TOPIC: Data Types

InitiativeCategory
https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-37f9d61e4eba471b121cf447dc426189-ff-BioNJ-Logo_Outlines.pngTrial Sponsorhttps://www.bionjtalentnetwork.org/My Articlelasdfkj asd f asd fa sdf asdj f;laskdjfo;aisfuaiew ;al a d al sdf a sdf a df a sdf as df as kja;sdlkfja;k esf;alks ;alksdjf ljad;lfkj a;lkdsj flaksdjf;l akjd f;lkajdf;lkajs flkadj. alkj;alksjd ;lkajsd;lkja ;lkja; lkj ;lakjsd;lfk ja;d j;alkjf;lkajs ;ob Description Summary: ​The Research Associate I, Biology is responsible for performing scientific experiments that contribute to research and drug discovery activities at PTC. This position assists in the conduct of early-stage research, the goal of which is the identification of New Chemical Entities (NCEs), as well as the advancement of research programs from the identification of screening hits to advanced lead optimization. The incumbent is also responsible for communicating experimental results to his/her supervisor and the project team.

The Research Associate I, Biology supports adherence to all regulatory requirements and company Standard Operating Procedures (SOPs) including as appropriate. Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

  • Under supervision, executes experiments as directed by the supervisor and communicates results as part of multi-disciplinary team(s).

  • Applies relevant scientific principles and techniques to research problems.

  • Maintains detailed laboratory notebooks.

  • Maintains broad knowledge of state-of-the-art principles and techniques and may contribute to the identification of new project areas or technologies.

  • Presents findings internally and contributes to the publication of the work of the project team in well-established and peer reviewed journals, subject to internal scientific and legal approval.

  • May provide technical and scientific input to the project team.

  • Complies with all safety requirements.

  • Contributes to general lab operations such as:

    • Equipment maintenance.

    • Identification of capital equipment needs

    • Maintenance of clean and uncluttered work areas

    • Maintain inventory and ordering lab supplies as needed.

Specific duties may also include, but may not be limited to, the following:

  • Provides support for high throughput screening including the design of primary assays, the goal of which is the identification of additional hits and new chemical scaffolds.

  • Provides support for lead optimization by screening compounds and/or supporting structure activity relationship (SAR) studies involving the characterization of the biological activity of compounds in various assays. Profiles selected compounds in additional cells/assays.

  • Provides support for in vivo and in vitro studies as required.

  • Assists in the development of biologically relevant alternatives to preclinical animal models.

  • Conducts mechanism of drug activity studies utilizing biophysical and biochemical methods.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

  • Bachelor’s degree in a scientific discipline, preferably Biology, Biochemistry or Chemical Biology with a minimum of 0-1 years’ experience.

* Special knowledge or skills needed and/or licenses or certificates required.

  • Demonstrates technical proficiency, scientific creativity, and the ability to collaborate with others on cross functional teams in a fast-paced, matrixed, environment consisting of internal and external team members.

  • Possesses knowledge of scientific principles and concepts and keeps current with relevant scientific literature.

  • Proficiency with Microsoft Office- preferably MS Excel and MS PowerPoint.

  • Effective verbal and written communication and skills.

  • Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines.

  • Effective planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

  • Enzymatic experience – moderate to high-throughput assays characterization of enzyme activity. Preference for experience with automated fluid handling (e.g. Tecan Fluent).

  • Knowledge of and ability to use standard molecular and cell biology techniques.

  • Experience with biophysical methods for protein-ligand binding including, but not limited to, SPR, BLI, DSF, and NMR.

Expected Base Salary Range

$58K to $70K

The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-7fa8f5711824755a925aa125c780c8b4-ff-logo.pngTrial Sponsorhttps://www.bionjtalentnetwork.org/Dan's 2nd InitiativeDan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd Initiative Dan's 2nd InitiaJob Description Summary: The Senior Scientist, GxP Bioanalytical, Clinical Pharmacology provides quantitative bioanalyses of biological samples in support of the clinical and/or preclinical development of small molecule products.

This position uses analytical techniques including, but not limited to, Liquid Chromatography-Mass Spectroscopy (LC-MS) to develop and validate bioanalytical methods for small molecule programs.

The selected candidate coordinates and executes in-house bioanalytical method development and validation to support clinical / preclinical projects for small molecules using LC-MS/MS. The Sr. Scientist also performs/coordinates sample analysis and interprets data and provides timely support to the broader development program(s) including regulatory submissions. The Sr. Scientist may also monitor and coordinate bioanalytical activities at Contract Research Organizations (CROs) in support of small molecule clinical and/or preclinical development. The analyses may include those governed by FDA or other global health authority regulations.

The incumbent works cross-functionally with internal departments and external resources on bioanalytical method development, sample analysis and related activities.

The Senior Scientist, GxP Bioanalytical, Clinical Pharmacology adheres to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

  • Coordinates and executes in-house bioanalytical method development and validation activities to support bioanalysis for small molecules bioanalysis for clinical / preclinical projects using LC-MS/MS.

  • May also monitor and coordinate bioanalytical activities at Contract Research Organizations (CROs) in support of small molecule clinical and/or preclinical development.

  • Develops and implements Standard Operating Procedures (SOPs) for GxP bioanalytical workflow(s).

  • Collaborates with clinical / preclinical drug development program teams. Defines, coordinates, manages and oversees the bioanalytical project timeline.

  • Responsible for the scientific quality of the bioanalytical projects in support of clinical and/or preclinical development.

  • Represents the bioanalysis function on the development program teams and presents results, timelines, etc. at project team meetings.

  • Performs other tasks and assignments as needed and specified by management.

  • Complies with PTC’s laboratory safety guidelines and completes trainings in a timely manner.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

  • Master’s degree in chemistry, biology, biochemistry, pharmaceutical science, pharmacology, or other related scientific discipline and a minimum of 8 years of relevant analytical development experience in pharmaceutical, biotechnology, or regulated bioanalytical CRO or other related environment OR a PhD in chemistry, biology, biochemistry, pharmaceutical science, pharmacology, or other related scientific discipline and a minimum of 5 years of analytical development experience in a pharmaceutical, biotechnology or bioanalytical CRO or other related environment OR equivalent education and / or experience.

* Special knowledge or skills needed and/or licenses or certificates required.

  • Progressively responsible experience in bioanalytical method development, validation and regulated bioanalysis of clinical / preclinical samples (plasma, urine, etc.) using LC/MS/MS techniques.

  • Hands on experience with bioanalytical method development and validation in a regulated environment for small molecules.

  • Experience managing multiple projects with competing priorities.

  • Demonstrated experience writing study reports and regulatory documents.

  • Ability to influence without direct authority.

  • Proficiency with Microsoft Office.

  • Excellent verbal and written communication and skills.

  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

  • Experience writing analytical reports.

  • Experience working within or with a Contract Research Organization (CRO).

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

NamedScience’s Top Employer in 2021 and 2022

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT.

Overview

Reporting to the Senior Director of Clinical Quality Assurance, the AD/Director of Clinical Quality Assurance serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the clinical development team, and collaborates on other related activities performed by Clinical Operations and Medical Departments The incumbent will provide support and promote collaboration internally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.

Depending on experience, this position can be filled at Director or Associate Director level.

This is primarily a San Diego based position. Out of state candidates will be asked to make trips to the office as business needs warrant.

This is a non-supervisory position (possible future supervisory role, 1-2 people)

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

  • Establish and maintain a risk-based and scientific-based quality system to support Good Clinical Practice.
  • Oversee regulatory agency inspections and vendor audits.
  • Ability to ensure that a strategic audit plan is developed, designed and implemented, and that the activities are conducted, and reports written according to SOPs and regulations.
  • Oversee GCP activities (including internal or external audit observations and development of adverse trends) to ensure patient safety and data integrity.
  • Supports strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.
  • Supports the evaluation and acceptability of vendors for potential use and provides direction, guidance and strategy for company Quality Assurance.
  • Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice.
  • Provide support and coaching to other staff members to develop additional quality and auditing resources.
  • Manage quality documentation in Veeva. (SOPs, CAPAs, Deviations, etc.)
Qualifications

About You:

  • Minimum BS degree in Chemistry or related life sciences discipline required with minimum 8-12 years of experience.
  • Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
  • Requires solid experience supporting Phases I-IV (particularly Phase III); experience with Regulatory submissions and/or approval.
  • Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
  • Experience with combination products a plus.
  • Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.
  • Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.
  • Must be able to foster a collaborative environment, adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
  • Must be able to prioritize work effectively to meet timelines.
  • Excellent written/oral communications skills and presentation skills.
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
  • Demonstrated ability to work independently, flexibility and the ability to manage variable workloads.
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Travel Requirements

Up to 15% flexible self-directed travel, both domestic and/or international

Salary RangeInsmed takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $165,000.00 to $231,667.00Compensation & Benefits

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

  • Flexible approach to where and how we work
  • Competitive compensation package including bonus.
  • Stock options and RSU awards
  • Employee stock purchase plan
  • 401(k) plan withcompanymatch
  • Professional Judgment Vacation Policy
  • 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).

ADDITIONAL U.S. BENEFITS:

  • Medical, dental, and vision plans
  • Company-provided short- and long-term disability plans
  • Company-provided life insurance
  • Unique offerings of pet, legal, and supplemental life insurance
  • Flexible spending accounts for medical and dependent care
  • Accident and Hospital Indemnity plans
  • Supplemental AD&D
  • Employee Assistance Program (EAP)
  • Mental Health on-line digital resource
  • On-site, no-cost fitness center at our U.S. headquarters
  • Paid time off to volunteer
Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep all submissions on file for six months.

https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-66ca8e6dc50805dd6981549ace644d6a-ff-logo.pngTrial Sponsorhttps://www.bionjtalentnetwork.org/Tuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestTuesday Feb 7th Initiative 02 TestCompany Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

NamedScience’s Top Employer in 2021 and 2022

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT.

Overview

This position is primarily responsible for providing strategic oversight to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (e.g. SDLC, IT Change Control) per associated regulatory and security requirements. Position will oversee and provide QA support for optimizing, troubleshooting, and maintaining key global GMP quality systems including Veeva Quality Docs (electronic document management system), Veeva QMS (electronic Quality Management System), and additional GxP systems for Gene Therapy manufacturing, quality control, warehouse, and clinical programs. The position will serve as the QA lead for Computer Software Validation lifecycle documents, site IT Change Control facilitation and QA review of CSV documents.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Manage, maintain, and continuously improve Insmed’s global Electronic Document Management System (EDMS), Quality Management System (QMS), additional Quality owned software platforms (labeling, metrics, etc.) and electronic GxP record archiving.• Serve as QA electronic system validation expert.Provide oversight and QA support on all GxP software used by the Gene Therapy business in accordance with applicable regulations, guidelines, policies and procedures. Types of systems may include: CTMS, LIMS, CMMS, ICN, ERP (inventory management), laboratory equipment software, building management, environmental monitoring, etc.• Train, support and advise end users on EDMS and QMS system requirements and workflows. Develop training modules for EDMS and QMS.• Liaising with corporate QA, eead EDMS and QMS cross functional subject matter expert forum for continuous improvement.• Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.

• Responsible for the local processes related to QMS, IT Change Control, Computerized System Validation, Data Integrity for electronic systems, and monitoring/auditing of audit trails.• Provide support during regulatory inspections and internal audits.• Experience with Veeva systems is preferred.• Experience implementing, validating, maintaining, and integrating electronic document and Quality Management in an FDA or equivalent regulated settings.• Role-related knowledge: Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.• Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development, including delivery of multiple projects of various complexities• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department• Additional duties as may be assigned from time to time

Qualifications

• Education – BS Degree required or preferred• A minimum of 5 years of relevant Quality Assurance experience required. An advanced degree (MS) and a minimum of 3 years relevant experience will also be considered• Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc..• Preferred experience in Data Integrity, 21 CFR Part 11, GAMP, CDLC (Agile or Waterfall)• Must have excellent communication skills (verbal and written).• Demonstrate ability to manage projects and variable workloads.• Highly organized with a strong attention to details, clarity, accuracy, and conciseness. • Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies

Travel Requirements

Up to 10% travel.

Salary RangeInsmed takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $135,000.00 to $188,333.00Compensation & Benefits

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

  • Flexible approach to where and how we work
  • Competitive compensation package including bonus.
  • Stock options and RSU awards
  • Employee stock purchase plan
  • 401(k) plan withcompanymatch
  • Professional Judgment Vacation Policy
  • 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).

ADDITIONAL U.S. BENEFITS:

  • Medical, dental, and vision plans
  • Company-provided short- and long-term disability plans
  • Company-provided life insurance
  • Unique offerings of pet, legal, and supplemental life insurance
  • Flexible spending accounts for medical and dependent care
  • Accident and Hospital Indemnity plans
  • Supplemental AD&D
  • Employee Assistance Program (EAP)
  • Mental Health on-line digital resource
  • On-site, no-cost fitness center at our U.S. headquarters
  • Paid time off to volunteer
Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep all submissions on file for six months.

https://mmt.d8c.myftpupload.com/wp-content/uploads/fluentform/ff-66ca8e6dc50805dd6981549ace644d6a-ff-logo.pngScreening Processeshttps://www.bionjtalentnetwork.org/Tuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTuesday Feb 7th Initiative TestTu
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