QA Associate

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.

This is a high growth opportunity within a HealthTech start-up company. They are looking for a Senior DevOps Engineer to take ownership of their NYC DevOps team and own their technology platform. This is one of the first DevOps hires.

The individual will be part of a team responsible for supporting GMP medicines.

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.

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.

The Project Manager will be a key member of the Project Management team, overseeing internal and external projects. The Project Manager will lead and own the project from initiation through completion. The role will be highly visible within the organization and will support the company's and client's goals and objectives.

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 cell/gene therapy manufacturing space. Establish strong internal and client relationships while working across team functions.

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

Adhere to cGMP and ISO standards.

This individual will be responsible for representing Regulatory Affairs in cross-disciplinary project teams, developing regulatory strategies for assigned program(s), and managing high-quality submissions to regulatory agencies.

Generate, expand, and transfer new production processes to support late stage drug development. Work cross functionally and lead other scientists and engineers to accomplish these goals.

The MSAT Engineer is responsible for ensuring tech transfer and technical support for cGMP manufacturing among other responsibilities. This individual will ensure all aspects of technology transfer and technical support are successfully executed and provide Engineering support for process equipment.

The Sr Engineer is responsible for ensuring tech transfer and technical support of large-scale mRNA and lipid nanoparticle platform and buffer manufacturing in cGMP Manufacturing. This individual will ensure all aspects of technology transfer and technical support are successfully executed and provide Engineering support for process equipment.

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

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.

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 the "COO of the asset," the Associate Director of Program Management will build and maintain complex project plans and budgets from pre-clinical activities through launch and commercialization for the company's lead drug/therapies. This individual will be tasked with managing pre-clinical and clinical stage programs in a start-up style of environment.

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.

Reporting to Senior Leadership, the PBPK Group Leader will lead the PBPK modeling team in the translational medicine department. This individual will own 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.

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

The Project Manager will be a key member of the Project Management team, overseeing internal and external projects. The Project Manager will lead and own the project from initiation through completion. The role will be highly visible within the organization and will support the company's and client's goals and objectives.

The Bioassay Quality Control Specialist will be responsible for supporting bioassay method transfer, qualification, GMP release testing, investigations and troubleshooting for QC raw material, drug substance and finished product for products produced at the GMP manufacturing facility and affiliated contract organizations.

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.

Work closely with VP of Quality and executive team to develop Quality requirements defined by the strategy and direction of the company. Executes plans to meet its stated objectives. Responsibilities include Director level management of QC and QA departments. Role will assist Quality teams for audit preparation for successful registration and certification, and continual compliance to FDA Regulations, CE EU Medical IVD Regulations, and ISO 13485 Standards.

The R&D Manager is responsible for setting clear expectations for direct reports and establishing roles and responsibilities to manage deliverables to meet business commitments. Must possess a true passion for team development, serving as technical lead while coaching their team members. Ideal candidate will develop a strong network across functions, challenge people and project teams to successfully achieve goals while influencing all levels in the org.

The Process Engineer II's role is viewed as an extension of management and responsibilities are broad and include safety, product quality, process control, productivity improvement, and development of a LEAN culture. The Engineer is expected to spend a significant amount of time on the floor, lead major process equipment projects, and mentor less experienced engineers.

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 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 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.