Biotechnology jobs

The successful candidate will be responsible to provide Process/Quality Engineering support to manufacturing helping to ensure delivery of highest quality product to the customer. Provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product d

The QA Manager will assure the management of the Quality System and Business Compliance to ensure they remain effective. You will also provide assurance of compliance with defined standards and/or specified customer requirements. This Position is necessary to create and manage the site according the ISO 9001:2015 requirements including R&D, SLS, and other Service departments.

The successful candidate will be responsible for the management of the Complaint Handling system, CAs, NCMRs and Deviation systems. The candidate will work closely with the manufacturing team assisting with root cause analysis and risk assessments. They will work closely with the document control department to ensure the changes are accurate and are made effective in a timely manner.

The Quality Assurance Associate II will report directly to the QA Director and is responsible to actively participate in the ISO 9001 Quality Management System. This role <span style="font-family:verdana,sans-se

• This individual will be helping in the successful launch of multiple products as well as well as a brand new molecular biology application.
• Drive new product develop planning process, create content and product messaging, and work cross functionally to ensure successful product launches

The ideal candidate must be innovative, creative and resourceful; skilled in identifying and solving problems. They will be a self-starter, self-initiated, highly motivated, a team player, and willing to participate cross-functionally. They must be an excellent communicator, both written and verbally. He/She must be willing to do whatever it takes to achieve goals and objectives.

The Quality Assurance Lead will report directly to the QA Director.This position is responsible to actively participate in the ISO 9001 Quality Management System. This role will be responsible for the management of Quality Associates in support of product release. They are responsible for supervising the daily schedule and assigning tasks to their direct reports. Must work independently and manage short and long-term priorities.

Reporting to the VP of Quality, the Supplier Quality Engineering Manager will be responsible for Supplier oversight to ensure, Quality, Compliance, and Regulatory requirements. This individual will work cross-functionally with the engineering team for both onboarding new suppliers, especially contract manufacturers,and monitor performance of existing suppliers in a sustaining role.

Reporting to the SVP & Head Business Development, CMC, the BD Director, CMC will play a key leadership role in identifying, developing and delivering new business opportunities in the Mid-Atlantic territory through to Florida. This position will be remote with the expectation to meet customers across the territory (virtually for now) and work closely with key internal stakeholders - ideally based out of NC.

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  An exciting opportunity to oversee project from start to completion
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  Drive business development in growing biotech market

The R&D Program Management & Operations, Director/Sr. Director will play an integral role in the project management of one or more of programs that are part of the client's wholly owned pipeline.

The incumbent of this role will be responsible for providing quality oversight over the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will supervise change control specialists responsible for managing change control activities throughout the lifecycle.

The Program Manager will be responsible for managing multiple milestone-driven programs and enabling success of program objectives and overall corporate goals. The individual to join an exciting and fast-paced team focused on improving global health through highly innovative CRISPR and Synthetic Biology-based platforms for molecular diagnostics.

The successful candidate will be responsible to provide Process/Quality Engineering support to manufacturing helping to ensure delivery of highest quality product to the customer. Provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product d