Manufacturing Specialist, External Manufacturing Quality- Contract

Candel Therapeutics•Needham, MA

11d•$143,000 - $155,000•Hybrid

About The Position

The Manufacturing Specialist (External Manufacturing) is a key member of the Tech Ops organization responsible for ensuring that external manufacturing partners meet all quality, compliance, and operational expectations. In a highly cross functional role, this individual provides technical oversight, quality support, and issue management for products manufactured outside the Needham facility. The Specialist also plays a critical role in supporting the readiness and shipment or receiving of materials/products.

Requirements

Minimum 5 years GMP experience in biotech/life sciences (MUST HAVE).
Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.

Nice To Haves

Viral vector / gene therapy experience is a plus, not required.
Startup experience preferred but not required
A degree in a related field (engineering, chemistry, biology etc.) a plus, but not required

Responsibilities

Ensure external manufacturing partners comply with internal quality standards, specifications, and regulatory requirements.
Review and approve supplier/Contract Manufacturer production documentation including batch records. work instructions, development reports, and quality records.
Manage investigations into externally manufactured product issues, including deviations and change controls
Facilitate structured problem-solving (5‑Why, Fishbone, A3) with external partners through virtual collaboration.
Confirm effectiveness and sustainability of corrective and preventive actions (CAPA).
Review process controls, capability data, and SPC trends provided by external manufacturing sites.
Support validation, qualification, and change control activities through documentation and technical review.
Ensure external production processes align with internal requirements for consistency, traceability, and compliance.
Coordinate with external manufacturers, Quality, and Supply Chain to support shipment of materials/products and receiving of materials to the Needham site. Follow related SOPs regarding shipping or receiving of product or samples.
Verify that clinical shipments meet all release criteria, documentation requirements, and chain-of-custody expectations.
Ensure packaging, labeling, and documentation comply with clinical study protocols and regulatory standards.
Investigate and resolve any shipment-related discrepancies, delays, or quality issues.
Maintain complete and accurate documentation for deviations and change control
Ensure compliance with all applicable internal procedures and external quality system standards (ISO, FDA, etc.).
Provide clear and timely updates to Tech Ops leadership on supplier performance, risks, issues, and resolutions.
The role will support Manufacturing and Supply chain directly, but will include cross-functional work with AD, clinical and non-clinical groups.
Facilitate alignment between internal engineering/operations and external manufacturing partners on changes or escalations.
Prepare dashboards and reports summarizing external manufacturing operations status.