The Quality Control Analyst plays a vital role in the environmental monitoring of clinical manufacturing aseptic processes, sterility and lot release testing, and purified water testing while also preparing the Quality Control processes for commercial launch.
- Work with cutting edge technology focused on retinal disease
- Exciting opportunity to grow rapidly growing Quality Control function
Develop and maintain effective working relationships with key stakeholders/functional heads, gaining acceptance of proposals, changes and decisions. Take responsibility for preparing the Integrated Strategic Development Plan.
- Take ownership, control, & responsibility of multiple cross functional projects
- Contribute to the development of T-Cell Therapies for autoimmune diseases
The Quality Control Analyst will play a vital role on the team working in environmental monitoring and aseptic processing.
- Opportunity to drive quality function on a growing team
- Join a highly innovated and focused biotech company
Sr. Manager, GMP QA will manage QA activities and manufacturing. The Sr. Manager will partner with external CDMOs to ensure quality and safety of products.
- Join a publicly traded biotech company
- Help grow quality functions in a rapidly growing company
Perform tasks necessary to coordinate diverse activities and enable the start of patient registry. Help identify the most appropriate vendors for providing the specialized components for the registry database.
- Join a non-profit company of critical importance to the Lupus community
- Expedite scientific discovery and clinical development to transform Lupus care
Lead and manage computation chemistry effort to support on-going new projects. Track record of scientific achievements.
- Complex role to lead structure based drug design expertise
- Drug Discovery start-up in pre-clinical stages with significant funding
The Design Quality Assurance Engineer II will be responsible for providing Quality Engineering support and providing direction in the areas of Design Controls & Risk Management.
- Join a highly disruptive and innovative Life Sciences organization
- Drive product development and design in brand new product line
As the Chief Executive hire in the company, this individual will lead the company to execute its current drug development programs, manage operating expense to ensure investor's investment is used effectively and productively, and lead the team to build a robust pipeline in immune-oncology space, building upon current technology and by acquiring new ones.
- Executive leadership role to advance company's key therapies and pipeline.
- Late-staged biotech startup in the immunology space with sites based in CA & NJ.
As the Chief Executive hire in the company, this individual will lead the company to execute its current drug development programs, manage operating expense to ensure investor's investment is used effectively and productively, and lead the team to build a robust pipeline in immune-oncology space, building upon current technology and by acquiring new ones.
- Executive leadership role to advance company's key therapies and pipeline.
- Late-staged biotech startup in the immunology space with sites based in CA & NJ.
The Sr. GMP Quality Assurance Manager will manage QA activities in the manufacture and disposition of Investigational Product for use in Global Clinical Trials. This role will be a key member of the quality team to assist in the development of a phase-appropriate Quality Management System and work with key stakeholders to achieve continuous compliance in GxP operations.
- Join publicly traded clinical biotech company
- Opportunity to drive Quality function at rapidly growing biotech
The Director of Business Development will provide operational support for the Business Development/Sales objectives for the Business Development Team. Serve as a key member of the Business Development Team in evaluating, recommending and assisting in communication of comapny's Value Proposition to support the BD team in negotiating/securing value-added business opportunities.
- Highly visible role, supporting internal/external projects & meeting objectives
- CDMO w/decades of biopharma industry experience & state-of-the-art facilities
Reporting to the SVP of Business Development, the Director of Business Development Transactions will provide expertise for all transaction efforts including Search & Evaluation, In-licensing, Out-licensing, M&A, and Alliance Management. This individual enables regional opportunities, commercial partnerships, clinical trial collaborations, and M&A.
- Global clinical-staged biotechnology company with a growing presence in the US.
- Stellar pipeline primarily focused on vaccines and oncology.
The Microbiology Research Associate will join the R&D team working closely with an interdisciplinary team to develop and implement microbiology and molecular biology techniques and concepts.
- Exciting opportunity to drive R&D at innovative agriculture tech start up
- Join passionate company focused on improving environmental impact
Provide mentor-ship for junior scientists & engineers. Will be expected to have specialized knowledge of the drug substance and drug product process in order to influence the direction of associated analytical control strategies.
- Head role, responsible for developing cell-based assays and managing team
- Drug Discovery start-up in RI within Cell Therapy space; lead program in Phase 3
This role will be a key member of the Quality Control leadership team, managing the development and approval of their clients' clinical development programs in support of commercial operations.
- Oversee the build up of brand new team and facility
- Join a rapidly growing CDMO company
This role is accountable for quality oversight of facility commissioning, qualification and validation activities at the Marlborough manufacturing plant. This is an exciting opportunity to oversee the start-up of a new manufacturing facility as well as build a team and culture from the ground up.
- Exciting opportunity to build a team and culture from the ground up
- Join a next generation company looking to change the future of medicine
Reporting to the Head of QA, the Sr. Manager of GMP Quality Assurance will manage QA activities related to the manufacture and disposition in the company's products and clinical trials. This individual will partner with CMC, Clinical Supply Management, Regulatory, and external manufacturers to ensure cGMP compliance in products, procedures, and systems.
- Help develop first-in-class oncology therapeutics
- Join a passionate and innovative company looking to make a difference
Plan and execute process characterization studies using statistical analysis and Design of Experiments. Draft and execute process verification and validation protocol and reports.
- Develop new or improve existing processes for immunoassay reagent manufacturing
- Work cross-functionally in a fast paced growing environment
The Research Associate in this role will be involved in many aspects of producing and developing bio-materials, including the analysis, production, isolation, purification and testing of bio-materials within well-defined guidelines.
- Opportunity to work with unmatched scientific technology
- Competitive base salary and bosnus structure
As the VP, Global Quality Assurance, you will lead global QA strategy and be responsible to developing, maintaining and communicating all quality programs throughout the organization. You will install and maintain a culture of excellence across all divisions of the group and ensure all international regulations and industry standards are adhered to.
- Global pharmaceutical organization
- Rapidly expanding organization
The individual will build and lead multiple technical teams to deliver the objectives of the function across the site organization. The Technology lead will foster an environment that encourages innovation and continuous improvement.
- First-of-its-kind biopharmaceutical manufacturing and technology company
- Opportunity to build and lead multiple technical teams
Will be responsible for managing and coordinating all aspects of the Drug Product operations based on the production schedule. Required to demonstrate leadership in manufacturing through leading and developing teams.
- First-of-its-kind biopharmaceutical manufacturing and technology company
- Exciting opportunity to contribute to buildout + qualification of a new facility
Identify and implement process improvements by thinking critically about the execution of all experiments. Regularly present data and findings to technical teams for discussion. Author test methods, study protocols and technical reports.
- Opportunity to join and help build brand new process development team
- Join quickly scaling biotech organization with massive growth opportunity
Provide mentor-ship for junior scientists & engineers. Will be expected to have specialized knowledge of the drug substance and drug product process in order to influence the direction of associated analytical control strategies.
- Head role, responsible for developing cell-based assays and managing team
- Drug Discovery start-up in RI within Cell Therapy space; lead program in Phase 3
Develop fermentation processes including process optimization and scale up. Setup and operate fermentation processes using small scale bioreactors.
- Develop sustainable and biological solutions for modern agriculture
- Develop fermentation processes at the bench with large scale bioreactors
Manage a team and report to the SVP Corporate Strategy and Business Development. Perform scientific and commercial assessments across therapeutic areas.
- Directs Portfolio Strategy and BD for Oncology & Vaccines areas globally.
- Global clinical-staged biotechnology company with a growing presence in the US.
Expected to execute tech transfer into CMOs and provide technical support of cGMP manufacturing at CMOs. Support growth of small molecule production capabilities by transferring processes from lab to GMP production and to larger scale CMO.
- Cutting edge biopharmaceutical company in extreme growth mode
- Support and execute Small Molecule Manufacturing efforts
Will be expected to lead cGMP technical activities including change management, manufacturing deviation investigation, and continual improvement. Also responsible for supporting Tech Transfer projects including coordination of process information exchange, documentation of tech transfer and tracking process performance.
- Cutting edge biopharmaceutical company in extreme growth mode
- Execute tech transfers and provide support of plasmid production platform
We are looking for an experienced and motivated candidate to join our Process Development team. The successful candidate will work to develop test methods or processes in a high-volume manufacturing environment.
- Opportunity to join and help build brand new process development team
- Join quickly scaling biotech organization with massive growth opportunity
The Project Manager will lead and have overall responsibility for the project from project initiation through completion. 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.
- Highly visible role, supporting internal/external projects & meeting objectives
- CDMO w/decades of biopharma industry experience & state-of-the-art facilities
