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This client is seeking a technically accomplished scientist with a thorough understanding of Biologics/Cell Gene therapy related assays and technology. Reporting to the CEO, this role will have responsibility for the oversight of Analytical QC operations. The role will be of high visibility and expected to partner with Analytical Development, Quality Assurance and Manufacturing in supporting operational needs for the site.
The role will have full control to strategies, plan and execute the companies' clinical assets in oncology and diseases with budget and direct line responsibility for patient advocacy, medical affairs, and clinical operations. This role will play a pivotal role in building the companies future vision with full access to the board.
We are looking for an exceptional Senior Director, Clinical QA to join our team and manage clinical, laboratory and pharmacovigilance quality assurance. This role will manage all GCP, GLP and GVP quality oversight as it relates to the client's phase I, II and III clinical studies.
This position will be primarily responsible for generating revenues and sales for drug discovery R&D business in the target markets / segments in the USA. The position will be our front face to customer and will be expected to build a strong network of global clients in the above domain through close interaction with senior level contacts in the relevant industries and delivery of differentiated customer services.
A competent and seasoned business development (BD) executive is presently being sought to join and be a leader on the BD team. This job provides fascinating opportunity to research and examine the global biotech and pharmaceutical industries' competitive environments. The worldwide business development initiatives will be spearheaded by this candidate.
This Executive Director / Head of Clinical Operations will lead psychiatric programs. Highly visible role expected to interact with the executive team, design Clinical Studies, and build and manage CRO relationships.
Ideally, candidates are to have 15+ years of experience managing clinical trials execution in biotech / pharma and experience in CNS or psychiatric programs is preferred.
The position will be our front face to customer and will be expected to build a strong network of global clients in the above domain through close interaction with senior level contacts in the relevant industries and delivery of differentiated customer services.
This customer-facing role conveys the value offer comprised of our small molecule manufacturing capabilities, process R&D, validation, and analytical development.
In this highly visible role, this individual's primary responsibilities are focused on several areas including, but not limited to, design and implementation of clinical studies; building and managing relationships with CROs and academic collaborators; implementation of standard operating procedures for clinical development; contributing to the creation and implementation of the overall clinical strategy of of the business.
Design and implementation of clinical studies; building and managing relationships with Contract Research Organizations (CROs) and academic collaborators. This includes implementation of standard operating procedures for clinical development; contributing to the creation and implementation of the overall clinical strategy.
The Validation Engineer has responsibility for designing and maintaining the validation system and ensuring the appropriate validation policies and procedures are in place within the Quality Management System. The Validation Engineer is responsible for ensuring the equipment, manufacturing and testing facilities and utilities serving the facilities are validated and any re-validation studies are performed.
We are looking for an exceptional Director, Clinical Quality to join our team and manage clinical, laboratory and pharmacovigilance quality assurance. This role will manage all GCP, GLP and GVP quality oversight as it relates to the client's phase I, II and III clinical studies.
Design and develop novel synthetic routes to pharmaceutical APIs in the laboratory and implementing the processes at kilogram-scale in internal facilities. Maintain clear and accurate records of experiments in laboratory notebooks in accordance with company policy and analyze API's and Starting/Raw Materials via HPLC and other analytical methods.
Responsible for the delivery of the qualification programs, ensuring equipment and systems are qualified and in an operational state of compliance associated with cGMP manufacturing environments. Work closely with Engineering / Facilities, Equipment End Users and Quality Assurance to investigate and resolve non-conformances encountered during qualification activities.
The Validation Manager has responsibility for designing and maintaining the validation system and ensuring the appropriate validation policies and procedures are in place within the Quality Management System. The Validation Engineer is responsible for ensuring the equipment, manufacturing and testing facilities and utilities serving the facilities are validated and any re-validation studies are performed.
We are looking to grow business development activities across North America to support our CDMO offerings across the globe. Seeking a confident high-caliber individual with passion and high adaptability to diversity to leverage in our capabilities and enhance the overall revenue. This customer-facing role conveys the value offer comprised of our small molecule manufacturing capabilities, process R&D, validation, and analytical development.
Management of Big Pharma partnerships in the areas of Chemistry, Screening and other discovery-related activities. Build and manage a robust pipeline of partnerships aligned with the company's value creation strategy for customers, based on their current and future product positions.
Build an implement Clinical Development strategy globally. Serve as member of the executive leadership team among other key responsibilities.
The Scientist, Quality Control position will work cross functionally with manufacturing, product engineering, R&D, MSAT, RRP, Quality Assurance and the customer to implement new test methods and processes within Quality Control to successfully test new and existing products, perform routine quality testing, and support manufacturing and quality investigations
The Validation Manager has responsibility for designing and maintaining the validation system and ensuring the appropriate validation policies and procedures are in place within the Quality Management System. The Validation Manager is responsible for ensuring the equipment, manufacturing and testing facilities and utilities serving the facilities are validated and any re-validation studies are performed.
This candidate will be coming from big pharma and will be managing/overseeing the external collaboration.
This is a key role within the Commercial/Business Team with primary function being business development and supporting discussions between Clients and the Scientific/Technical team. The individual will use his/her strong technical/lab work knowledge in the field of large molecules/biologics to understand the Client's challenges and design solutions. The requests can range from R&D through clinical stage and product commercialization.
Design and develop novel synthetic routes to pharmaceutical APIs in the laboratory and implementing the processes at kilogram-scale in internal facilities. Maintain clear and accurate records of experiments in laboratory notebooks in accordance with company policy.
This individual will be leveraging existing relationships and calling on medical oncologists, surgeons, and KOLs. The ideal candidate has extensive experience in Oncology pharmaceutical sales.
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