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Mersana Therapeutics
Cambridge, Massachusetts, United States
30+ days ago
Mersana Therapeutics
Cambridge, Massachusetts, United States
30+ days ago

Description

What’s in it for you?

In this role, you will have the opportunity to be a vital part of Mersana’s growth and success, as you will oversee and manage Mersana’s bioanalytical outsourcing activities for PK/TK and Immunogenicity for our ADCs. As part of the Clinical Pharmacology Group, you will manage and oversee outsourced bioanalytical method development, validation, and sample analysis activities at our partner CROs. While doing this, you will form close partnerships with internal cross-functional team members from the Nonclinical Development team, Clinical Operations, the Clinical Pharmacologists and PK data analysts. Your work will ensure the quality and scientific soundness of the data and reports generated to support both our non-clinical and clinical studies, which will directly impact progress towards Mersana’s goal of creating a world where all patients triumph over cancer.

As the Project Manager, Bioanalytical Sciences, you will learn about our propriety ADC platform technology, which is being deployed to treat a number of oncology targets, and help to oversee state of the art assay techniques to support their development and approval. As more projects come online, this function is expected to grow, and we are looking for someone to help define the future needs and growth of this role. As such you will have the opportunity to oversee future hires and build a team of future direct reports. This role reports into the head of Clinical Pharmacology, that sits within the development organization at Mersana.

How do you know if you’re the right fit?


To be successful, you will have previously worked in the bioanalysis field and be familiar with LCMS and ligand binding methodologies, including methods for measuring immunogenicity. You will also have demonstrated excellent project management skills and work well in a matrixed organization where you have formed strong cross-functional partnerships with both technical and operational people. You will be expected to manage to relationships with our partner BA CROs, agree upon the costs and budgets, and oversee the set up of contracts for the GLP and clinical assay work.

If you are a highly self-motivated, driven individual who enjoys the challenges and opportunities available in a growing and transforming organization, this will be an opportunity for you to apply yourself, learn and deliver. You’ll thrive in an environment where you are involved in both the strategy (the bigger picture) and in the execution, and value proactive collaboration and teamwork to be successful.   

Your experience will allow you to excel at the following:

  • Being the primary point of contact with our partner CROs for all Bioanalysis samples (clinical and nonclinical, GLP), liaising with these CROs for effective planning and operational conduct of the studies (e.g. bioanalytical sample management), and technical execution (e.g. data transfer and management, study report and data QC) as needed.
  • Ensuring that all deliverables are met per agreed SOWs and study timelines. Provide input on CRO performance, escalating concerns as appropriate.
  • Using your technical expertise to be able to engage with the internal Mersana Bioanalysis Group to ensure adequate development and validation activities to support bioanalysis for antibody drug conjugates (ADC), bioanalysis for clinical / non-clinical projects using LC-MS/MS, and other assay types such as Ligand binding methodologies.
  • Overseeing both PK and ADA/Nab assays.
  • Collaborating closely with our internal Bioanalysis Group, you will coordinate the transfer of the bioanalysis methods to our selected CROs so that the GLP-nonclinical/clinically validated bioanalytical methods are in place and ready to support the start of our studies.
  • Providing bioanalytical operational expertise to internal and external non-clinical/clinical trial teams, implementing and executing bioanalytical strategies in all phases of the drug development pipeline.
  • Serving as a single point of contact between Clinical Program Team and external bioanalytical labs (BA CRO). Where the engagement is for GLP TK assays you will partner with the Non-Clinical Development group in the interaction with the BA CRO.
  • Ensuring the timely and efficient delivery of all bioanalytical operational aspects for clinical trials, in accordance with applicable quality and regulatory standards.
  • Defining, coordinating, managing, and overseeing the bioanalytical project timeline.
  • You will be responsible for the scientific quality of the bioanalytical projects in support of clinical and non-clinical development.


The Other Stuff

This role is best suited to someone with:

  • A Ph.D. in Biological Sciences, Chemistry or equivalent with 3+ years of related experience; M.S. with 8+ years of related experience; or B.S. with 12+ years of related experience.
  • Experience in bioanalytical method development, validation, and sample analysis in small molecule analysis by LC-MS/MS required, experience with ADCs preferred.
  • Experience either working in a CRO or managing overseeing work conducted at CROs.
  • Previous experience in a GLP, GCP, and/or CLIA compliant bioanalytical lab environment is required.
  • Experience in standard program management processes and demonstrated project coordination skills with multiple projects covering internal and external stakeholders
  • Strong written, verbal, and interpersonal communications skills, including the ability to communicate scientific information clearly and effectively.
  • A high level of intellectual curiosity, innovation, and creative problem solving with an entrepreneurial spirit; and the ability to thrive in an agile environment.
  • A highly organized and detail-oriented mind, with a passion for delivering quality results.

Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation, and paid holidays.

Successful candidate must be authorized to work in the United States.

Mersana Therapeutics, Inc. is an equal opportunity employer.



Job Information

  • Job ID: 62638694
  • Location:
    Cambridge, Massachusetts, United States
  • Position Title: Project Manager, Bioanalytical Sciences
  • Company Name For Job: Mersana Therapeutics
  • Job Function: Analyst,
    Biochemistry,
    Chemist
  • Job Type: Full-Time

Please refer to the company's website or job descriptions to learn more about them.

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