דרושים Sr Manager Biologics Cmc Writer ב-Incyte ב-United States, Wilmington

Job Summary

The clinical scientist will

Key Responsibilities

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.

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Job Summary (Primary function)
The Sr. Biologics CMC (Chemistry, Manufacturing, and Controls) Writer will be primarily responsible for authoring CMC sections of global regulatory submissions including BLA, IND, IMPD, MAA as well as working with other technical documents (e.g.. Redlining/SOC reports). The position will manage work independently with members of the Biologics Pharmaceutical Development group as well as other functional areas within the organization, including external collaborators, to complete the full package ready for submission.

Essential Functions of the Job (Key responsibilities)

• Contribute to the phase appropriate development strategy for the Biologics portfolio.
• Write and edit CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide. Experience with authoring Module 3 CTD sections for IND and BLA is highly desirable.
• Collaborate with subject matter experts to write and edit other manufacturing related controlled technical documents using a uniform style and language for regulatory compliance.
• Coordinate authoring and review activities with the functional areas within Global Biopharmaceutical Development and Quality Assurance to reach alignment and to meet deadlines for Regulatory Submissions.
• Work closely with Regulatory Affairs to establish priorities and ensure successful completion of regulatory submissions to Regulatory Operations.

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

• Degree (such as BS/MS/PhD) in Engineering or Biological Sciences or equivalent experience and in the biotech related industry.
• Several years of experience in Biologics technical writing as a SME in Analytical, Formulation, or Process Sciences, in authoring CMC sections of global regulatory filings.
• Technical knowledge of and experience in monoclonal antibody development is a plus.
• Experience with working collaboratively with other departments such as technical teams, Quality Assurance and Regulatory Affairs.
• Proven track record on regulatory submissions of biological products.
• Demonstrate competency in clear and concise technical writing ability.
• Must be well organized, flexible, with excellent cross-functional communication skills that encourages inclusion and welcomes diversity of thought among stakeholders.

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.

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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)

·Support the Sample Logistics needs of a diverse group of scientists within the Discovery organization through timely order fulfilment and sample delivery. Develop and integrate CM workflows to support new scientific needs, with a preference for simplifying and streamlining CM delivery processes

·Support Mosaic integration, including transfer of sample management protocols (Solubilization, Titration, Cherry picking), plate definitions and plate maps to Mosaic environment, with a goal of reducing complexity and standardization of processes and deliverables. Serve as Mosaic SME

·Facilitate Sample Management support for large molecule discovery, including normalization, storage and Titration. Facilitate large molecule order fulfilment on new and existing hardware in Mosaic environment

·Acts as custodian of compound management laboratory instruments. Responsible for all instrument service-related tasks.

·Assist with all other Sample management related tasks including HTS library management and Assay plate stamping on Echo automated platforms

·Help to develop new and streamlined workflows to CM to support existing and future order fulfilment

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

·Extensive years of relevant experience in sample management, with a focus on skills and competencies rather than specific years.

·High competency with Mosaic order fulfilment process, template creation, and user training.

·Working knowledge of and Hamilton liquid handlers and tube storage systems

·Degree in chemistry, biochemistry, or related fields, or equivalent experience.

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.

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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 Research Scientist, Toxicology, provides toxicology support to assigned program(s), with functions in necropsy, histology, and clinical pathology.

Essential Functions of the Job (Key responsibilities)

• Performs necropsy of mice and rats, oversees necropsy setup, cutting, and trimming. Assist in managing the necropsy facility. Assists in training team members to perform mice and rat necropsies. Has a working knowledge of the software system (Pathology Data Systems, PDS) used for data collection of macroscopic findings and organ weights. Proficient in using the software to set up studies for data collection.
• Perform Clinical Pathology setup and instrument maintenance according to study requirements. Collect and analyze hematology and clinical chemistry samples using current in-house equipment, ensuring accessibility for all team members. Demonstrate knowledge of analyte ranges, data interpretation, control data, and calibration data. Utilize software (PDS) for the collection and quality control of clinical pathology data, ensuring inclusivity and accessibility in data handling.
• Preparation of histology slides from tissues from both large animal studies (e.g., dog, monkey) in collaboration with CRO's and small animals (e.g., rat, mouse) in-house studies, including trimming, processing, embedding, sectioning, and H&E staining. Assist with quality assessment of the pathology slides. Working knowledge of maintenance of the instrumentation to perform these functions.
• Preparation of immunohistochemically stained tissues sections and organic stained tissue sections on a per study basis.
• Archive gross tissues, tissue cassettes, and slides. This includes the receipt, reading and return of slides from GLP and non-GLP peer review studies.
• Collaborate and support other groups in the method development of animal models. Working knowledge of cell culture preparation, alternative media preparation, and whole blood assays is preferred, but not required.
• Assist in quality assurance of data and reports generated by the pathology group.

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

• Degree in Biology/Medical Technology or a related field, or equivalent education and experience.
• Significant experience in a relevant scientific discipline, with a focus on skills and knowledge over years of experience.
• ASCP HT or other medical technology certification preferred but not 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 position will be mainly responsible for performing high resolution LC-MS analysis to characterize novel therapeutic monoclonal antibodies including bispecifics which are used for clinical studies and commercial launch. This is a hand-on position and requires solid scientific knowledge of LCMS for protein characterization and working experience with different high-resolution mass spectrometry platforms (Q-Tof and/or Orbitrap). Strong interpersonal and communication skills are required.

Essential Functions of the Job (Key responsibilities)

• Design and perform experiments for therapeutic proteins using high resolution LC-MS (Qtof and/or Orbitrap) including intact/reduced intact protein mass spec, reduced and non-reduced peptide mapping for characterizing protein primary structure, protein post-translational modifications, sequence variant analysis, and disulfide mapping.
• Record experiments in electronic laboratory notebook to ensure complying with our internal quality policy. Operate and maintain bioanalytical instrumentation in compliance with all safety rules and procedures.
• Interpret LCMS data and generate summary reports to support cell line development, process and formulation development, and comparability studies. Write detail technical reports of protein characterization and elucidation to support novel therapeutic monoclonal antibodies research and development.
• Monitor lab instrument performance weekly, track and order lab supplies when needed.
• Present data summaries and study conclusions at internal scientific meetings.

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

• Expertise with protein mass spec especially mAb PTM characterization by LCMS is a must.
• Ph.D. in chemistry or related fields some relevant experience; Masters’ degree with 3-5 years relevant experience; or Bachelors’ degree in Biopharmaceuticals with >6 years’ relevant experience.
• Working experience with Qtof instruments and/or Thermo Orbitrap is a plus.
• Critical thinking, strong written and verbal communication and organization skills are required.
• Willingness to work independently while collaborating with different functional groups is essential.
• Self-motivated with desire to learn new skills and highly organized with ability to work on multiple projects simultaneously.

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)

Reports to Assoc. Vice President, Contracts and Governance; regarding the Contract Lifecycle Management (CLM) system. This position is responsible for projects that help drive efficiency and improve Legal department processes. May work with internal and external clients. Ensures that goals are accomplished and in line with objectives and against timelines. Helps to monitor activities of IT ensuring quality and integrity in relation to CLM. Comfortable making decisions, as appropriate, and knows when to escalate. Willingness to grow and take on additional responsibilities as it relates to Legal technologies or systems.

Essential Functions of the Job (Key responsibilities)

·Governance and Maintenance of all Templates and Clause Library configured into CLM

·Govern and maintain contract templates

·Collaborate with Legal Counsel and other relevant functional area stakeholders, as it relates to contract terms and templates

·Identify opportunities for and/or establish, vet and document fallback language and options with guidance/drafting notes

·Build and maintain clause library based on risks, standards, and fallbacks developed

·Establishment and Maintenance of a Document Repository

Identify, implement and maintain a document repository by working with Legal and IT

Governance for 3rd Party Risk Accountability & Engagement Pre-contract and Contracting Playbook(s)

Assist with development of and, ongoing management and governance of pre-contracting and contracting processes.

Facilitate and organize meetings among global stakeholders.

Assist in the development, maintenance, delivery and implementation of training related to pre-contracting and CLM processes and systems along with IT, Global Strategic Sourcing, and other relevant stakeholders.

·Contract Resource Center of Excellence

Build and/or provide guidance to contract negotiators located in Legal, Global Strategic Sourcing, and certain functional areas including but not limited to Development Operations and US Medical Affairs.

·Records Retention

Work with Legal and Compliance to help refine, develop, document, govern, maintain and implement records retention schedule, in relation to CLM

·Relationships

·CLM Maintenance

Assist with contract system configuration by working with IT and consultants as applicable; learn and develop CLM configuration skills

Perform testing in CLM, as may be required

Drive or assist with communications related to system changes or updates

Manage day-to-day overall database administration

·Training

For all assigned duties, assist with the development and delivery of training materials for staff globally

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

·Bachelor’s degree or equivalent relevant experience

·Significant relevant experience (typically 8-10+ years), or equivalent combination of education and experience

·Legal background, J.D. or Paralegal Certification preferred, or equivalent relevant experience

·Experience in the pharmaceutical industry or a related field preferred

·Knowledge of, or willingness to learn, SOX requirements, controls, and processes

·Familiarity with DocuSign, or willingness to learn

·Familiarity with Conga (Salesforce platform) helpful but not required

·Familiarity with Agiloft CLM and AI functionality helpful but not required

·Familiarity with ZIPHq helpful but not required

·Ability to draft legal language

·Ability to navigate CLMs or other Compliance/Operational Technologies

·Demonstrate interpersonal, communication and organizational skills

·Ability to effectively communicate and comfortable working across functional areas and with a wide range of audiences, including from individual contributor and executives

·Ability to take direction and work independently

·Ability to design or test new processes, capabilities, and technologies

·Ability to suggest ideas and present; ability to analyze and document current processes and establish new processes

·Ability to design or test new processes, capabilities, and technologies

·Self-motivated, able to work collaboratively, organized, and detail-oriented

·Demonstrates dependable time management skills and ability to make decisions

·Positive and constructive attitude

·Ability to manage multiple projects and tasks

·Ability to adapt to new challenges and changes in direction

·Ability to learn, follow and help further define or establish processes

·Ability to work with a variety of variables

·Ability to interpret a variety of instructions furnished in written, oral, hands-on, or diagram form

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 .

Duties and Responsibilities

• Deliver therapeutic information on products in line with marketing strategy
• Promote INCYTE IAI Dermatology product to prescribing Dermatologist specialists in compliance within compliance and legal requirements and according to the marketing and sales strategies defined by the product line
• Create formal networks with key decision makers within the assigned territory and with important local players; use these contacts appropriately to develop district business within compliance and legal requirements and company policy
• Market surveillance – gain and share customer insights
• Perform local marketing, sales analyses and gain patient flow insights
• Organize and conduct regional promotional meetings for physicians and other stakeholders
• Management of professional relations with Opinion leaders
• Develop and execute customer and account business plans, within designated key accounts, to ensure that all appropriate patients have access to INCYTE Pharmaceuticals medicines
• Understand and map the local and regional funding, clinical and access decision processes and identify all key stakeholders
• Ensure a favourable local access environment to maximise the potential for sales, and to drive sales growth to realise this potential
• Documentation and reporting of daily activities, routine administration, finances etc
• Participation at congresses, meetings and physician trainings
• Excellent team player with proven ability to work cross-functionally and coordinate effectively with key internal stakeholders
• Curiosity and lifelong learning – Constantly update commercial knowledge and disruptive strategies.
• Creative thinking – Find innovative solutions for barriers and challenges.
• Manage and own personal development plan
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines

Requirements

• Life Sciences Degree or equivalent professional qualification
• More than 5 years of experience in promoting specialist pharmaceutical products – preferably in Dermatologist
• Demonstrated track record of Specialist sales
• Experience or understanding of Market Access and the NHS environment is a plus
• Good team player
• Very strong communication and presentation skills
• Professional appearance
• Self-motivated entrepreneurial mindset
• Good IT-skills

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 .