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Remote Analytical Method Development Jobs in Massachusetts

Stoke Therapeutics

Director, CMC Lead

Bedford, MA ยท On-site +1

... development, analytical methods, tech transfer, manufacturing, CMC regulatory strategy and health ... This position is eligible for either remote or hybrid work arrangements. Travel: This position will ...

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Remote Analytical Method Development information

What is remote analytical method development?

Remote analytical method development refers to the process of designing, optimizing, and validating laboratory analytical methods from a remote location, often using digital collaboration tools and cloud-based laboratory software. Professionals in this field work with clients or laboratory teams to develop protocols for analyzing chemical, biological, or physical samples without being physically present in a central lab. This approach enables organizations to leverage global expertise, streamline workflows, and maintain productivity, especially in situations where on-site access is limited.

What are the key skills and qualifications needed to thrive in remote analytical method development?

To thrive in Remote Analytical Method Development, you need a solid background in chemistry or related sciences, expertise in analytical techniques (such as HPLC, GC, or spectroscopy), and often a relevant degree (BSc, MSc, or PhD). Familiarity with laboratory information management systems (LIMS), data analysis software, and validation protocols is typical, and certifications like ISO or GLP compliance can be advantageous. Strong problem-solving skills, attention to detail, and effective virtual communication are essential soft skills for collaborating with remote teams and addressing complex analytical challenges. These skills ensure accurate method development, regulatory compliance, and successful project outcomes in a distributed work environment.

What are some typical challenges faced by professionals in a remote analytical method development role, and how can they be addressed?

Professionals in remote analytical method development often encounter challenges such as limited access to laboratory equipment, coordinating experiments across distributed teams, and ensuring data integrity when working with digital tools. To overcome these, it's important to establish clear communication protocols, leverage remote-access lab technologies, and use validated software platforms for data analysis and documentation. Regular virtual meetings and collaboration with on-site lab personnel also help ensure method development progresses smoothly and stays aligned with project goals.

What is the difference between Remote Analytical Method Development vs Remote Analytical Method Validation?

AspectRemote Analytical Method DevelopmentRemote Analytical Method Validation
Primary FocusDeveloping new analytical methods for testing samplesConfirming that existing methods meet quality and regulatory standards
Work EnvironmentLaboratory setting, often collaborative, with some remote tasksPrimarily desk-based, reviewing data, documentation, and performing validation activities remotely
Required CredentialsDegree in Chemistry, Biochemistry, or related field; certifications varySimilar credentials; often requires experience with validation protocols and regulatory guidelines

Remote Analytical Method Development focuses on creating new testing procedures, while Remote Analytical Method Validation ensures these methods are reliable and compliant. Both roles share similar educational backgrounds and often operate in regulated industries like pharmaceuticals and biotech, but their core activities differ in development versus validation tasks.

What are the most commonly searched types of Analytical Method Development jobs in Massachusetts?

The most popular types of Analytical Method Development jobs in Massachusetts are:

What are popular job titles related to Remote Analytical Method Development jobs in Massachusetts?

For Remote Analytical Method Development jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Remote Analytical Method Development jobs in Massachusetts look for?

The top searched job categories for Remote Analytical Method Development jobs in Massachusetts are:

What cities in Massachusetts are hiring for Remote Analytical Method Development jobs?

Cities in Massachusetts with the most Remote Analytical Method Development job openings:

Remote Analytical Method Development jobs near you

Director, Analytical Development

Keros Therapeutics

Lexington, MA โ€ข On-site, Remote

Full-time

Posted 28 days ago

Job description

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-รŸ) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-ฮฒ signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-ฮฒ superfamily and provide disease-modifying benefit to patients.
Job Summary
Keros Therapeutics is seeking an expert in Analytical Science and Protein Characterization to join our team as Director of Analytical Development. The incumbent will lead the analytical strategy, method development, and characterization for our novel protein pipeline. The ideal candidate will have a deep understanding of protein characterization hands-on experience in the laboratory, excellent organizational skills and attention to detail, a demonstrated ability for self-motivated and independent project execution, and a strong desire to learn. This position requires deep expertise in modern analytical chemistry and a strong ability to translate complex data into actionable scientific decisions. The ideal candidate will combine technical depth with proven leadership experience, sound scientific judgment, and the ability to build productive partnerships across internal teams and external collaborators.
Primary Responsibilities
  • Lead analytical development strategy for early to late-stage biologics programs, including Pre-Clinical, Phase I and Phase II/III
  • Develop the strategic implementation of increasing levels of structural, physical, and advanced protein characterization in phase appropriate manner
  • Serve as the subject-matter expert in protein characterization and stability for phase-appropriate development of the pipeline
  • Partner with Manufacturing, Process Development, and Quality teams to define and implement phase-appropriate analytical methods, specifications, and control strategies to support DS and DP
  • Advise and oversee CDMOs' analytical method development, transfer, and validation
  • Collaborate with CDMOs and CROs to develop and optimize a range of analytical assays for the release and characterization on a series of fusion protein and mAb biologics at each stage from preclinical to commercial launch
  • Provide oversight of CDMOs and external testing laboratories, ensuring timelines, data quality, and compliance
  • Ensure analytical methods and specifications are scientifically justified, phase appropriate, and compliant with applicable compendial standards and regulatory guidelines
  • Support comparability, stability, and characterization strategies for process changes and scale-up
  • Provide and develop laboratory based analytical support to upstream and downstream process development to drive new and improved processes for DS production
  • Provide leadership and mentorship to a team of scientists and analysts
  • Support cross-functional team coordinating efforts of the Technical Operations, Quality, and Regulatory to advance programs
  • Drive analytical support for regulatory submissions, including IND amendments, BLA/MAA filings, and responses to health authority questions
  • Author Analytical CMC sections of IND filings, internal SOPs, experimental procedures, training and safety documents

Core Competencies (Required Skills)
  • Experience with biologics analytical support in late-stage activities (Phase 3 and commercialization)
  • Strong background in protein characterization, analytical method development, qualification/validation, and physicochemical characterization of fusion proteins and protein therapeutics
  • Deep understanding of analytical methods and data interpretation to evaluate protein structure, post translational modifications, and characterization
  • Experience supporting transitions from discovery through IND-enabling or early clinical development is strongly valued

Education Requirements and Qualifications
  • MS with 10+ years or PhD with 7+ years in molecular/cellular/structural biology, biochemistry, or a related field
  • Proficiency with biochemical and biophysical methods:
    • CE (CSDS, CIEF and CGE DNA), qPCR, potency, MFI/HIAC, DSF, DLS, DSC, and LCMS/MS peptide mapping & subunit analysis
    • Chromatography: IA, SEC, RP, HIC and IEX
    • Glycosylation: monosaccharide, sialic acid characterization and N-linked Glycan analysis
    • Spectroscopy: UV/Vis, luminescence
  • Experience in biochemistry techniques such as protein expression, gel electrophoresis, protein quantification assays, ELISA, cell-based assays, and enzyme kinetics
  • Understanding of molecular biology, recombinant protein expression and construct design for affinity purification methods; familiarity with standard expression hosts such as mammalian, is a plus
  • Experience in purifying proteins through recombinant processes is a plus
  • Excellent collaboration skills and ability to work cross functionally to achieve objectives
  • Strong work ethic, motivation, and scientific curiosity

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
Potential base pay range
$200,000-$226,000 USD
Our Diversity, Equity & Inclusion Mission Statement:Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Recruitment & Staffing Agencies:Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.

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