Associate Director Translational Bioanalytical Sciences TBS
Associate Director Translational Bioanalytical Sciences TBS
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1 Vacancy
Job Description
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 patientsfirst 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
Consistently Ranked Sciences Top Employer
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. Thats why weve been named the No. 1 company to work for in the biopharma industry in Sciences Top Employers survey for four years in a row.
A Certified Great Place to Work
We believe our company is truly special and our employees agree. In July 2024 we became Great Place to Workcertified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma Best Workplaces in New York PEOPLE Companies That Care Best Workplaces for Women Best Workplaces for Millennials and Best Medium Workplaces lists.
Overview
Responsibilities
- Lead projects provide oversight of outsourced GxP bioanalytical validations and sample analysis from IND enabling stage to late development for PK PD and biomarker studies
- Accountable for the scientific guidance and design of the bioanalytical translational and clinical strategies and the (e.g. Biomarker) of therapeutic programs with different modalities
- Assure bioanalytical tasks are performed to high scientific standards with quality and within agreed timelines. This entails overseeing work by internal facilities or external vendors within a matrixstructured 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 collaborators (therapeutic areas clinical pharmacology clinical operations nonclinical safety contract research organizations etc. to build and to implement 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)
- Participate in vendor governance
- Identify evaluate and manage bioanalytical vendors partnering with the Procurement function.
- PhD or MS in Analytical Chemistry Chemistry Biochemistry or another relevant field.
- Minimum of 10 years postPhD experience or equivalent in the pharmaceutical or related industry within bioanalytical area focusing on small molecules and oligonucleotides
- Demonstrated method development and validation experience with various platforms with deep expertise in LC/MS regulated quantification
- Experience managing regulated small molecule LC/MS analysis at external service providers
- Demonstrated expertise in best practices recommended by FDA EMA CLSI to conduct development qualification and validation of assays (e.g. M10 Bioanalytical Method Validation)
- Advanced knowledge of various mass spectrometry platforms ionization methods quantitative analysis techniques for small molecules hybrid or biological molecules (eg. proteins peptides oligonucleotides etc.
- Experience with LC/MS analysis of other modalities (i.e. Biologics) is considered a bonus!
- Strong understanding and experience current GxP ICHM10 CAP/CLIA/ISO standard.
- Excellent people skills and the ability to function in a highly matrixed team environment
- Familiarity and experience in establishing clinical biomarker analyses for clinical trials
- Excellent communication skills (verbal and written) and presentation skills is required
- Knowledge of LIMS systems such as Watson or other data systems is considered a bonus!
Salary Range
Compensation & Benefits
At Insmed were committed to investing in every team members total wellbeing now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members regardless of geographic location:
- Flexible approach to how we work
- Health benefits and timeoff plans
- Competitive compensation package including bonus
- Equity Awards (LongTerm Incentives)
- Employee Stock Purchase Plan (ESPP)
For more information on U.S. benefits click here.
Additional Information
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability protected veteran status or any other characteristic protected by federal state or local law. 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.
Insmed is committed to providing access equal opportunity and reasonable accommodation for individuals with disabilities in employment its services programs and activities. To request reasonable accommodation to participate in the job application or interview process please contact us by email atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a casebycase basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Required Experience:
Director
Employment Type
Unclear
