Celgene
Neuenburgersee, Boudry, Switzerland
On the Quality Control team, we deliver our mission by testing raw materials, drug substance (API), drug product (Bulk) and stability samples for oral solid dosage forms manufactured at the site. The Scientist will provide technical and scientific expertise to support acquisition and qualification of new equipment, investigation and troubleshooting of analytical and equipment issues as well as introduction of new products to the QC laboratories. Additional duties will include performing superuser activities for the laboratory computerized systems, representing QC in cross-functional projects (e.g. for new product implementation) and participating in internal and external audits as Subject Matter Expert (SME). This position is primarily located at the Celgene site in Boudry. The Scientist may also be assigned responsibilities for activities or systems located at the Celgene site in Couvet. As the Quality Control Scientist, Technical Support , you will be :
Responsible for acquisition and qualification of new analytical equipment:
Works cross-functionally with the Analytical Development, QC, IT and Validation departments to select, purchase and qualify new analytical equipment for the QC laboratories. Owns the change control, leads or supports risk assessments, Performs feasibility experimental work as needed Configures user-profiles and methods on the instrument. Collaborates with Validation and Sourcing to define requirements and contracts for the periodic maintenance and requalification of the equipment.
Using scientific and technical expertise to investigate and resolve technical issues in the laboratory.
Owns deviations. Leads or supports laboratory investigations in case of out of specification or out of trend result. Writes investigational testing plans to identify laboratory root cause. Defines corrective and preventive actions (CAPA).
Representing QC in project teams (e.g. for new product introductions to the site)
Represents QC in cross-functional project teams, interacting with Project Management Office, Manufacturing, Analytical Development, Analytical Science and Technology. Supports QC management in identifying needs for new equipment and assessing impact on laboratory systems and processes as well as on resource planning. Leads or supports risk assessments, owns change controls. Reviews method transfer plans. Performs or supports feasibility experimental work as needed. Supports method transfer, method verification and method validation activities.
Maintaining the GMP status of the laboratory and analytical methods.
Performs all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures. Evaluates the impact of compendial changes on applicable QC procedures and opens change controls as required. Actively participates in inspections by health authorities and in corresponding preparation.
Superuser of laboratory computerized systems:
Administers user-profiles and access to the systems, Defines requirements and performs audit trail reviews, assures adherence to data integrity principles, Authors instrument/system operating procedures and trains QC analysts on use of the system. Performs master data management activities in computerized systems (LIMS, Oracle, Empower). Knowledge and skills required
BS degree in Life Sciences, Chemistry, or equivalent;
5 years of work experience in a GMP environment (pharmaceutical industry)
Advanced knowledge and interpretation of cGMP and Pharmacopeia requirements
Excellent scientific knowledge and hands-on experience of chromatography techniques (HPLC, UPLC, GC), dissolution, UV/VIS and IR techniques.
Experience of analytical testing according to Ph. Eur. and USP requirements.
Experience in analytical method transfers and analytical method validation/verification.
Experience in laboratory equipment qualification.
General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, Empower, LIMS).
Good knowledge of Data Integrity principles, familiar with audit trail review requirements.
Effective verbal communication skills, ability to interact with different levels of the organization: supervisor, peers, lab analysts, and other departments
Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations.
Takes a structured and analytical approach to problem-solving. Is familiar with problem-solving and investigation tools and methodologies.
Ability to work collaboratively and cross-functionally in project teams.
Fluent in English or French and professional command of the second language (written and verbal)
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies
On the Quality Control team, we deliver our mission by testing raw materials, drug substance (API), drug product (Bulk) and stability samples for oral solid dosage forms manufactured at the site. The Scientist will provide technical and scientific expertise to support acquisition and qualification of new equipment, investigation and troubleshooting of analytical and equipment issues as well as introduction of new products to the QC laboratories. Additional duties will include performing superuser activities for the laboratory computerized systems, representing QC in cross-functional projects (e.g. for new product implementation) and participating in internal and external audits as Subject Matter Expert (SME). This position is primarily located at the Celgene site in Boudry. The Scientist may also be assigned responsibilities for activities or systems located at the Celgene site in Couvet. As the Quality Control Scientist, Technical Support , you will be :
Responsible for acquisition and qualification of new analytical equipment:
Works cross-functionally with the Analytical Development, QC, IT and Validation departments to select, purchase and qualify new analytical equipment for the QC laboratories. Owns the change control, leads or supports risk assessments, Performs feasibility experimental work as needed Configures user-profiles and methods on the instrument. Collaborates with Validation and Sourcing to define requirements and contracts for the periodic maintenance and requalification of the equipment.
Using scientific and technical expertise to investigate and resolve technical issues in the laboratory.
Owns deviations. Leads or supports laboratory investigations in case of out of specification or out of trend result. Writes investigational testing plans to identify laboratory root cause. Defines corrective and preventive actions (CAPA).
Representing QC in project teams (e.g. for new product introductions to the site)
Represents QC in cross-functional project teams, interacting with Project Management Office, Manufacturing, Analytical Development, Analytical Science and Technology. Supports QC management in identifying needs for new equipment and assessing impact on laboratory systems and processes as well as on resource planning. Leads or supports risk assessments, owns change controls. Reviews method transfer plans. Performs or supports feasibility experimental work as needed. Supports method transfer, method verification and method validation activities.
Maintaining the GMP status of the laboratory and analytical methods.
Performs all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures. Evaluates the impact of compendial changes on applicable QC procedures and opens change controls as required. Actively participates in inspections by health authorities and in corresponding preparation.
Superuser of laboratory computerized systems:
Administers user-profiles and access to the systems, Defines requirements and performs audit trail reviews, assures adherence to data integrity principles, Authors instrument/system operating procedures and trains QC analysts on use of the system. Performs master data management activities in computerized systems (LIMS, Oracle, Empower). Knowledge and skills required
BS degree in Life Sciences, Chemistry, or equivalent;
5 years of work experience in a GMP environment (pharmaceutical industry)
Advanced knowledge and interpretation of cGMP and Pharmacopeia requirements
Excellent scientific knowledge and hands-on experience of chromatography techniques (HPLC, UPLC, GC), dissolution, UV/VIS and IR techniques.
Experience of analytical testing according to Ph. Eur. and USP requirements.
Experience in analytical method transfers and analytical method validation/verification.
Experience in laboratory equipment qualification.
General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, Empower, LIMS).
Good knowledge of Data Integrity principles, familiar with audit trail review requirements.
Effective verbal communication skills, ability to interact with different levels of the organization: supervisor, peers, lab analysts, and other departments
Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations.
Takes a structured and analytical approach to problem-solving. Is familiar with problem-solving and investigation tools and methodologies.
Ability to work collaboratively and cross-functionally in project teams.
Fluent in English or French and professional command of the second language (written and verbal)
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies
Celgene
Neuenburgersee, Boudry, Switzerland
Req #: 1903685 Location: Boudry, Neuchatel, Switzerland Job Category: Medical Work Location: Route de Perreux 1 2017 Organization: Clinical Research Scientist Employee Status: Full-time Job Type: Temporary
Here at Celgene, we are seeking an experienced and self-sufficient Clinical professional to play a pivotal role in the progress of our CAR T clinical work, and to join our team as Clinical Research Scientist. As we seek to push the boundaries of medical innovation, we are seeking an individual who is knowledgeable / well-versed in verifying and reviewing clinical data - you will, therefore, have experience from either a Clinical Research Organisation (CRO) or a pharma/biotech setting, As a Clinical Research Scientist, you will play a key role within the Lymphoma Team. Working closely with the study team, you will support the clinical study activities as well as collaborate with clinical team members - you will also liaise closely with non-Clinical team members as to provide deliverables. Because of this, it is essential that you have experience from within Hematology or Oncology. In this role, you will be empowered to achieve your personal goals which support study team and project team goals - this will be aided by your colleagues, a diverse and experienced set of individuals who form the Global team. Please note: This is a 12-month temporary assignment, based out of our International HQ in Neuchatel, Switzerland. (due to acute business needs, preference will be given to those candidates who are already located in Switzerland and available at short notice) Responsibilities will include, but are not limited to, the following:
Support assigned study level activities with a minimal level of supervision (may lead or co-lead a study or study activities)
Thorough understanding of assigned protocol and protocol requirements
Successfully plans execution of deliverables
Support all study start-up/conduct/close-out activities as applicable
Preparation, storage, maintenance of clinical documents (TMF)
Coordination of protocols & amendments; may author with guidance
Review and validation of clinical study reports (CSRs); demonstrate basic understanding the connection between the data and the CSR
Conduct literature review as needed
Provide study related information to support Regulatory Documents (e.g., IB, Briefing Books)
Review Informed Consent Forms (ICF); may author a global or regional ICF template
Preparation of site and CRA training materials; may present information
Country/site selection activities as requested
Collaboration with Clinical Operations for budget preparation, CRO scope, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes)
Support study committee (e.g., DMC) activities (e.g., charters, meetings, presentations)
Support Investigator Meeting and SIV planning/facilitation, including slide preparation
Review clinical data for specific trends, mine data to support responses to HA or EC questions as requested
Clinical review of study data (conduct clinical data review, communicate as necessary to resolve data queries, draft/update/review data review plans, support Clinical Research Physician in data review (generation of reports, action plans, trend identification), etc)
Collaborate with study team members including: Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management (set-up and/or lead meetings as appropriate)
Regularly attend and actively participate in study team and other clinical meetings.
Seek out and enact best practices with minimal instruction; contribute to process improvement.
Actively seek and receive coaching/mentoring; may provide guidance to junior members of team.
Contribute to preparations for external/stakeholder meetings (e.g., IMs, Governance)
May present data/information to external investigators or study staff (e.g., SIV presentations)
Provide regular and timely updates to manager
Identify & escalate current/future issues; may propose solutions
Set own priorities with moderate guidance from manager.
IN MANAGER's WORDS, the top 3 requirements are: 1. Clinical/Medical background and experience as a Clinical Research Scientist 2. Must have at least two years of direct HEMATOLOGY/ONCOLOGY experience in a Clinical Research and Development capacity 3. Must be able to function independently Skills/Knowledge Required :
At least 4 years of experience in CR&D roles/responsibilities or equivalent
Knowledge of GCP/ICH, overall drug development process from discovery to registration, study design, statistics, clinical operations
Excellent verbal, written, communication and interpersonal skills
Demonstrates initiative
Detail-oriented
Knowledge and skills to support program specific data review and trend identification
Knowledge of Medical Terminology and basic medical writing skills
Knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA & safety profile)
Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
Understanding of functional and cross-functional relationships
Commitment to Quality
Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Strong planning/project management skills (ability to develop short range plans that are realistic and effective in meeting goals)
Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Req #: 1903685 Location: Boudry, Neuchatel, Switzerland Job Category: Medical Work Location: Route de Perreux 1 2017 Organization: Clinical Research Scientist Employee Status: Full-time Job Type: Temporary
Here at Celgene, we are seeking an experienced and self-sufficient Clinical professional to play a pivotal role in the progress of our CAR T clinical work, and to join our team as Clinical Research Scientist. As we seek to push the boundaries of medical innovation, we are seeking an individual who is knowledgeable / well-versed in verifying and reviewing clinical data - you will, therefore, have experience from either a Clinical Research Organisation (CRO) or a pharma/biotech setting, As a Clinical Research Scientist, you will play a key role within the Lymphoma Team. Working closely with the study team, you will support the clinical study activities as well as collaborate with clinical team members - you will also liaise closely with non-Clinical team members as to provide deliverables. Because of this, it is essential that you have experience from within Hematology or Oncology. In this role, you will be empowered to achieve your personal goals which support study team and project team goals - this will be aided by your colleagues, a diverse and experienced set of individuals who form the Global team. Please note: This is a 12-month temporary assignment, based out of our International HQ in Neuchatel, Switzerland. (due to acute business needs, preference will be given to those candidates who are already located in Switzerland and available at short notice) Responsibilities will include, but are not limited to, the following:
Support assigned study level activities with a minimal level of supervision (may lead or co-lead a study or study activities)
Thorough understanding of assigned protocol and protocol requirements
Successfully plans execution of deliverables
Support all study start-up/conduct/close-out activities as applicable
Preparation, storage, maintenance of clinical documents (TMF)
Coordination of protocols & amendments; may author with guidance
Review and validation of clinical study reports (CSRs); demonstrate basic understanding the connection between the data and the CSR
Conduct literature review as needed
Provide study related information to support Regulatory Documents (e.g., IB, Briefing Books)
Review Informed Consent Forms (ICF); may author a global or regional ICF template
Preparation of site and CRA training materials; may present information
Country/site selection activities as requested
Collaboration with Clinical Operations for budget preparation, CRO scope, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes)
Support study committee (e.g., DMC) activities (e.g., charters, meetings, presentations)
Support Investigator Meeting and SIV planning/facilitation, including slide preparation
Review clinical data for specific trends, mine data to support responses to HA or EC questions as requested
Clinical review of study data (conduct clinical data review, communicate as necessary to resolve data queries, draft/update/review data review plans, support Clinical Research Physician in data review (generation of reports, action plans, trend identification), etc)
Collaborate with study team members including: Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management (set-up and/or lead meetings as appropriate)
Regularly attend and actively participate in study team and other clinical meetings.
Seek out and enact best practices with minimal instruction; contribute to process improvement.
Actively seek and receive coaching/mentoring; may provide guidance to junior members of team.
Contribute to preparations for external/stakeholder meetings (e.g., IMs, Governance)
May present data/information to external investigators or study staff (e.g., SIV presentations)
Provide regular and timely updates to manager
Identify & escalate current/future issues; may propose solutions
Set own priorities with moderate guidance from manager.
IN MANAGER's WORDS, the top 3 requirements are: 1. Clinical/Medical background and experience as a Clinical Research Scientist 2. Must have at least two years of direct HEMATOLOGY/ONCOLOGY experience in a Clinical Research and Development capacity 3. Must be able to function independently Skills/Knowledge Required :
At least 4 years of experience in CR&D roles/responsibilities or equivalent
Knowledge of GCP/ICH, overall drug development process from discovery to registration, study design, statistics, clinical operations
Excellent verbal, written, communication and interpersonal skills
Demonstrates initiative
Detail-oriented
Knowledge and skills to support program specific data review and trend identification
Knowledge of Medical Terminology and basic medical writing skills
Knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA & safety profile)
Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
Understanding of functional and cross-functional relationships
Commitment to Quality
Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Strong planning/project management skills (ability to develop short range plans that are realistic and effective in meeting goals)
Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients." There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
