-
Insmed Bridgewater, NJ, United StatesCompany 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 ...
-
Insmed Bridgewater, NJ, United StatesGuided 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. Named Science's Top Employer in 2021 ...
-
Specialist, Qc Bioanalytical
6 days ago
Ferring Pharmaceuticals, Inc. Parsippany, United StatesJob Description: · As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us ...
-
Bristol-Myers Squibb Princeton, United StatesAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues con ...
-
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our wo ...
-
Daiichi Sankyo Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ou ...
-
Daiichi Sankyo Inc. Basking Ridge, United States**Join a Legacy of Innovation 110 Years and Counting** · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class ...
-
Operations Project Manager
3 weeks ago
The Fountain Group Basking Ridge, United StatesOperations Project Manager - Clinical Trials · 6 month Contract - · potential to be extended · Pay : $57 - 63/hour · Description: · Job Schedule: · Candidate must be local and able to come into the Basking Ridge, NJ office twice a week. · Job Summary: · The position of Manag ...
-
Daiichi Sankyo Basking Ridge, United States Full timeJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...
-
Research Scientist
6 days ago
Syneos Health, Inc Princeton, United States· Research Scientist · This position requires experience in bioanalytical research, preferably working for a CRO or Research lab/company. Small molecule experience is preferred, along with method development. This role is an ON SITE role in PRINCETON, NEW JERSEY. · Syneos Health ...
-
Mass Spectrometry Lab Manager
2 days ago
Scientech Laboratories, LLC South Plainfield, United StatesSCIENTECH LABORATORIES – MASS SPECTROMETRY LAB MANAGER · The Mass Spectrometry (MS) Lab Manager is responsible for establishing standard operating procedures (SOPs), developing methods and efficient work processes, managing lab workflow, personnel, and deliverables in a cGMP anal ...
-
Principal Scientist
2 weeks ago
Bristol-Myers Squibb Princeton, NJ, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
Manager, Clinical Pharmacology
3 weeks ago
Adlai Nortye Ltd East Brunswick, United StatesJob Description · Job Description · Company Overview: · We are a dynamic and innovative small biotechnology company dedicated to advancing oncology research through cutting-edge translational science. Our mission is to translate scientific discoveries into tangible therapeutic ...
-
Bristol-Myers Squibb Company Princeton, United StatesAssociate Director, EDT Documentation Lead, Early Development page is loaded · Associate Director, EDT Documentation Lead, Early Development · Apply · locations · Princeton - NJ - US · time type · Full time · posted on · Posted 30+ Days Ago · job requisition id · R · A ...
-
Bristol-Myers Squibb Company Princeton, United StatesAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues con ...
-
Associate Director, Bioanalysis, Genomics
1 week ago
Aztec Princeton, United StatesOtsuka is looking for a naturally curious, self-motivated individual to join the Bioanalytical, Genomics, and Biomarker Research team. Innovative projects that focus on bringing solutions to clinical programs, such as -omics analysis for the elucidation of mechanism of action and ...
-
Bristol-Myers Squibb Company Princeton, United StatesAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues con ...
-
Research Scientist
4 days ago
Syneos Health - USA Princeton, United States Full time· Research Scientist · This position requires experience in bioanalytical research, preferably working for a CRO or Research lab/company. Small molecule experience is preferred, along with method development. This role is an ON SITE role in PRINCETON, NEW JERSEY. · Syneos Healt ...
-
Director Development DMPK
2 weeks ago
Knewin Princeton, United StatesWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Director Development DMPK
3 weeks ago
The Judge Group Princeton, United StatesWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
Associate Director Translational Bioanalytical Sciences - Bridgewater, NJ, United States - Insmed
Description
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases.
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
Named Science's Top Employer in 2021, 2022, and 2023Insmed is dedicated to creating a collaborative environment where our team can thrive.
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 WorkWe believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row.We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, and Best Workplaces for Millennials lists.
Overview
Within the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large molecule quantitative assay development of biological samples.
The successful candidate is expected to establish, monitor validated bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical, nonclinical and biomarkers studies.
This translational role resides within the Clinical Development organization, works closely with colleagues in other functions, including strategic interactions with multiple Research groups.
The role will provide scientific and strategic guidance to global project teams and will oversee the internal and CRO resources as they relate to TBS.
Responsibilities
Lead projects, provide oversight of outsourced GxP bioanalytical validations and sample analysis from early to late development for pharmacokinetic and biomarkers studies.
Assure bioanalytical tasks are executed to high scientific standards, with quality, and within agreed timelines. This entails overseeing work by internal facilities or external vendors, within a matrix-structured environment. No bench activities are expected from this role.
Provide technical expertise on sample preparation, chromatography, mass spectrometric instrumentation, stability, and other method related issues.
Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety, contract research organizations etc.) to build and to execute the bioanalytical strategy specific to clinical development programs.
Participate in clinical study design and documentation (lab manual, protocol, report, SAP)Participate in preclinical study design and documentation as needed.
Contribute to regulatory document writing (e.g.IB, IND, Integrated Summary of Immunogenicity).Engage in scientific advice meetings with regulatory authorities (FDA, EMA, PMDA)Manage customized bioanalytical assays via network of external service providers in advance of and during clinical development.
Participate in vendor governance.Identify, evaluate, and manage bioanalytical vendors, partnering with the Procurement function.
Qualifications:
PhD or MS in Analytical Chemistry, Chemistry, Biochemistry, or another relevant field.
Minimum of 8+ years' post-doctoral experience or equivalent in the pharmaceutical, CRO or related industry within bioanalytical area across various modalities.
Demonstrated method development and validation experience with various platforms with deep expertise in LC-MS/MS regulated quantification.Advanced knowledge of various mass spectrometry platforms, ionization methods, quantitative analysis techniques for small molecules, hybrid or biological molecules (eg.
proteins, peptides, oligonucleotides, etc.).Demonstrated expertise in best practices recommended by FDA, EMA, CLSI to conduct development, qualification and validation of assays (e.g.
M10 Bioanalytical Method Validation).Familiarity and experience in establishing clinical biomarker analyses for clinical trials.Strong understanding and experience current GxP or CAP/CLIA/ISO standardsExcellent communication skills (verbal and written) and presentation skills are required.
Excellent interpersonal skills and the ability to function in a highly matrixed team environment.
Knowledge of LIMS systems such as Watson or similar is considered a bonus.
Travel Requirements
up to 10%
Salary Range
Insmed 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.
Compensation & 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, regionally basedCompetitive compensation package including bonus Stock options and RSU awardsEmployee Stock Purchase Plan (ESPP)Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U
S BENEFITS:
401(k) plan with company matchMedical, dental, and vision plansCompany-provided Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance Program (EAP)Mental Health on-line digital resourceWell-being reimbursementPaid leave benefits for new parentsPaid time off to volunteerOn-site, no-cost fitness center at our U.S.
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.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.Job SummaryExternal ID:
R1189Job Function:
Clinical DevelopmentRemote: No
Salary Range:
$140,000.00 to $200,000.00 a yearPosition Location (WD) : Location: US-USA-NJ-Bridgewater
