Jobs in the United States

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Added 16 hours ago
Histology Technician
HCA Healthcare
Dallas, TX
…Performs histology and cytology procedures including specimen processing/fixation, cell block preparation, embedding, microtomy, slide preparation, routine and special stains, case…
Added 22 hours ago
Sr. Bioprocess Associate
Astellas Pharma
South San Francisco, CA
The Senior Associate, Technical Development Operations will participate in upstream and downstream areas of AAV development and production within process development and the pilot plant for…
Added 23 hours ago
SC
Clinical Cell Processing Associate
Seattle Children's
Seattle, WA
- $91,010 to $136,514 USD / year
This is an exciting position supporting the development of a new cell processing laboratory. This intermediate position requires significant understanding and some independent application…
Added 23 hours ago
Medical Lab Scientist I
AdventHealth
La Grange, IL
Facilitates workflow and support education to clinical staff as needed.
Added 1 day ago
Medical Technologist/Medical Laboratory Technician (MT/MLT), Molecular (DLS Oahu)
The Queen's Health Systems
Aiea, HI
Diagnostic Laboratory Services, Inc. (DLS) is Hawaii’s largest locally owned and operated clinical and anatomic pathology laboratory. DLS is proud to serve the communities of Hawaii, Guam…
Added 1 day ago
Associate Director, NGS & Bioinformatics
AstraZeneca Pharmaceuticals LP Company
Santa Monica Colorado Avenue, CA
AstraZeneca is looking for an Associate Director to join the NGS & Bioinformatics group within Cell Therapy Translational and Safety Sciences (CT-TSS). In this role, you will provide…
Added 1 day ago
Associate Director, NGS & Bioinformatics
AstraZeneca
Santa Monica, CA · Santa Monica
AstraZeneca is looking for an Associate Director to join the NGS & Bioinformatics group within Cell Therapy Translational and Safety Sciences (CT-TSS). In this role, you will provide…
Added 1 day ago
S
Divisional Office Manager
SAFY
Cincinnati, OH
- $17 to $25 USD / hour
Responsible for processing incoming and outgoing divisional mail.
Added 1 day ago
Sr. Manager/Assoc Director, Manufacturing Sciences & Technology (MSAT)
Genezen
Lexington, MA
…process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new…
Added 1 day ago
P
Associate Director/Director, Computational Test Development
Precede
Cambridge, MA
- $180,000 to $240,000 USD / year
…field. Direct experience with advanced NGS modalities (e.g., cell-free DNA, ChIP-Seq, or epigenomic signal processing) is highly…
Added 1 day ago
OB
Associate, Cell Therapy Production, 1st Shift
Orca Bio
Sacramento, CA
- $23 to $28 USD / hour
We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy…
Added 1 day ago
Sr. Bioprocess Associate
Astellas
South San Francisco, CA
The Senior Associate, Technical Development Operations will participate in upstream and downstream areas of AAV development and production within process development and the pilot plant for…
Added 1 day ago
A
URGENTLY HIRING: GMP Scientist I
Actalent
Columbus, OH
- $24 USD / hour
Support all aspects of GMP operations and production in a clinical manufacturing facility focused on cell-based manufacturing.
Added 1 day ago
Associate Director, Clinical Pharmacology & DMPK
Summit Therapeutics
Palo Alto, CA
The Associate Director, Clinical Pharmacology & DMPK will manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM) and data analysis supports and operation for Summit’s…
Added 1 day ago
AB
Lead Manufacturing Associate, Upstream
Avid Bioservices
Tustin, CA
- $31.92 to $39.9 USD / hour
The Lead Manufacturing Associate, Upstream provides hands-on technical and frontline leadership for cGMP cell-culture manufacturing in a multi-product facility. The role supports…
Added 1 day ago
Core Technician– Cell Therapy
Lonza Houston Inc.
Houston, TX
As a Core Technician - Cell Therapy, you will play a critical role in the manufacturing of clinical and commercial cell therapy products within a highly regulated GMP environment. This…
Added 1 day ago
W
(USA) Pharmacy Technician, Central Fill, Health And Wellness Central Operations - Health And Wellness (S1 SMRF 5:45a-4:15p)
Walmart
PLAINFIELD, IN
- $20.5 to $33.5 USD / hour
Walmart Central Fill Pharmacy is a specialized type of pharmacy that focuses on processing and dispensing of prescriptions for multiple retail pharmacy locations within a region. Unlike a…
Added 2 days ago
Clinical Research Technician Underfill Assistant-Term Limited
University of Michigan
Ann Arbor, MI
The research assistant will support wet-laboratory studies focused on bone and joint biology, including tissue processing, cell culture, molecular assays, histology, and analysis of…
Added 2 days ago
Supervisor - Biomanufacturing, Downstream/mRNA
Catalent Pharma Solutions LLC
Madison, WI
…supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility…
Added 2 days ago
ST
Associate Director, Biomarker and Nonclinical Operations
Seismic Therapeutic Inc
Watertown, MA
- $170,000 to $230,000 USD / year
Oversee clinical sample processing and analysis at CROs and central laboratories, including collection and processing requirements, laboratory manuals, kits, shipments, and resolution of…
Added 2 days ago
E
Senior Associate Process Engineer (Contract)
ElevateBio
Waltham, MA
- $43 to $57 USD / hour
…support for technology transfers and cGMP manufacturing for both clinical and commercial stage programs across modalities including cell and gene therapy, mRNA and viral…
Added 2 days ago
Medical Lab Scientist I
Adventist Midwest Management Services
United States
Facilitates workflow and support education to clinical staff as needed.
Added 2 days ago
Senior Director, Manufacturing
Lyell Immunopharma
Bothell, WA
…hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing…
Added 2 days ago
W
(USA) Pharmacy Technician, Central Fill, Health And Wellness Central Operations - Health And Wellness (S2 TWRF 4p-2:30a)
Walmart
PLAINFIELD, IN
- $20.5 to $33.5 USD / hour
Walmart Central Fill Pharmacy is a specialized type of pharmacy that focuses on processing and dispensing of prescriptions for multiple retail pharmacy locations within a region. Unlike a…
Added 2 days ago
W
(USA) Certified Pharmacy Technician, Central Fill, Health And Wellness Central Operations - Health And Wellness (S2 TWRF 4p-2:30a)
Walmart
PLAINFIELD, IN
- $24 to $37 USD / hour
Walmart Central Fill Pharmacy is a specialized type of pharmacy that focuses on processing and dispensing of prescriptions for multiple retail pharmacy locations within a region. Unlike a…

Precede

Associate Director/Director, Computational Test Development

Cambridge, MA, United States

$180,000 to $240,000 USD / year

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Job details

Pay: $180,000 to $240,000 USD / year
Experience: 4–9 years of industry experience in regulated diagnostics, liquid biopsy, or IVD development, ideally within a fast-paced, cross-functional R&D environment.
Posting language: English
Posted: Oct 19, 2026

Original job description

The Opportunity

We are seeking a Director-level computational scientist to drive the analytical and regulatory dimensions of diagnostic test development at Precede Biosciences. Reporting to the Senior Director of Computational Test Development, this role sits at the center of our effort to bring a novel epigenomics-based liquid biopsy platform from late-stage development through FDA regulatory submission.

You will lead the analytical strategy and bioinformatics infrastructure verification that underlies our validation programs. You will drive the interpretation of complex data, guide pipeline execution, and author critical regulatory documentation in close partnership with laboratory, clinical, and regulatory teams.

About Us

We are pioneering an advanced, minimally invasive, comprehensive epigenomics platform with the potential to profoundly impact the research and development of new medicines and the use of approved medicines in clinical practice across a number of conditions, including cancer. More information on our company and platform can be found on our company website and in our seminal publication in Nature Medicine.

We care deeply about creating a place where folks can do their best work from the start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, and collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.

What You'll Do

Analytical Validation & Regulatory Execution

• Design and develop computational approaches for characterizing the performance of existing and new epigenomic tests.

• Define and implement metrics and analyses to assess NGS and epigenomic data quality to enable coordinated optimization of assay and diagnostic performance.

• Lead the computational execution of verification and validation protocols, statistical analysis plans (SAPs), and performance summary reports to meet FDA evidentiary standards.

• Translate complex computational results into clear, well-organized regulatory documentation for FDA submissions.

• Stay current on FDA guidance for IVDs, companion diagnostics, and evolving LDT oversight to actively inform study design decisions.

Statistical & Bioinformatics Analysis

• Develop and apply statistical methods for diagnostic characterization, including LOD/LOQ, reproducibility, thresholding, gaurdbanding, and clinical utility endpoints.

• Support and optimize robust, reproducible analysis pipelines - ensuring code traceability and standardization from raw NGS data through regulatory-grade outputs.

• Identify and systematically address sources of variability, bias, and technical confounding across the computational workflow.

Cross-Functional Collaboration

• Partner closely with laboratory development, clinical operations, and regulatory affairs to ensure absolute scientific and regulatory alignment across programs.

• Contribute to clinical study design - including sample size calculations, endpoint selection, and pre-specified SAPs using data-driven insights from analytical validation pilots.

Who You Are

• PhD in computational biology, bioinformatics, biostatistics, or a closely related quantitative field. Direct experience with advanced NGS modalities (e.g., cell-free DNA, ChIP-Seq, or epigenomic signal processing) is highly preferred.

• 4–9 years of industry experience in regulated diagnostics, liquid biopsy, or IVD development, ideally within a fast-paced, cross-functional R&D environment.

• Proven track record working under a formal Quality Management System (ISO 13485, 21 CFR Part 820).

• Hands-on experience contributing to regulatory submissions (such as Pre-Subs, De Novo, or 510(k) tracks). Please describe your specific role and submission type in your cover letter or CV.

• Solid grasp of analytical validation frameworks, including CLSI EP guidelines, FDA IVD/CDx guidance, and CAP/CLIA requirements.

• Fluency in R and/or Python for robust statistical modeling, data analysis, and reproducible reporting.

• Strong communication skills with a demonstrated ability to present and defend analytical validation strategies to internal leadership, scientific advisors, and regulatory stakeholders.

• Startup mindset: You thrive when taking autonomous ownership of projects, remain adaptive under evolving information, and execute effectively in an entrepreneurial environment.

We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks. Please don’t hesitate to apply!

Precede Biosciences is an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected.

Please note that we do not accept unsolicited resumes from recruitment agencies and external recruiters. No fees will be paid for such submissions.

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