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Most recent job postings at Y-mAbs Therapeutics
via Indeed
posted_at: 27 days agoschedule_type: Full-time
Y-mAbs Therapeutics is looking for a Principal Scientist, Assay Development for our R&D Science, non-
clinical Development and Translational Medicine department located in Hørsholm, Denmark...
Y-mAbs is a late-stage clinical, global biopharmaceutical company focused on the development and
commercialization of novel, antibody-based therapeutic products for the treatment of cancer. We have
a broad and advanced product pipeline, including pivotal-stage
Y-mAbs Therapeutics is looking for a Principal Scientist, Assay Development for our R&D Science, non-
clinical Development and Translational Medicine department located in Hørsholm, Denmark...
Y-mAbs is a late-stage clinical, global biopharmaceutical company focused on the development and
commercialization of novel, antibody-based therapeutic products for the treatment of cancer. We have
a broad and advanced product pipeline, including pivotal-stage product candidates against a range of
targets and including one FDA-approved product (Naxitamab).
Primary Responsibilities
As Principal Scientist, Assay Development at Y-mAbs, you will play a key role in assay development,
analytical method development, and validation activities for biochemical assays. This responsibility
involves optimization for non-clinical and clinical assays and therapeutic protein drugs.
The candidate will be responsible for:
• Establish overall development plans for current and upcoming assays.
• Contracting with bioanalytical CROs (PK, ADA, DFA, and biomarker), including oversight,
troubleshooting, and ensuring that the right compound quality and documentation are available at
CROs.
• Collaborate on development and validation/qualification of preclinical assays (PK, ADA, and dose-
formulation (DFA) assays), non-GLP, and GLP quality.
• Input to sampling time points in preclinical studies and PK calculation of PK data (non-GLP).
• Development and validation of clinical PK, ADA, and biomarker assays (GLP/GCLP quality).
• Bioanalytical input to clinical documents (protocols, lab manuals, and central lab documents) incl.,
review of the documents.
• Bioanalytical and PK Input to regulatory documents (pre-IND, IND).
• Review of bioanalytical protocols and reports obtained from CROs.
• Budget input and follow-up of costs.
• Establish timelines and coordinate assay development/optimization in alignment with a project
timeline.
• Review reports.
Required Qualifications
You have more than 5 years of work experience in the biotechnology or pharmaceutical industry in cell
therapy or Biologics. You have a solid scientific background in cellular biology and cell culture systems.
You possess expertise in developing cell-based assays using analytical methods such as IHC, PK, ADA,
etc.
You understand regulatory requirements for method validation under GMP, have experience with
defining specifications, and can interpret data. You are preferably fluent in Danish, written as spoken.
You have a degree-level qualification in Chemistry, Biochemistry, Pharmacology, Biology, or equivalent.
Success criteria
You are a dedicated, result-oriented team player who enjoys working in an innovative and passionate
environment. You are proactive and self-driven, excellent at multi-tasking, have an entrepreneurial work
approach, and can navigate a matrix organization across different departments and functions. Your ability
to build strong working relationships is key.
Travelling
You will be travelling approx. 10 days per year.
Y-mAbs employees are based both in Denmark and the US. This position is based in Denmark.
To apply
Unique Human Capital (UHC) will assist in the recruitment process. You can apply through UHC website
directly – click this link Principal Scientist, Assay Development TM or by sending an email to
HR@ymabs.com. Please mark your application with Job ID no. 1079. Your application must be in English
and will be treated confidentially.
Y-mAbs Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to
creating an inclusive environment for all employees.
Y-mAbs Therapeutics Inc. has a Danish affiliate Y-mAbs Therapeutics A/S, located in Hørsholm,
Denmark. Our mission is to discover, develop and deliver novel antibody therapeutics for the treatment
of both pediatric and adult cancer patients.
Please access the company web site www.ymabs.com for more information regarding the company and
our development projects Show more details...
clinical Development and Translational Medicine department located in Hørsholm, Denmark...
Y-mAbs is a late-stage clinical, global biopharmaceutical company focused on the development and
commercialization of novel, antibody-based therapeutic products for the treatment of cancer. We have
a broad and advanced product pipeline, including pivotal-stage product candidates against a range of
targets and including one FDA-approved product (Naxitamab).
Primary Responsibilities
As Principal Scientist, Assay Development at Y-mAbs, you will play a key role in assay development,
analytical method development, and validation activities for biochemical assays. This responsibility
involves optimization for non-clinical and clinical assays and therapeutic protein drugs.
The candidate will be responsible for:
• Establish overall development plans for current and upcoming assays.
• Contracting with bioanalytical CROs (PK, ADA, DFA, and biomarker), including oversight,
troubleshooting, and ensuring that the right compound quality and documentation are available at
CROs.
• Collaborate on development and validation/qualification of preclinical assays (PK, ADA, and dose-
formulation (DFA) assays), non-GLP, and GLP quality.
• Input to sampling time points in preclinical studies and PK calculation of PK data (non-GLP).
• Development and validation of clinical PK, ADA, and biomarker assays (GLP/GCLP quality).
• Bioanalytical input to clinical documents (protocols, lab manuals, and central lab documents) incl.,
review of the documents.
• Bioanalytical and PK Input to regulatory documents (pre-IND, IND).
• Review of bioanalytical protocols and reports obtained from CROs.
• Budget input and follow-up of costs.
• Establish timelines and coordinate assay development/optimization in alignment with a project
timeline.
• Review reports.
Required Qualifications
You have more than 5 years of work experience in the biotechnology or pharmaceutical industry in cell
therapy or Biologics. You have a solid scientific background in cellular biology and cell culture systems.
You possess expertise in developing cell-based assays using analytical methods such as IHC, PK, ADA,
etc.
You understand regulatory requirements for method validation under GMP, have experience with
defining specifications, and can interpret data. You are preferably fluent in Danish, written as spoken.
You have a degree-level qualification in Chemistry, Biochemistry, Pharmacology, Biology, or equivalent.
Success criteria
You are a dedicated, result-oriented team player who enjoys working in an innovative and passionate
environment. You are proactive and self-driven, excellent at multi-tasking, have an entrepreneurial work
approach, and can navigate a matrix organization across different departments and functions. Your ability
to build strong working relationships is key.
Travelling
You will be travelling approx. 10 days per year.
Y-mAbs employees are based both in Denmark and the US. This position is based in Denmark.
To apply
Unique Human Capital (UHC) will assist in the recruitment process. You can apply through UHC website
directly – click this link Principal Scientist, Assay Development TM or by sending an email to
HR@ymabs.com. Please mark your application with Job ID no. 1079. Your application must be in English
and will be treated confidentially.
Y-mAbs Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to
creating an inclusive environment for all employees.
Y-mAbs Therapeutics Inc. has a Danish affiliate Y-mAbs Therapeutics A/S, located in Hørsholm,
Denmark. Our mission is to discover, develop and deliver novel antibody therapeutics for the treatment
of both pediatric and adult cancer patients.
Please access the company web site www.ymabs.com for more information regarding the company and
our development projects Show more details...
via Salary.com
schedule_type: Full-time
Come join our dedicated regulatory team! Y-mAbs Therapeutics A/S (Y-mAbs) is now
looking for a Regulatory Affairs Manager for a 9-month maternity cover with the...
possibility of extension to support the Life Cycle Management & Development activities
within Global Regulatory Affairs.
Y-mAbs is a fast-paced, late-stage clinical biopharmaceutical company focused on the
development and commercialization of novel, antibody-based therapeutic products
Come join our dedicated regulatory team! Y-mAbs Therapeutics A/S (Y-mAbs) is now
looking for a Regulatory Affairs Manager for a 9-month maternity cover with the...
possibility of extension to support the Life Cycle Management & Development activities
within Global Regulatory Affairs.
Y-mAbs is a fast-paced, late-stage clinical biopharmaceutical company focused on the
development and commercialization of novel, antibody-based therapeutic products for
the treatment of cancer. It is expanding rapidly, following approval of its first product in
November 2020 and second product anticipated approval later this year. The company
has a broad and interesting pipeline with several compounds in clinical development
As a Regulatory Affairs Manager you will support the LCM team in building up the
necessary structure, procedures, and systems required for Y-mAbs to handle new
markets and LCM activities. You will support planning and execute LCM activities and
geographic expansion together with the LCM RA team, key internal stakeholders and
external partners. You will report to the Life Cycle Management Lead of Global
Regulatory Affairs. Furthermore, you will in collaboration with the Regulatory Project
Leads support our development projects (CTAs / INDs) and be an important contributor
in preparing responses to Biologic License Application Requests.
Key responsibilities
• Support Life Cycle Management activities of marketed products globally incl.
annual reports, safety update submissions (PSURs/DSURs/PADERs) in close
collaboration with our CROs or external partners
• Involved in review of change controls to support post-approval changes globally
• Preparation of country specific documents supporting new Marketing
Authorization Applications (MAAs) and post-approval submissions
• Tracking and documenting Health Authority correspondence, submissions and
commitments in our regulatory information management (RIM) database
• Contribute to the continuous improvement of Y-mAbs’ procedures and secure
best practices
Personal and professional qualifications
• MSc within natural science e.g. biology, pharmaceutical science or equivalent
• You are structured, organized, and have good coordinating skills
• You are flexible and enjoy handling multiple tasks at the same time
• You take responsibility and work independently, but at the same time you are a
strong team player
• You have experience in document management
• You can work with ambitious timelines in our slim organization with a cross-
functional team
Y-mAbs Therapeutics A/S, Agern Allé 11, 2970 Hørsholm, Denmark, Tel: 45 7026 1414 www.ymabs.com
• You preferably have 1-2 years’ regulatory experience, maybe through student
work in Regulatory Affairs, and some knowledge of regulatory requirements
• You are result-oriented and committed to contributing to the overall success of
Y-mAbs
• Our company language is English, so your communication in both written and
spoken English is fluent
For more details about the job or our company, please contact VP of Regulatory Affairs,
Rikke Valentin Oxholm at 45 53 88 02 88 or Daniel Dam Doktor, RA LCM Lead at 45
53 88 01 65.
Your application must be submitted in English and will be treated confidentially.
You can apply for the position by sending an email to HR@ymabs.com. Please mark your
application with Job ID no. 1074.
Deadline for applications: 18 July 2022. We will initiate interviews in a rolling manner as
applications are received.
Y-mAbs Therapeutics A/S is located in Hørsholm, Denmark - a Danish affiliate of Y-mAbs
Therapeutics Inc.. Our mission is to discover, develop and deliver novel antibody
therapeutics for the treatment of both pediatric and adult cancer patients.
Please access the company website www.ymabs.com for more information regarding
the company and our development projects.
Y-mAbs Therapeutics A/S, Agern Allé 11, 2970 Hørsholm, Denmark, Tel: 45 7026 1414 www.ymabs.com Show more details...
looking for a Regulatory Affairs Manager for a 9-month maternity cover with the...
possibility of extension to support the Life Cycle Management & Development activities
within Global Regulatory Affairs.
Y-mAbs is a fast-paced, late-stage clinical biopharmaceutical company focused on the
development and commercialization of novel, antibody-based therapeutic products for
the treatment of cancer. It is expanding rapidly, following approval of its first product in
November 2020 and second product anticipated approval later this year. The company
has a broad and interesting pipeline with several compounds in clinical development
As a Regulatory Affairs Manager you will support the LCM team in building up the
necessary structure, procedures, and systems required for Y-mAbs to handle new
markets and LCM activities. You will support planning and execute LCM activities and
geographic expansion together with the LCM RA team, key internal stakeholders and
external partners. You will report to the Life Cycle Management Lead of Global
Regulatory Affairs. Furthermore, you will in collaboration with the Regulatory Project
Leads support our development projects (CTAs / INDs) and be an important contributor
in preparing responses to Biologic License Application Requests.
Key responsibilities
• Support Life Cycle Management activities of marketed products globally incl.
annual reports, safety update submissions (PSURs/DSURs/PADERs) in close
collaboration with our CROs or external partners
• Involved in review of change controls to support post-approval changes globally
• Preparation of country specific documents supporting new Marketing
Authorization Applications (MAAs) and post-approval submissions
• Tracking and documenting Health Authority correspondence, submissions and
commitments in our regulatory information management (RIM) database
• Contribute to the continuous improvement of Y-mAbs’ procedures and secure
best practices
Personal and professional qualifications
• MSc within natural science e.g. biology, pharmaceutical science or equivalent
• You are structured, organized, and have good coordinating skills
• You are flexible and enjoy handling multiple tasks at the same time
• You take responsibility and work independently, but at the same time you are a
strong team player
• You have experience in document management
• You can work with ambitious timelines in our slim organization with a cross-
functional team
Y-mAbs Therapeutics A/S, Agern Allé 11, 2970 Hørsholm, Denmark, Tel: 45 7026 1414 www.ymabs.com
• You preferably have 1-2 years’ regulatory experience, maybe through student
work in Regulatory Affairs, and some knowledge of regulatory requirements
• You are result-oriented and committed to contributing to the overall success of
Y-mAbs
• Our company language is English, so your communication in both written and
spoken English is fluent
For more details about the job or our company, please contact VP of Regulatory Affairs,
Rikke Valentin Oxholm at 45 53 88 02 88 or Daniel Dam Doktor, RA LCM Lead at 45
53 88 01 65.
Your application must be submitted in English and will be treated confidentially.
You can apply for the position by sending an email to HR@ymabs.com. Please mark your
application with Job ID no. 1074.
Deadline for applications: 18 July 2022. We will initiate interviews in a rolling manner as
applications are received.
Y-mAbs Therapeutics A/S is located in Hørsholm, Denmark - a Danish affiliate of Y-mAbs
Therapeutics Inc.. Our mission is to discover, develop and deliver novel antibody
therapeutics for the treatment of both pediatric and adult cancer patients.
Please access the company website www.ymabs.com for more information regarding
the company and our development projects.
Y-mAbs Therapeutics A/S, Agern Allé 11, 2970 Hørsholm, Denmark, Tel: 45 7026 1414 www.ymabs.com Show more details...
via Miami, FL - Geebo
posted_at: 22 hours agoschedule_type: Full-timesalary: 20–28 an hour
Y-mAbs is a fast-paced biotech company with offices in New York, USA, and H rsholm, Denmark. Y-mAbs has commercialized, late-stage and innovative pipeline compounds that fill an unmet medical need for pediatric and adult cancer patients. Y-mAbs is looking for a dynamic team player to join our Medical Affairs team. If you are a scientist who stays at the forefront of the oncology field, enjoys... working with colleagues on challenging projects, and
Y-mAbs is a fast-paced biotech company with offices in New York, USA, and H rsholm, Denmark. Y-mAbs has commercialized, late-stage and innovative pipeline compounds that fill an unmet medical need for pediatric and adult cancer patients. Y-mAbs is looking for a dynamic team player to join our Medical Affairs team. If you are a scientist who stays at the forefront of the oncology field, enjoys... working with colleagues on challenging projects, and you are eager to bring innovative therapies to cancer patients, you are Y-mAbs scientist! The Senior Field Clinical Lead (Sr. FCL) role is dedicated to partner with Clinical development and Clinical Operations teams to identify and assist with global clinical trial sites to deliver on study performance and recruitment goals, as well as identifying and collaboratively resolving clinical trial site issues. Responsibilities include tumor specific global KOL / PI clinical trial engagement, support clinical operations team, CRO and clinical investigators in all aspects of study initiation and conduct. Sr. FCL will work closely with clinical operations, clinical development, medical affairs, and field medical organizations. Key
Responsibilities:
o Serve as the Lead for Global KOL/PI identification and management of external relationships o Identify Global Oncology Research Organizations and Oncology Cooperative Geoups (such as COG, Alliance, ACRIN, RTOG, SIOPEN, etc.) and build partnerships with Y-mAbs to support and enhance pipeline development. o Support Clinical Operations teams with identifying global clinical trial sites (adult and pediatric cancer types of clinical development interest), that can deliver on specific study recruitment goals. o Support clinical operations team in all aspects of study initiation, conduct and recruitment. o Utilize Medical and Clinical Development strategy and Drug Development Plan (DDP) to ensure future successful product launches when selecting sites. o Understand competing trials (global and site specific) and identify barriers to site recruitment (prior to study initiation and ongoing enrollment sites). o Keep constant communication with internal teams to ensure site delivers on expectations, adequately trained on the investigational product science and AE management. o Communicate with MSLs, that cover specific sites, and MA eldership (when needed) about specific site activities, delivering on recruitment and timelines o Provide scientific support, in collaboration with MA and field medical team, to internal and external stakeholders. o Train field medical on study protocols and update the team about any protocol amendments, when appropriate. o Assist Sci & Ops Lead with FM training materials development for specific tumors and products. o Provide input into FM external resources development and support Sci & Ops Lead o Assist Clinical Development and Clinical Operations team with slide and materials development for clinical trial sites. o Assist with congress preparation by working closely with clinical development, clinical operations, translational, medical affairs, and commercial groups to identify KOL / PI meeting opportunities based on business needs. Qualifications and Skills:
o Pharmaceutical or biotechnology industry experience and knowledge of country, regional and local regulations are required. o Scientific / clinical degree required. A Doctorate level degree (i.e. Pharm D, MD, PhD) preferred. o Working knowledge of clinical trial conduct is preferred. o Experience as Field Medical Scientist is preferred. o Must be a team player with a positive attitude willing to work in an environment where individual initiative and accountability to the team are required. o Individual must be capable of working independently with minimal supervision, taking initiatives, as well as being part of an integrated team, and have flexibility to react to changing priorities. o Demonstrate the ability to organize and prioritize assigned workload and to employ efficient time management strategies when performing assigned tasks and responsibilities. o Strong written and verbal communication skills o Results and solutions oriented o Ability to travel 70% within US and internationally is required
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications Show more details...
Responsibilities:
o Serve as the Lead for Global KOL/PI identification and management of external relationships o Identify Global Oncology Research Organizations and Oncology Cooperative Geoups (such as COG, Alliance, ACRIN, RTOG, SIOPEN, etc.) and build partnerships with Y-mAbs to support and enhance pipeline development. o Support Clinical Operations teams with identifying global clinical trial sites (adult and pediatric cancer types of clinical development interest), that can deliver on specific study recruitment goals. o Support clinical operations team in all aspects of study initiation, conduct and recruitment. o Utilize Medical and Clinical Development strategy and Drug Development Plan (DDP) to ensure future successful product launches when selecting sites. o Understand competing trials (global and site specific) and identify barriers to site recruitment (prior to study initiation and ongoing enrollment sites). o Keep constant communication with internal teams to ensure site delivers on expectations, adequately trained on the investigational product science and AE management. o Communicate with MSLs, that cover specific sites, and MA eldership (when needed) about specific site activities, delivering on recruitment and timelines o Provide scientific support, in collaboration with MA and field medical team, to internal and external stakeholders. o Train field medical on study protocols and update the team about any protocol amendments, when appropriate. o Assist Sci & Ops Lead with FM training materials development for specific tumors and products. o Provide input into FM external resources development and support Sci & Ops Lead o Assist Clinical Development and Clinical Operations team with slide and materials development for clinical trial sites. o Assist with congress preparation by working closely with clinical development, clinical operations, translational, medical affairs, and commercial groups to identify KOL / PI meeting opportunities based on business needs. Qualifications and Skills:
o Pharmaceutical or biotechnology industry experience and knowledge of country, regional and local regulations are required. o Scientific / clinical degree required. A Doctorate level degree (i.e. Pharm D, MD, PhD) preferred. o Working knowledge of clinical trial conduct is preferred. o Experience as Field Medical Scientist is preferred. o Must be a team player with a positive attitude willing to work in an environment where individual initiative and accountability to the team are required. o Individual must be capable of working independently with minimal supervision, taking initiatives, as well as being part of an integrated team, and have flexibility to react to changing priorities. o Demonstrate the ability to organize and prioritize assigned workload and to employ efficient time management strategies when performing assigned tasks and responsibilities. o Strong written and verbal communication skills o Results and solutions oriented o Ability to travel 70% within US and internationally is required
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications Show more details...
via San Jose, CA - Geebo
posted_at: 5 days agoschedule_type: Full-timesalary: 20–28 an hour
Y-mAbs Therapeutics is a mid-stage biotech company with a growing pipeline in cancer therapeutics, including one FDA-approved product (Naxitamab). Employees are based both in the US and Denmark, with a R&D Laboratory established in Nutley, NJ and only a short distance from New York city. Primary Responsibilities This position will join a team of 5 scientists to help push forward new cancer... therapeutics from basic concepts to IND-ready pharmaceuticals.
Y-mAbs Therapeutics is a mid-stage biotech company with a growing pipeline in cancer therapeutics, including one FDA-approved product (Naxitamab). Employees are based both in the US and Denmark, with a R&D Laboratory established in Nutley, NJ and only a short distance from New York city. Primary Responsibilities This position will join a team of 5 scientists to help push forward new cancer... therapeutics from basic concepts to IND-ready pharmaceuticals. The candidate will be responsible for performing and analyzing biochemical and biophysical assays such as mass spec and capillary gel electrophoresis that characterize new candidate molecules ahead of in vitro and in vivo functional assays. In addition to hands on work, this position will also interface with CROs that can provide support for additional or specific assays not available on site at the Y-mAbs R&D laboratory. The role will also work closely with personnel in charge of protein expression and protein purification, providing experience and insight into ongoing work and unanticipated bottle necks. The ideal candidate will have substantial experience in characterizing novel proteins (Mass Spec, CZE, cIEF, etc), protein expression systems (including Expi293, ExpiCho, and CHO-3E7), as well as working with CROs to generate data reports. This role will include hands on work with individual assays, in depth data analysis, designing new molecules and helping fix or troubleshoot problematic proteins. Required Qualifications o PhD in biochemistry, chemistry, protein engineering or similar o 3
years post-doc experience and/or 2
years industry experience o Experience in protein expression and purification methods o Experience with protein biophysical characterization including cIEF, CE-SDS, SEC-HPLC, SDSPAGE, Mass Spec, buffer formulation o Demonstrated ability to work effective in cross function teams, meet deadlines and prioritize multiple projects o Experience working in a self-driven, performance/results oriented, fast paced matrix environment o Experience in screening proteins and identifying problematic candidates or sequence motifs o Demonstrated ability to clearly communicate complex ideas and datasets in presentations and formal reports Interested? You can apply for the position by sending an email to hr@ymabs.com as soon as possibel and please mark your applications with position ID number:
2035. We will initiate interviews in a rolling manner as applications are received. Please note that applications must be submitted in English and will be treated confidentially
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications Show more details...
years post-doc experience and/or 2
years industry experience o Experience in protein expression and purification methods o Experience with protein biophysical characterization including cIEF, CE-SDS, SEC-HPLC, SDSPAGE, Mass Spec, buffer formulation o Demonstrated ability to work effective in cross function teams, meet deadlines and prioritize multiple projects o Experience working in a self-driven, performance/results oriented, fast paced matrix environment o Experience in screening proteins and identifying problematic candidates or sequence motifs o Demonstrated ability to clearly communicate complex ideas and datasets in presentations and formal reports Interested? You can apply for the position by sending an email to hr@ymabs.com as soon as possibel and please mark your applications with position ID number:
2035. We will initiate interviews in a rolling manner as applications are received. Please note that applications must be submitted in English and will be treated confidentially
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications Show more details...
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