דרושים Senior Manager Qc Microbiology ב-Incyte ב-שוויץ

Job Summary (Primary function)

Essential Functions of the Job (Key responsibilities)

Performs the QC analysis to support raw materials, production release and stability plan of drug substance (HPLC, UPLC, CGE, pH, FTIR, Osmolality, Protein Concentration or ELISA tests, appearance).

Perform the sampling and the testing of Raw Materials

Performs the review of analytical data.

Act as a a key user for QC equipment software and method setup.

Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.).

Proactively propose problem resolutions

Efficiently contribute to method tech transfer.

Author, review and maintain Standard Operating Procedures, Work Instructions, and other quality control documents.

Supports selection, purchase and commissioning of new equipment.

Supports management supply of QC consumables, reagents and standards.

Supports maintenance/calibration of equipment and keeps relationship with suppliers.

Contribute to the efficient management of samples.

Proactively propose problem resolutions.

Raise, investigate and close events, deviations and non-conformances.

Contribute positively to a strong culture of business integrity and ethics.

Act within compliance and legal requirements as well as within company guidelines.

Qualifications (Minimal acceptable level of education, work experience, and competency)

CFC or higher degree in analytical chemistry/biochemistry

At least 5 years’ experience in the biotech, pharmaceutical or chemical environment

Hands-on experience in a GMP environment and a Quality Control environment.

Good knowledge of analytical method transfer and analytical method validation.

Solid knowledge in spectroscopic, HPLC, CE and ELISA techniques.

Solid knowledge of Empower or Soft Max PRO.

Good writing skills.

Excellent team spirit.

Autonomy

French: Native or Fluent

English: Good knowledge

Knowledge of most common office software.

Work the weekend may be required

ENERGIES, ENVIRONMENT, HEALTH & SAFETY

We ensure the efficient use of our resources and systems, with the aim of optimizing and increasing our energy performance.

We are committed to identifying, record (via EEHS tool), preventing and actively reducing all risks to the health and safety of our employees, through continuous improvement of our processes.

Respecting, promoting and implementing the EEHS policy is an integral part of every function.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

The manager will ensure QA deliverables related to classified rooms and utilities qualification, filling line validation, and overall operational GMP readiness in accordance with cGMP regulations, company policies, and regulatory requirements, including Eudralex GMP Annex 1.

DUTIES AND RESPONSIBILITIES

Project phase – Design, Qualification & Commissioning

·Act as the QA lead in engineering projects involving aseptic filling line, isolator and cleanroom infrastructure.

·Ensure early QA involvement in design and risk assessments, embedding GMP, Annex 1 and data integrity principles into system architecture and process flow.

·Oversee and approve qualification activities (FAT/SAT, IOPQ), ensuring quality requirements are met prior to operational release.

·Lead the QA assessments of change controls and ensure traceability from design to execution.

·Drive quality risk management throughout the project lifecycle supporting a right first-time approach in commissioning and validation

·Support the development and approval of GMP documentation, including SOPs, master batch records and protocol required for the new process or equipment.

·Ensure Annex 1 alignment by integrating contamination control principles, Contamination Control Strategy elements and aseptic process simulation requirements into project deliverables.

·Represent the QA function in project meetings to ensure alignment with technical and regulatory expectations.

Operational phase – Aseptic Manufacturing Operations

·Lead the QA activities related to aseptic filling ensuring compliance with Annex 1 and GMP requirements.

·Ensure timely review and approval of SOPs, deviations, CAPAs, change controls and batch records, maintaining product release timelines and quality standards.

·Be the primary QA contact during regulatory inspections and internal audits, demonstrating mastery of aseptic quality systems and facility knowledge.

·Lead by example in the cleanroom environment and foster an aseptic mindset, supporting all team members in maintaining the highest standards of sterility assurance

·Analyze Quality KPIs, lead continuous improvement initiatives and escalate quality trends to management

·Support Inspection readiness activities and represent QA function for engineering and manufacturing related matters in Health Authorities inspections

·Collaborate with cross-functional teams, including production, engineering, and manufacturing sciences, to drive quality and operational excellence.

·Promote a culture of compliance and continuous improvement throughout the project lifecycle.

·Ensure all activities comply with safety requirements, company policies, and applicable regulations.

REQUIREMENTS

·Demonstrated experience in qualification, validation and GMP operations.

·Significant experience in aseptic process activities (experience in isolator technology is an asset). Candidates with equivalent relevant experience are encouraged to apply

·Extensive experience in Quality Assurance oversight of pharmaceutical manufacturing projects. Candidates with equivalent relevant experience are encouraged to apply.

·Academic degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering, or related field).

·Strong knowledge of cGMP and international regulatory requirements for facility qualification and process validation.

·Strong knowledge of Eudralex GMP Annex 1 and Sterility Assurance concepts.

·Strong analytical and problem-solving skills.

·Excellent verbal and written communication skills with a structured approach.

·Fluent in French (written and spoken); proficiency in English is an asset.

·Ability to work independently and collaborate with multidisciplinary teams.

The aforementioned activities can be delegated to the QA Manager Tech. Transfer, to the QA Manager Operations and Engineering and to the QA Associate Directors.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

Essential Functions of the Job (Key responsibilities)

·Performs the sampling and the testing of Raw Materials

·Performs analytical raw data review related to the sampling and testing of Raw Materials

·Actively contributes to method implementation and equipment implementation.

·Act as a key user for QC equipment software and method setup.

·Performs basic laboratory work (buffer preparation, waste disposal management, washing of lab dishes, cleaning of the labs etc.).

·Proactively propose problem resolutions

·Efficiently contribute to method tech transfer.

·Author, review and maintain Standard Operating Procedures, Work Instructions, and other quality control documents.

·Supports selection, purchase and commissioning of new equipment.

·Supports management supply of QC consumables, reagents and standards.

·Supports maintenance/calibration of equipment and keeps relationship with suppliers.

·Contribute to the efficient management of samples.

·Proactively propose problem resolutions.

·Raise, investigate and close events, deviations and non-conformances.

·Contribute positively to a strong culture of business integrity and ethics.

·Act within compliance and legal requirements as well as within company guidelines.

Qualifications (Minimal acceptable level of education, work experience, and competency)

·CFC or higher degree in analytical chemistry/biochemistry

·At least 5 years’ experience in the biotech, pharmaceutical or chemical environment

·Hands-on experience in a GMP environment and a Quality Control environment.

·Good knowledge of analytical method transfer and analytical method validation.

·Solid knowledge in spectroscopic techniques.

·Good writing skills.

·Excellent team spirit.

·Autonomy

·French: Native or Fluent

·English: Basic knowledge

·Knowledge of most common office software.

·Work the weekend may be required.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

This includes (but is not limited to) the planification of testing, the definition of the analyses to be carried out, the management of sampling (plan and execute), the management of internal & external results/data review and their approval within the defined lead time.

The QC Lab Supervisor owns the deviations, CAPA and change controls for the QC activities under his/her responsibilities.

Essential Functions of the Job (Key responsibilities)

Leadership & Management

·Supervise, mentor, and develop QC analysts in the physico-chemistry laboratory.

·Plan and allocate daily laboratory activities to meet testing schedules and manufacturing timelines.

Laboratory Operations

·Accountable for the routine and non-routine QC Physico-Chemistry testing of in-process samples, drug substances with a variety of physico-chemical methods (e.g., HPLC, UPLC, CE, SoloVPE, ELISA.).

·Ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and all relevant regulatory standards (FDA, EMA, ICH).

·Ensures that all QC equipment are appropriately qualified and fit for purpose for cGMPs activities

·Troubleshoots analytical instruments, assays, and technical issues to maintain laboratory efficiency.

Quality & Compliance

·Review and approve laboratory data, test results, and associated documentation.

·Conducts investigations of out-of-specification (OOS), deviations, and non-conformances.

·Maintain up-to-date SOPs, protocols, and training records to ensure regulatory compliance.

·Participate in audits and inspections

Continuous Improvement & Projects

·Drive laboratory process improvements, automation, and digitalization initiatives.

·Participate in method validation, transfer, and lifecycle management projects.

·Collaborate with cross-functional teams (Manufacturing, QA, Regulatory Affairs, Development) to support product lifecycle and inspections.

·Provide inputs for establishing the QC laboratory budget and operating in the defined approved budget

Qualifications (Minimal acceptable level of education, work experience, and competence)

·Bachelor (in Physico-chemistry, Biotechnology) with 10 years or higher degree (in Physico-chemistry, Biotechnology) with at least 10 years of experience in a laboratory environment.

·Strong experience in a GMP environment, in a biotechnology or pharmaceutical company.

·QC Laboratory supervision experience required demonstrated ability to set vision and direction for a team including setting expectations and motivating results Experience with Quality systems such as Deviation, CAPA, Change Control systems required

·Deep knowledge of Analytical testing and Pharmacopoeias

·Ability to work in a highly regulated and fast-changing environment

·Highly developed team spirit

·Proactivity and pragmatism

·Rigorous and organized

·Be able to make proposals

·Have a spirit of synthesis

·Language: French (fluent) and English (advanced; C1)

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Responsibility for managing and maintaining existing development and marketing authorization dossiers and compiling submissions in compliance with ICH specifications and Health Authority regulations globally. Co-ordination with functional leads in various disciplines to ensure compliant documents, maintain regulatory information and the physical and electronic regulatory archives, mentor on eCTD requirements and other duties and/or special projects as assigned or required.

Duties and Responsibilities

·Responsible for the timely planning, compiling, publishing, review and delivery of compliant regulatory submissions to Regulatory Health Authorities.

·Ensures documents comply with submission ready standards and guidelines and provides guidance with respect to requirements.

·Maintains and archives all regulatory correspondence in appropriate systems.

·Liaises with vendors for submission support, as needed.

·Participates in validation or verification testing of templates, electronic document management system, information management and document/submission publishing related tools.

·Provides expertise and support to the user community for RIM systems and EDMS.

·Maintains tracking tools and systems for regulatory information, including submission content plans.

·Support other areas of the company (eg., Business Development) concerning regulatory documentation, as needed.

·Maintains current working instructions for regulatory-related systems (e.g. publishing software, RIM and EDMS.

·Mentors others on submission processes and requirements and may manage contract Regulatory Operations personnel.

·Contribute positively to a strong culture of business integrity and ethics.

·Act within compliance and legal requirements as well as within company guidelines.

·Coordinate the preparation and review of documents for regulatory submissions (e.g. cover letters, forms, DSURs, safety reports, etc.).

·Participates in the preparation of dossiers containing manufacturing, preclinical, and clinical data.

·Provides guidance to authors for clear document and data presentation and location in order to optimize submission navigation as well as the regulatory review and approval process.

·Analyze and continuously improve work practices and guidelines and organize and conduct training on behalf of the Regulatory Operations team as appropriate.

·Remain current on knowledge of industry trends relevant to global electronic submissions and interface systems with Health Agencies for all regions

Requirements

·Bachelor degree (in science, technology, health- related field, or business management preferred) or equivalent experience.

·Relevant experience in a regulatory affairs environment with document management systems, electronic publishing systems and electronic submissions, including eCTD, CTAs, direct submission to global Health Authorities.

·Experience in drug development and knowledge of global regulatory submission content and formats.

·Experience with packaging and labelling, and combination products submissions preferred.

·Strong technical knowledge and working skills in publishing and related computer software including advanced MS Word, Adobe and Adobe plug-ins.

·Excellent organization, communication and writing skills.

·Ability to manage multiple priorities and projects.

·Strong attention to detail and quality.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

The Senior Cybersecurity Architect is responsible for developing security architecture across all technology stacks, including on-premises, cloud (AWS / Azure / SaaS) environments. This role requires hands-on technical skills needed for evaluating, selecting, implementing and managing cybersecurity tools and technologies. It also needs working closely with business, infrastructure, and other IT teams to assure security for a variety of technology solutions. s. Additionally, the Senior Cybersecurity Architect will manage consulting resources and lead projects to ensure the organization’s security posture aligns with industry best practices and organizational goals.

***This is a 4-day on-site position***

Essential Functions of the Job (Key responsibilities)

·Develop cybersecurity architecture, ensuring alignment with organizational goals and industry best practices across all technology stacks, including on-premises, cloud, to manage current and merging security risks.

·Lead the evaluation and selection, implementation and management of comprehensive security solutions, ensuring robust protection for the organization’s assets.

·Conduct vulnerability assessments, penetration testing, and security reviews, collaborating with various teams on remediation efforts.

·Provide expert guidance on security controls and best practices for both on-premises and cloud-based solutions to IT and business teams.

·Perform detailed security investigations, document findings and recommendations for complex incidents, and resolve issues while preserving forensic evidence.

·Identify and implement continuous improvements in security-related processes and technologies.

·Mentor other cybersecurity professionals in the team, to upskill them to meet the organizational requirements

·Lead and manage cybersecurity projects, ensuring timely delivery and alignment with organizational objectives.

·Collaborate with the Security Operations Center (SOC) and other teams to enhance detection and response capabilities.

Qualifications (Minimal acceptable level of education, work experience, and competency)

·7 - 10 years of experience in IT with a focus on Cybersecurity and Cloud security services.

·4+ years of Cloud Security architecture experience.

·Relevant certifications (e.g., CISSP, CCSP, AWS/Azure Certified Security Solutions architect) preferred.

·Proven experience in managing and leading cybersecurity teams and projects.

·Extensive knowledge of networking protocols and technologies, network security architecture, and engineering.

·Expertise in cloud (AWS andAzure) and on-premises security and related technologies.

·In-depth knowledge and experience with various security tools and technologies, including End-Point Security, SIEM, DLP, IRM, vulnerability assessment, and patch management.

·Comprehensive understanding of risk and vulnerability mitigation.

·Knowledge of security standards and guidelines from NIST and SANS.

·Extensive hands-on administrative experience with infrastructure and/or automation tools including but not limited to Windows/Linux and other OS and/or modern cloud service plans.

·Basic knowledge of ITIL.

·Strong project management skills, including experience with project planning, execution, and monitoring.

·Excellent relationship-building skills with both internal and external stakeholders.

·Strong organizational and communication skills.

·Must be a self-starter and work well independently, as well as within a team environment.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .