Senior Manager/Associate Director, GMP Quality Assurance (Contract) at Orbital Therapeutics

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

B.S. or M.S. in a scientific discipline
6–8 years of biopharma experience, with at least 4 years of GMP QA experience in a manufacturing/CMC setting
RNA/LNP product experience strongly preferred
Experience with batch record review, vendor management, and QMS (Veeva strongly preferred)
Familiarity with FDA and EU GMP regulations; GCP/GLP exposure a plus
Hands-on, detail-oriented, with the ability to thrive in a lean, fast-paced biotech
Strong communication and interpersonal skills for effective cross-functional collaboration

Responsibilities

Serve as the primary internal GMP QA lead, ensuring compliance with FDA, EU, and other regulatory authorities
Manage and maintain Orbital’s electronic Quality Management System (Veeva), including change controls, deviations, and CAPAs
Conduct detailed technical review of GMP manufacturing batch records, validation reports, stability data, and product release documentation
Oversee vendor quality, including contract manufacturers, through audits, quality agreements, and issue resolution
Support qualification of contract manufacturing/testing sites and distribution depots
Participate in audits (domestic and international) to assess compliance status and mitigate risks
Collaborate cross-functionally with CMC and Regulatory teams to ensure timely, accurate quality deliverables
Provide input into long-term quality strategy, with an initial focus on GMP and an opportunity for future growth into GCP/GLP oversight

Skills

GMP

Quality Assurance

Veeva

Batch Record Review

Vendor Management

Audits

FDA Regulations

EU GMP

RNA

LNP

QMS

CAPAs

Deviations

Change Controls

Orbital Therapeutics

Develops RNA-based medicines and therapies

About Orbital Therapeutics

Orbital Therapeutics focuses on developing RNA-based medicines, specifically targeting areas like vaccines, immunomodulation, and protein replacement. The company utilizes RNA technology, advanced delivery methods, data science, and automation to create a platform for a wide range of therapeutic applications. Unlike many competitors, Orbital Therapeutics does not work with small interfering RNA, which sets it apart in the RNA medicine space. The goal is to enhance global health by harnessing RNA medicines to treat diseases in innovative ways that were not possible before. Revenue is generated through the sale of these RNA-based therapies to healthcare providers, who then administer them to patients.

San Francisco, CaliforniaHeadquarters

2022Year Founded

$262.6MTotal Funding

SERIES_ACompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Risks

Increased competition from companies like Moderna and BioNTech could challenge Orbital.

Potential regulatory hurdles could delay RNA-based therapy product approvals.

Rapid technological advancements may require continuous R&D investment, straining resources.

Differentiation

Orbital Therapeutics focuses on RNA-based medicines excluding small interfering RNA.

The company integrates RNA technology with delivery techniques, data analytics, and automation.

Orbital's initial focus is on vaccines, immunomodulation, and protein replacement.

Upsides

RNA-based vaccines are gaining traction for rapid response to emerging diseases.

Advancements in lipid nanoparticle technology enhance RNA therapeutic delivery efficiency.

The trend of personalized medicine increases demand for RNA-based therapies.

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