Senior Specialist, External Quality - New Haven

Provide Quality partnership and oversight to the Product Development Clinical Supply at the New Haven site and at external CLO/CMO's. · ...

Provide Quality partnership and oversight to the Product Development Clinical Supply (PDCS) at the New Haven site and at external CLO/CMO's. · ...

The Analytical Sciences Quality Lead will provide quality oversight of internal/external testing, stability, analytical technical transfer and quality systems elements in a matrix environment. · ...

The Analytical Sciences Quality Lead will provide quality oversight of internal/external testing, · stability, analytical technical transfer and quality systems elements in a matrix environment.Principal Responsibilities include review of technical documents, · analytical method ...

The Analytical Sciences Quality Lead provides quality partnership and oversight to the Product Development Clinical Supply at the New Haven site and at external CLO/CMO's. · Review of technical documents, analytical method validation and transfers for Phase I to III clinical prod ...

We are looking for a strong analytical candidate with quality assurance experience and a background in clinical testing. As Analytical Sciences Quality Lead, you will provide quality partnership and oversight to the Product Development Clinical Supply (PDCS) at the New Haven site ...

Location: New Haven, CT (Northeast Preferred) · Position Summary: · The Senior Quality Manager helps to establish, oversee, update, and maintain drug substance and drug product testing. The ideal candidate is an experienced leader with deep expertise in biopharmaceutical QC relea ...

We are looking for an experienced Senior Director of Chemistry Quality Assurance to lead in GMP chemistry quality oversight across Invicro radiopharmaceutical manufacturing in New Haven, CT, · US and London, · UK.The role will be responsible for collaborating with research partne ...

The Quality Control Lead maintains collaborative relationships with teams to implement GMP standards. · Maintains batch record review process. · Reviews clinical batch records. · Demonstrate risk-based decision making in quality systems development. · ...

+Our client is seeking an Analytical Sciences Quality Lead who will provide Quality partnership and oversight of internal /external testing, · stability, analytical technical transfer and quality systems elements in a matrix environment. · ...

Location: New Haven, CT (Northeast Preferred) · Position Summary: · The Senior Manager, Scientific Writing will be responsible for assisting in the development and execution of the medical communication strategy and tactics. In addition, they will create high-quality resources th ...

We take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases. · Be part of making a difference. Be part of Invivyd. · Review and approve relevant GMP documents for compliance to Invivyd's Quality Manag ...

The Analytical Sciences Quality Lead provides quality partnership and oversight for Product Development Clinical Supply (PDCS) activities at the New Haven site and external CLOs/CMOs.8+ years of cGMP Quality Assurance experience in biotech or pharmaceutical environments. · BSc or ...

The Analytical Sciences Quality Lead provides quality partnership and oversight for Product Development Clinical Supply (PDCS) activities at the New Haven site and external CLOs/CMOs. · 8+ years of cGMP Quality Assurance experience in biotech or pharmaceutical environments. · BSc ...

The position is a multi-disciplinary role that requires in-depth data management knowledge and external data management expertise. · ...

The Analytical Sciences Quality Lead will provide quality oversight of internal/external testing, stability, analytical technical transfer and quality systems elements in a matrix environment. · ...

This Is What You Will Do · This Development Scientist III will be a key team member in Alexion's External Analytical Development and Quality Control group. This position is responsible for end-to-end oversight of outsourced analytical testing activities to ensure timely, complian ...

The Analytical Sciences Quality Lead provides quality partnership and oversight for Product Development Clinical Supply activities at the New Haven site and external CLOs/CMOs. · ...

We take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. · In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody ...

The hiring manager is looking for a strong analytical candidate with quality assurance experience and a background in clinical testing · Provide Quality partnership and oversight to the Product Development Clinical Supply (PDCS) at the New Haven site and at external CLO/CMO's. · ...