VP, Pharmaceutical Quality at Dyno Therapeutics

Waltham, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Bachelor’s degree in science or a related field; advanced degree strongly preferred
15+ years’ experience in the pharmaceutical or biotechnology industry in cGMP quality and compliance role
5+ years’ experience as a functional head of a quality department
Strong cGMP knowledge in the pharmaceutical industry and implementing a phase-appropriate cGMP quality system
Hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)
Proven record of developing and maintaining successful working relationships with regulatory agencies
Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing
Strong experience and knowledge of cGMP manufacturing and stability to support BLAs/NDAs
Strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
Experience managing complex schedules and priorities in dynamic pharmaceutical environment

Responsibilities

Design, implement and maintain cGMP QA and QC programs, and the compliance infrastructure, including the cGMP-related SOP system, training programs, and performing internal and external audits
Work with the company’s external suppliers including clinical manufacturing organizations (CMOs) and contract labs to ensure consistent cGMP quality and compliance
Direct development and implementation of cGMP quality systems to ensure product reliability, quality, efficacy, compliance with applicable SOPs, cGMP regulations; phase-appropriate quality systems and approach
Lead resolution of product complaint, OOS and OOT investigations in phase-appropriate manner; lead and manage Material Review Board (MRB)
Lead setting up and managing stability program for pre-commercial and commercial products; data analyses and stability sections of regulatory filings
Oversee cGMP compliant auditing program to fulfill regulatory requirements
Develop, manage and monitor adherence to the overall Quality and Compliance at Dyne
Develop, analyze and report business metrics and highlights; manage department budget
Manage inspections by the FDA, other regulatory agencies and commercial partners at CMOs
Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements
Manage and build a team suitable for the growing needs of the organization

Skills

Key technologies and capabilities for this role

cGMPQuality AssuranceQuality ControlSOPAuditingRegulatory ComplianceGMPCMO ManagementContract LabsInternal AuditsExternal AuditsRegulatory FilingsInspections

Questions & Answers

Common questions about this position

Is this role remote or based in a specific location?

This role is based in Waltham, MA without the possibility of being fully remote.

What education and experience are required for this position?

A Bachelor’s degree in science or a related field is required, with an advanced degree strongly preferred, along with 15+ years of experience.

What are the main responsibilities of the VP, Pharmaceutical Quality?

The role involves overseeing cGMP compliance, managing QA and QC programs, working with external suppliers and CMOs, leading audits and investigations, and building a quality team.

What salary or compensation does this role offer?

This information is not specified in the job description.

What makes a strong candidate for this VP role?

Candidates with an advanced degree, 15+ years of cGMP experience in pharma/biotech, expertise in QA/QC oversight at CMOs, and leadership skills to build and manage a growing quality team will stand out.

Dyno Therapeutics

Develops AI-optimized gene therapy vectors

About Dyno Therapeutics

Dyno Therapeutics focuses on advancing gene therapy by utilizing Artificial Intelligence to create Adeno-associated virus (AAV) vectors. These vectors are essential tools for delivering genetic material into cells, which is crucial for effective gene therapy. The company's AI technology enables the design and optimization of these vectors, potentially enhancing the success of gene therapies. Dyno collaborates with major pharmaceutical and biotech companies, such as Astellas, Roche, Sarepta, and Novartis, to develop therapies for various diseases affecting the skeletal and cardiac muscles, central nervous system, liver, and eyes. Unlike many competitors, Dyno's unique approach leverages AI to improve the performance of AAV vectors, setting it apart in the biotech field. The company's goal is to improve gene therapy outcomes through its advanced vector technology, ultimately benefiting patients with serious health conditions.

Watertown, MassachusettsHeadquarters

2018Year Founded

$106MTotal Funding

SERIES_ACompany Stage

AI & Machine Learning, Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Remote Work Options

Risks

Gene therapy investment slowdown may impact Dyno's growth and innovation.

Manufacturing bottlenecks could hinder scaling of Dyno's operations.

Increased competition from companies like Form Bio challenges Dyno's market position.

Differentiation

Dyno uses AI to design optimized AAV vectors for gene therapy.

Their AI-driven CapsidMap platform enhances AAV vector development for muscle gene therapies.

Partnerships with major pharma companies like Astellas and Roche boost Dyno's market presence.

Upsides

AI-driven capsid design improves delivery efficiency and reduces manufacturing costs.

Collaboration with NVIDIA enhances biological sequence design for gene therapies.

Generative AI increases efficiency of eye and brain-targeted capsid delivery significantly.

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