Associate Director Translational Bioanalytical Sciences - Bridgewater, United States - Insmed Incorporated

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 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

Named Science's Top Employer in 2021, 2022, and 2023

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 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 BiopharmaTM, Best Workplaces in New YorkTM, and Best Workplaces for MillennialsTM 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.
• Accountable for the scientific guidance and design of the bioanalytical translational and clinical strategies and the execution (e.g. Biomarker) of therapeutic programs with different modalities.
• 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 standards
• Excellent 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

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 based
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

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 until the position is filled.