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As a Biotechnology Recruitment Consultant, you will generate and maintain pipelines of candidates and clients in technical markets. You will be responsible for the whole life cycle of the recruitment process.
The FP&A Manager will be a leading player in global commercial finance for the biotechnology firm. The FP&A Manager will be a part of a larger team and will be a driving force in the development of the current team and future initiatives - including system implementations & personnel hiring. The biotechnology firm is looking for a strong FP&A Manager due to growth and offers great work from home flexibility and a long term home to continuously grow.
The Corporate Controller will lead a growing business unit, and lead the internal team effectively while working cross functionally with other parts of the biotechnology business in Philadelphia, PA. This role will oversee payroll, state tax, all distribution finance, long term financial planning, and international reporting structure/process. This role is open due to growth, and will sit in Philadelphia, PA and will report directly into the CFO & ownership.
Drive and perform regulatory activities linked to development, variations of US/international submissions to meet clients' needs. As a Global regulatory CMC team member, you define the CMC regulatory strategy, and work in close collaboration with clients, internal development and manufacturing colleagues to provide regulatory impact assessments on product/process development, manufacturing, tech transfer, scale-ups or method changes, etc.
Join preclinical research team focusing on in vivo procedures, sample harvesting, and biological analyses. Work cross functionally in dynamic fast paced environment.
Owns the Materials System, ensuring raw material control process and procedures are in compliance with applicable heath authorities' requirements, e.g., FDA, EMA. Update and review procedures as needed working cross-functionally with involved areas.
Serves as lead QA Systems and Operations Subject Matter Expert (SME) for Raw Material Review Board, SCAR program, Exception management programs, and regulatory inspections.
This person will manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics.
This person will lead business development strategy toward licensing, and partnership execution, to accelerate our clinical asset progress. You will establish an ambitious business development plan that integrates into our scientific, strategic and financing plans.
Be a key member of senior leadership team with a high degree of visibility and impact across the organization. Bring a strong strategic mindset and have a proven track record of success in leading a company's technical operations, including process and analytical development, Clinical and Commercial Manufacturing.
They will be working on pharmacology projects to design, create, test and evaluate novel tumor-directed and immuno-oncology-focused therapeutics through close collaboration and interaction with specialized internal teams and external CRO. The successful candidate will present the data to the project team and senior management.
Join the CMC group and help int he development, qualification, and execution of analytical methods and bioassays in support of clinical development of protein therapeutics. Work in cross functional environment and provide support for Process Development and Research and Discovery groups.
Responsible for the development, optimization, and troubleshooting of upstream and/or downstream processes in support of clinical development of company's recombinant protein therapeutics. Work in a high collaborative team, providing support to Research and CMC groups.
This is a highly visible, impactful, and vital position created at the intersection of overlapping areas of Pledge's strategy, operations, and partnerships. The successful candidate is a strategic individual with intuitive intelligence and an entrepreneurial spirit.
Individual sales contributor selling Clinical Saas platforms to clinical/R&D professionals
The QC Sr. Analyst will be responsible for working under guidance of a QC Manager and will support equipment qualification, the inspection and release of various incoming raw materials for use in the manufacturing of cell therapy products, including authoring material specifications, in compliance with all applicable quality systems and current cGMPs. They may also support routine QC lab and testing support activities as needed and will be responsible for analytical method analysis and/or qualification associated with cGMP production of cell therapy products. They will be responsible for writing protocols, standard operating procedures (SOPs), and reports in support of analytical testing.
The Associate Ditector, QC is responsible for providing daily management of microbiology lab operations (people, process, product) within Quality Control. The successful candidate will contribute to testing/reviewing QC data, develop environmental and utility monitoring programs and lead QC Microbiology related activities such as investigations, CAPAs and change controls to assure adherence to regulations and client expectations.
Lead virology therapeutic projects across the discovery and preclinical spectrums. Define the path to drug discovery from hit-generation to candidate selection with compelling data packages in line with our corporate goals.
Lead oncology therapeutic projects across the discovery and preclinical spectrums. Define the path to drug discovery from hit-generation to candidate selection with compelling data packages in line with our corporate goals.
The Quality Assurance Director supports and provides leadership to the Quality Assurance organization in areas of cGMP Operations, Quality Systems, Validation, Inspection Readiness, Supplier Management, Compliance, Auditing, Documentation, and Training. This individual will provide leadership and support in the development, design, and implementation of cross funtional GMP processes, associated procedures, systems, and policies.
The VP of Quality will be responsible for defining the direction for the Quality team and Quality objectives in alignment with corporate and portfolio strategy.
Partner with Program Team Leader to successfully shape and execute drug development strategies. Help develop overall Program Management function.
Improve manufacturing processes while performing technology transfers to internal MS&T team. Work closely with internal colleagues in analytical development and quality control.
This individual is to play a key role in implementing and optimizing processes related to the development of cellular therapies. They will work to optimize cell isolation and culture protocols, develop assays, and integrate cell culture platforms and analytical technologies in a GMP-compliant workflow.
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