Pharmaceutical Bioanalysis Lead

3 weeks ago


Cambridge, Massachusetts, United States Alnylam Full time

Job Description

As a Senior Pharmaceutical Bioanalysis Lead at Alnylam, you will play a critical role in advancing our RNAi therapeutic programs from discovery to the clinic.

You will be responsible for managing outsourced efforts to design and implement fit-for-purpose methods across various platform technologies, as well as the subsequent use of these assays for nonclinical or clinical bioanalytical sample analysis.

This position is onsite and will be primarily located in Cambridge, MA. You will have the opportunity to work with highly motivated scientists across a broad array of disciplinary expertise areas.

Responsibilities

  • Provide scientific support for CRO efforts in the design, development, and implementation of a variety of analytical methods in a regulated environment.
  • Serve as a subject matter expert in the application of bioanalytical techniques (LC-MS, ELISA, MSD, PCR, cell-based assays) to support PK, PD, biomarker, or immunogenicity objectives in nonclinical or clinical studies.
  • Leverage depth of knowledge and hands-on experience with bioanalytical techniques to advise on assay design, method validation design, and interpretation of method performance data.
  • Collaborate with Alnylam bioanalytical scientists to ensure successful method transfer and continuity in PK or PD biomarker testing from discovery through development.

Requirements

  • PhD in biochemistry, chemistry, molecular/cell biology, or related field with 6+ years of relevant industry experience, or non-PhD with 10+ years of experience.
  • Hands-on experience with the use of bioanalytical techniques such as ELISA, MSD, LC-MS, PCR, or cell-based methods to support PK, PD, or immunogenicity evaluations.
  • Previous experience in conducting or managing regulated (GLP, GCLP, CLIA) bioanalysis studies.

Estimated Salary:$145,000 - $170,000 per year, depending on experience.



  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    About Takeda PharmaceuticalOverview:Takeda Pharmaceutical is a leading global biopharmaceutical company dedicated to delivering innovative medicines to patients worldwide. Our commitment to creating a diverse workforce and providing equal employment opportunities has earned us a reputation as an employer of choice.Job Summary:We are seeking an experienced...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Takeda Pharmaceutical is seeking a talented and motivated professional to lead its global team of managers and scientists in the field of analytical controls and compliance. As Vice President, Pharmaceutical Sciences, you will be responsible for overseeing and managing core tasks for analytical controls, contributing to product development, and implementing...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Cambridge, MA is home to our research and development center, where our teams are pushing the boundaries of innovation in the pharmaceutical industry. We are seeking an experienced Process Engineer to join our team and contribute to the development of innovative solutions for the pharmaceutical industry.About the RoleThis is an exciting opportunity for a...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleThis Senior Manager role is responsible for leading the Analytical Controls team and overseeing the global CMC program. The successful candidate will have extensive experience in pharmaceutical development and management, with expertise in GMP and compliance.The ideal candidate will have strong leadership skills and be able to manage and...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Transformative Role in Pharmaceutical DevelopmentTakeda Pharmaceutical seeks a highly skilled and innovative Associate Engineering Fellow to lead process engineering strategy for Synthetic Molecule Process Development (SMPD). This pivotal role will contribute to the development of robust, sustainable, and cost-effective processes for manufacturing new...


  • Cambridge, Massachusetts, United States Alnylam Full time

    Alnylam Pharmaceuticals is seeking a Bioanalytics Development Manager to join our team in Cambridge, MA. This individual will be responsible for developing and implementing fit-for-purpose analytical methods across various platform technologies, as well as the subsequent use of these assays for nonclinical or clinical bioanalytical sample analysis.This...


  • Cambridge, Massachusetts, United States TrovaTal Full time

    Lead Financial Planning and Analysis for a Global Pharmaceutical CompanyAbout the Role:We are seeking an experienced Senior Financial Analyst to lead financial planning, budgeting, and forecasting efforts for a global pharmaceutical company. As a key member of our finance team, you will provide critical financial insights to support strategic...


  • Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full time

    Job Title: VP of Pharmaceutical Risk ManagementWe are seeking an experienced professional to lead our pharmaceutical risk management efforts as the VP of Pharmaceutical Risk Management. In this role, you will be responsible for identifying, assessing, and mitigating risks associated with our pharmaceutical products.ResponsibilitiesIdentify, assess, and...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    Job Description:The role of a Pharmaceutical Content Specialist involves creating and overseeing critical documents for regulatory filings, clinical studies, and publications. This includes protocols, reports, consent forms, and manuscripts.Primary Responsibilities:Lead and write clinical documents like protocols, reports, brochures, and regulatory...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleWe are seeking a seasoned leader to oversee our global analytical controls functions. As Head of Global Analytical Controls Leadership, you will be responsible for leading a team of managers and scientists in developing and implementing strategies for analytical control topics, development requirements, and program milestones.This is an...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleAt Takeda Pharmaceutical, we are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status,...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Takeda Pharmaceutical seeks an exceptional leader to oversee its global team of managers and scientists in the field of analytical controls and compliance. As Director of Analytical Operations, you will be responsible for leading core tasks for analytical controls, contributing to product development, and implementing externalization activities with external...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Takeda Pharmaceutical is seeking a highly experienced professional to join its team as Head of Analytical Development. This exciting opportunity offers a unique chance to lead global teams in the field of analytical controls and compliance.Job Description:The ideal candidate will possess extensive experience in CMC analytical development, regulatory...


  • Cambridge, Massachusetts, United States Alnylam Full time

    Responsibilities* Provide scientific support for CRO efforts in the design, development, and implementation of analytical methods in a regulated environment* Serve as a subject matter expert in the application of bioanalytical techniques to support PK, PD, biomarker, or immunogenicity objectives in nonclinical or clinical studies* Collaborate with Alnylam...


  • Cambridge, Massachusetts, United States Alnylam Full time

    Alnylam Pharmaceuticals is seeking a highly skilled Senior Bioanalytical Research Scientist to join our team in Cambridge, MA. This individual will be responsible for managing outsourced efforts to design and implement fit-for-purpose analytical methods across various platform technologies, as well as the subsequent use of these assays for nonclinical or...


  • Cambridge, Massachusetts, United States Lifelancer Full time

    About the Role: We are seeking a highly experienced Senior Principal Specialist, Supplier Quality to join our team at Lifelancer. This strategic leadership role is responsible for managing and overseeing suppliers and contract manufacturing organizations (CMOs) to ensure compliance with industry and regulatory standards. Key Responsibilities: Develop...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Welcome to Takeda Pharmaceutical, a world-leading biopharmaceutical company dedicated to improving lives through innovative medicines.About Us:We strive to create a diverse and inclusive work environment that fosters collaboration, creativity, and growth. Our commitment to equality and fairness has earned us recognition as an employer of choice.Job...


  • Cambridge, Massachusetts, United States TrovaTal Full time

    Are you an experienced financial professional seeking a challenging role in the pharmaceutical industry? TrovaTal is working with a global company that needs a skilled Strategic Financial Planning Manager to lead their financial planning and analysis efforts.About the RoleThis is a unique opportunity to join a leading pharmaceutical company as a Strategic...


  • Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time

    Job SummaryWe are seeking a highly experienced and skilled professional to lead our global analytical development team. As the Head of Analytical Controls, you will be responsible for overseeing the development and implementation of analytical methods, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to drive...


  • Cambridge, Massachusetts, United States Eurofins USA Discovery Services Full time

    Business Development OpportunityWe are seeking a results-driven Pharmaceutical Business Development Specialist to join our team in the United States. As a Business Development Specialist, you will be responsible for identifying and pursuing new business opportunities, building strategic relationships with clients, and driving revenue growth.The ideal...