The senior buyer will evaluate the requirements, source the appropriate vendors, negotiate the contract, manage the cost and quality improvement, and assist the end user to make strategic sourcing decision. The person will be the local representative of Procurement in the North America, support the global strategic relationship establishment with key local vendors, and facilitate certain import/export activities.

Reporting to senior leadership, this individual will play a key leadership role in identifying, developing and delivering new business opportunities for Phase I full service clinical studies and other services.

This will be the second BD rep hired on the East Coast and can be based remotely anywhere in the territory.

The GMP Quality Assurance Manager will lead QA support of clinical phase manufacturing and regulatory activities, management of batch manufacturing and testing activities at CMOs and CTLs to ensure cGMP compliance, and administration of document control in company's system.

Oversee and execute projects in the immunotherapy space to generate therapeutic antibodies. Manage the CROs and CMOs for those outsourced projects.

Oversee and execute projects in the cell/gene therapy manufacturing space. Establish strong internal and client relationships while working across team functions.

This role will lead the client's PBPK modeling team in the translational medicine department. He/she will have the opportunity to lead PBPK projects with end to end applications of their modeling efforts from early discovery to late stage drug development for small molecules and biologics, in multiple therapeutic areas.

This position will be responsible for initiating and setting goals for programs according to the strategic objectives of the client, as well as plannig the programs from start to completion involving deadlines, milestones and processes, approving budgets and timelines.

This role is a highly skilled professional with extensive experience in regulatory requirements during drug development and in-depth knowledge of the therapeutic area, enabling them to offer scientific and strategic guidance to drug development teams.

The Director of Regulatory Affairs will be accountable for delivery of regulatory affairs for the product portfolio, both strategy and operations. This role will need to provide key input into non-clinical and clinical aspects of regulatory preparation, delivering a regulatory strategy for novel therapeutics in oncology and autoimmune disease areas.

The Director of Regulatory Affairs will be accountable for delivery of regulatory affairs for the product portfolio, both strategy and operations. This role will need to provide key input into non-clinical and clinical aspects of regulatory preparation, delivering a regulatory strategy for novel therapeutics in oncology and autoimmune disease areas.

This individual is responsible for internal/external technology transfers and manufacturing support covering Upstream (USP), Downstream (DSP) and Fill&Finish (F&F) process. As a Subject Matter Expert of MS&T, you will provide advice and guidance on manufacturing technology issues, initiatives and strategy for continuously improving manufacturing performance.

As part of the Program Management Team, the Project Manager will lead as a technical liaison with the internal team and biotechnology clients. This key role will be highly visible within the organization and will support the company in achieving sales and operations objectives, as well as support our client's goals and objectives.

This role ensures and promotes compliance through the management of external auditing of suppliers, vendors, service providers and manufacturers based on ISO 9001 Standard.

Maintain a risk-based auditing program supporting supplier qualification initiatives, continuous improvement and regulatory compliance across all sites. Represent as the key Supplier Quality Champion.

This role ensures and promotes compliance through the management of external auditing of suppliers, vendors, service providers and manufacturers based on ISO 9001 Standard.

Maintain a risk-based auditing program supporting supplier qualification initiatives, continuous improvement and regulatory compliance across all sites. Represent as the key Supplier Quality Champion.

Seeking a Principal Associate Scientist to shape the Downstream Process Development strategy.

Now seeking an Principal/Associate Scientist for Analytical Development- Protein Mass Spectrometry for our client, a leading CDMO.

This individual will manage cross-functional project teams in all elements of the design, development and completion of the company's portfolio of large capital projects. Elements include scope definition and control, stakeholder alignment, project planning, resource and risk management, project leadership, and team development and communication.

As a key member of facility leadership team, the Director of Engineering and Facility Management is responsible for working with Site/Division leadership and Global Engineering leadership to lead the execution part of the facility engineering design and construction/validation activities.

This position provides high-quality technical environmental, health, safety, and managerial support to our Client's facilities. This role places a strong emphasis on providing high-quality technical support to facilities in the establishment of sustainable EHS management systems, programs, and processes.

The Workplace Services Manager is responsible to managing all our Client's offices aesthetics, operations, and maintenance activities, partnering with both internal and external stakeholders to ensure our employees have no environmental impediments to the prosecution of their duties.

Setting up manufacturing sites (including development and implementation of QMS) to support full product life-cycle.

Adhere to cGMP and ISO standards.

QMS Managers create and monitor quality processes to ensure that equipment, instruments, and people produce products and services in accordance with company and industry regulatory requirements. The role, within an innovative combination medical device company, provides clear quality guidance by ensuring clear policies, procedures, instructions, forms, and objectives are provided.

The Facilities Manager will manage all company's offices aesthetics, operations, and maintenance activities, partnering with both internal and external stakeholders to ensure our employees have no environmental impediments to the prosecution of their duties.

The EHS Specialist will provide high-quality technical environmental, health, safety, and managerial support to the company facilities. This individual will support company sites in the establishment of sustainable EHS management systems, programs, and processes that promote a culture of EHS excellence.

The Quality Assurance Associate II will report directly to the QA Lead or Director.

The Senior Director of Quality must have a good understanding of quality systems to meet applicable requirements of cGMP and ISO standards, particularly 21 CFR Part 820, 21 CFR Part 210/211 and ISO 13485.

The Sr/ Principal Scientist will be responsible for developing bioanalytical assays for antibody therapeutics or other large molecules in a start-up environment. This position will address bioanalytical challenges associated with the measurement of large and small molecules in complex matrices, through the management of work at external partners as well as in-house assay development.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for the Quality review of manufacturing production records, including verification of raw materials used, verification of calculations and critical process steps, and evaluation of Quality Control testing.

QA Associate

The QA Director manages cGMP activities and its required documentation, and leads the Quality Team to successfully support Operations to meet scheduled activities while maintaining compliance.