir kontinuierlich auf der Suche nach Fachkräften. Um auch zukünftig das kontinuierliche Wachstum der Bachem in Bubendorf und an unserem neuen Standort in der Nordwestschweiz mitgestallten zu können, suchen wir zur Erweiterung unseres Teams im Engineering eine Verstärkung in der Funktion als Director Engineering (m/w/d) . Der Stellenantritt ist per sofort oder nach Vereinbarung geplant. In dieser neu geschaffenen Führungsfunktion sind Sie für die Leitung eines Engineering Teams zuständig. Sie sichern durch Ihre vorausschauende und proaktive Art unser organisches Wachstum und die damit verbundene Konzeptionierung und Umsetzung von neuen Anlagen, Installationen und Gebäuden. Ihre Aufgaben Fachliche und personelle Führung von Projektleitern und Projektingenieuren (Führungsspanne von insgesamt ca. 5 - 10 Mitarbeitenden) Sie sind Verantwortlich für die Entwicklung Ihrer Abteilung und Ihrer Mitarbeitenden im Hinblick auf künftige Aufgaben und Herausforderungen und fördern und fordern gezielt Gemeinsam mit Ihrer Abteilung setzen Sie die Unternehmenswerte und –Ziele in konkrete Massnahmen um Neben Ihrer Tätigkeit als Führungsperson leiten Sie selbst kleinere und grössere Projekte im Bereich Engineering Sie Unterstützen Ihre Direct Reports in der Zusammenarbeit mit den Betreibern der Anlagen, der Abteilung Quality Assurance sowie der Abteilung HSE und sorgen für eine GMP-konforme und sichere Projektausführung Ihr Profil Sie verfügen über eine abgeschlossene Hochschulausbildung als Ingenieur/in, Fachrichtung Verfahrenstechnik, Pharmatechnik, Maschinenbau oder Gebäudetechnik Sie haben fundierte Fachkenntnisse in der Planung und in der Technik von Produktionsanlagen im Life Science- oder Biotechnologie Umfeld Sie verfügen über Führungserfahrung und die Fähigkeit sowohl auf dem Shop-Floor wie auch in der Zusammenarbeit mit dem Top-Management adressatengerecht und versiert zu kommunizieren Sehr gute Deutsch- und Englischkenntnisse sind eine Voraussetzung für die erfolgreiche Ausführung dieser Position Unser Angebot Wir bieten Ihnen eine spannende und herausfordernde Tätigkeit in einem dynamischen und stark wachsenden Umfeld, welches Ihnen Abwechslung und Mitsprache garantiert. Haben wir Ihr Interesse geweckt? Dann freut sich Herr Dominik Ebner (HR Business Partner) auf Ihre vollständigen Bewerbungsunterlagen.
Inserat ansehen
Merken

30.09.2022

Bachem AG

Group Leader QA Project Management (w/m/d) 100%

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 30.09.2022

  • Festanstellung 100%

Festanstellung 100%

4416CH-4416 Bubendorf

Group Leader QA Project Management (w/m/d) 100% Die in der Schweiz gegründete Bachem Gruppe ist ein börsenkotiertes, innovatives Unternehmen, das sich auf die Entwicklung und Herstellung von PepTides und OligonucleoTides spezialisiert hat. Als Full-Service-Provider bietet Bachem Produkte für die klinische Entwicklung und kommerzielle Anwendungen sowie einen umfassenden Katalog und exklusive Auftragssynthesen an. Mit 50 Jahren Erfahrung und Niederlassungen in der Schweiz, den Vereinigten Staaten, Grossbritannien und Japan ist Bachem der Partner der Wahl für die Biotech- und Pharmaindustrie weltweit. Bachem. Leading Partner in Tides Um unser organisches Wachstum weiterführen zu können, sind wir kontinuierlich auf der Suche nach Fachkräften. Für eine neugeschaffene Gruppe innerhalb der Abteilung QA Project Management im Bereich QA/RA suchen wir per sofort oder nach Vereinbarung eine/n motivierte/n Gruppenleiter/in QA Project Management . In dieser verantwortungsvollen Funktion sind Sie zuständig für die Führung und Weiterentwicklung sowohl der Gruppe als auch des Qualitätssystems der Bachem. Sie und Ihre Gruppe leisten im Tagesgeschäft einen direkten und wichtigen Beitrag zu den von der Bachem für den Kunden hergestellten Wirkstoffen. In Zusammenarbeit mit anderen Abteilungen bringen Sie die Projekte erfolgreich durch die Entwicklungsphase bis hin zur Marktreife. Ihre Aufgaben Organisation, Führung und Entwicklung der eigenen Organisationseinheit Sicherstellung der Unterstützung von Projektteams für Entwicklungsprodukte durch kompetente QA-Vertretung Koordination und Sicherstellung der Termineinhaltung von projektbezogenen Aufgaben (z.B. Review von Dokumenten) innerhalb QA Kommunikation zwischen Projektteams, den Fachstellen der Abteilung QA, sowie Schnittstellen und Kunden Prüfung und Genehmigung von projektspezifischen GMP-Dokumenten und deren Änderungen (wie z.B. Spezifikationen, Herstellvorschriften, Analysenvorschriften, Dokumente zur Prozessvalidierung) Sicherstellung der Einhaltung von Qualitätsverträgen Aktive Teilnahme als QA-Vertretung in Projektteams für Entwicklungsprodukte mit den obigen Aufgaben Beratung von anderen Stellen der Bachem AG, insbesondere auf den Gebieten GMP, und Qualitätssicherung Laufende Beobachtung der sich ändernden Pharma-Gesetzgebung und Bachem-interne Umsetzung Entscheid über GMP-relevante Beobachtungen und Abweichungen, Entscheidungen zur GMP-Compliance und zum Qualitätssystem der Bachem Ihr Profil Universitätsabschluss, B.Sc oder M.Sc. in Chemie, Pharmazie oder Naturwissenschaften Mindestens 5 Jahre Berufserfahrung in der Produktion, Qualitätskontrolle oder Qualitätssicherung in der chemischen oder pharmazeutischen Industrie (bevorzugt mit Wirkstoffen) Mindestens 2 Jahre Führungserfahrung Umfassende Kenntnisse der internationalen GMP-Regeln, insbesondere der EU und der USA Hohe Dienstleistungsbereitschaft und Flexibilität gegenüber internen und externen Kunden Schnelle Auffassungsgabe und sehr gute Kommunikationsfähigkeit Hohe Lernbereitschaft und Interesse an Compliance Themen und Produktionsabläufen Sehr gute Englisch- und Deutschkenntnisse in Wort und Schrift Unser Angebot Wir bieten Ihnen eine spannende und herausfordernde Tätigkeit in einem dynamischen Umfeld, welches Ihnen Vielseitigkeit garantiert. Sie werden in ein Team von ausgewiesenen Spezialistinnen und Spezialisten integriert und können sich beruflich entfalten. Zudem bieten wir Ihnen die Möglichkeit in einem innovativen Umfeld und einem motivierten Team mitzuarbeiten. Es erwarten Sie fortschrittliche Anstellungsbedingungen sowie attraktive Nebenleistungen. Wenn Sie sich von diesem interessanten Aufgabenfeld angesprochen fühlen, dann freuen wir uns auf Ihre Bewerbung. Haben wir Ihr Interesse geweckt? Dann freut sich Frau Fabienne Carabelli (HR Business Partner) auf Ihre vollständigen Bewerbungsunterlagen.
Inserat ansehen
Merken

30.09.2022

Bachem AG

Quality Control Scientist

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 30.09.2022

  • Festanstellung 100%

Festanstellung 100%

4416CH-4416 Bubendorf

Quality Control Scientist The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide. Bachem. Leading Partner in Tides In order to continue our organic growth, we are constantly looking for talent. Responsibilities The QC Scientist performs laboratory day-today operations, guides and interacts with QC and department personnel to accomplish goals and objectives as directed by supervisor. Other duties include performing raw material testing, final product testing, QC documentation and related GMP activities. Your Tasks Maintain and perform daily operations of the QC on a daily basis in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc. Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor Implement and maintain GMP procedures such as following SOP’s, Standard Testing Procedures (STP’s), written procedure and maintaining proper documentation as necessary for Quality Control Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy Receive, test and release final product peptide manufactured at Bachem Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy Write standard operating procedures, standard test procedures and other related GMP documentation Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC and misc. wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility. This work may include calibration and validation of these methods Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals Support validation, and stability as necessary to include but not limited to analytical work, documentation and quality GMP procedure Your Profile Bachelor’s Degree in Chemistry or related field Minimum of 3 years’ experience in the GMP industry Use of analytical techniques/ instruments, such as, HPLC, GC, etc. and computer skills Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one’s time Communicate effectively and ability to function well in a team environment Ability to review Certificate of Analysis for Reagents for the creation of specification documents Organization skills to support the department in the creation and approval of controlled documents in a timely manner Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred Experience with Peptides Technical writing experience Master’s degree in Chemistry or related field Experience with Equipment Maintenance Programs Nearest Major Market: San Diego
Inserat ansehen
Merken

30.09.2022

Bachem AG

Lab Technician QC Early Phase (w/m/d)

  • Bachem AG

  • 4416CH-4416 Bubendorf

  • 30.09.2022

  • Festanstellung 100%

Festanstellung 100%

4416CH-4416 Bubendorf

Lab Technician QC Early Phase (w/m/d) Die in der Schweiz gegründete Bachem Gruppe ist ein börsenkotiertes, innovatives Unternehmen, das sich auf die Entwicklung und Herstellung von PepTides und OligonucleoTides spezialisiert hat. Als Full-Service-Provider bietet Bachem Produkte für die klinische Entwicklung und kommerzielle Anwendungen sowie einen umfassenden Katalog und exklusive Auftragssynthesen an. Mit 50 Jahren Erfahrung und Niederlassungen in der Schweiz, den Vereinigten Staaten, Grossbritannien und Japan ist Bachem der Partner der Wahl für die Biotech- und Pharmaindustrie weltweit. Bachem. Leading Partner in Tides Um unser organisches Wachstum weiterführen zu können, sind wir kontinuierlich auf der Suche nach Fachkräften. Wir suchen Das Massenspektrometrie Service Team im analytischen Umfeld sucht eine/n Lab Technician im analytischen Labor. In dieser wichtigen und abwechslungsreichen Position sind Sie als Teil unseres Teams verantwortlich für die Analyse von Startmaterialien bis zum Wirkstoff, auch unter GMP. Unser Schwerpunkt liegt analytisch auf der LC gekoppelten Massenspektrometrie zur Erhebung wichtiger Daten für die Unterstützung der Prozessentwicklung und Charakterisierung unserer Wirkstoffe. Neben Durchführung von Analysen im Routineumfeld nehmen Sie an Optimierungs- und Entwicklungsprojekten teil. Sie sind gern Teil eines agilen Teams, welches sich zusammen den vielfältigen Aufgaben und Fragestellungen eines spannenden Umfeldes stellt. Ihre Persönlichkeit Engagierte und motivierte Persönlichkeit mit Spass an der Arbeit in einem Team Sie sind ein dynamischer Mensch mit Lust auf Verantwortung und Eigeninitiative Teamfähige, zuverlässige, flexible Persönlichkeit Qualitätsbewusste, exakte und dienstleistungsorientierte Arbeitsweise Drive für Innovation und aktives Vorleben von Veränderungen Blick für Prozesszusammenhänge Ihr Profil Abgeschlossene Berufsausbildung als Chemikant/in, Chemielaborant/in, Fachrichtung Analytik oder Synthese Fundierte Berufserfahrung in der analytischen Chemie und instrumenteller Analytik mit Schwerpunkt Chromatographie (HPLC) oder Massenspektrometrie (MS) Kenntnisse in gängigen und im GMP-Umfeld üblichen IT-Applikationen Gute Deutsch- und Englischkenntnisse in Wort und Schrift Wir bieten Es erwartet Sie eine verantwortungsvolle und vielseitige Aufgabe in einem stark wachstumsorientierten Unternehmen mit hervorragenden, persönlichen Entwicklungs- und Aufstiegsmöglichkeiten in einer dynamischen und innovativen Umgebung. Attraktive, zeitgemäße Anstellungsbedingungen sowie fortschrittliche Fringe-Benefits sind selbstverständlich. Wir unterstützen unter anderem öffentliche Verkehrsanbindungen. Haben wir Ihr Interesse geweckt? Dann freut sich Eliane Villani (Senior HR Business Partner) auf Ihre vollständigen Bewerbungsunterlagen.
Inserat ansehen