The Associate Director/Director of Quality 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. The position provides leadership and support in the development, design, and implementation of cross funtional GMP processes, associated procedures, systems, and policies.
- Join exciting biotech company preparing for an upcoming BLA filing
- Work on innovative biological drug device combination technology
Oversee and support quality management systems, production operations, ensuring regulatory compliance and continued alignment with the company standards and initiations.
- Join an exciting biotech company treating eye related diseases
- Opportunity to oversee multiple functions on the QA team
The Director, Clinical Affairs, will be a key leadership role responsible for the clinical development strategy and execution of ophthalmic medical device clinical programs. This includes support for all phases of the clinical programs internationally and the United States. The role will lead both clinical development and operations across our programs. Studies for these programs will be in the US and also selectively in other OUS geographies.
- Leadership opportunity with Growing Clinical Start-up
- Support for all phases of the clinical programs internationally and the US
My client, a highly ranked commercial GC, is looking to grow their Preconstruction division. This firm is seeking a Director of Construction who thrives within a leadership position who will make an immediate impact, while providing insight on how to expand their business. If you are interested in an opportunity to further develop your construction career, this is the opportunity for you!
- Strong project pipeline with growth opportunities
- Competitive salary and benefits
The individual in this role will be responsible for the development of analytical methods to characterize both products and to ensure that these methods will be implemented to meet the quality, integrity, and efficiency standards.
- Join a biotech company with an advancing portfolio in viral immunotherapies
- Exciting opportunity to join a fast growing company
You are responsible for developing and executing the supply chain planning process to ensure both clinical & commercial drug product availability based on forecasted requirements. The position also serves as the lead and primary point of contact for all cross-functional activities at the manufacturing sites and ensures contractual commitments are complied with by both parties.
- Manages the relationships and activities with all CMOs
- Help to create a world where no cancer patient ever runs out of options
The Director/Sr Director, Regulatory CMC Biologics will oversee Regulatory Affairs and provide strategic input for CMC team activities for the development of submissions content and strategy for biological and cell and gene therapy products.
- Opportunity to join a high growth, publicly traded biotech organization
- Own Regulatory CMC for diverse portfolio of biologics and CGT products
Exciting opportunity for a seasoned QA leader, who has worked in a clinical trial material/sterile fill-finish pharmaceutical manufacturing and laboratory environment. The Director of QA is responsible for day to day operations and functions as the subject matter expert on the Quality Management System.
- Join an expanding CDMO supporting Phase I, II, & III clinical studies
- Become the QA Head of a highly dynamic team.
Working for this pharmaceutical client in Somerset, NJ you will be leading global internal audit department, including heading up the annual SOX compliance assessment on behalf of management and performing a large range of other audits. As the the Director of Internal Audit you report findings back to VP and CFO of finance as well as audit committee.
- Chance to build out entire Audit Department
- Working for an industry leading health and pharma company
The Director of Quality Assurance will provide leadership and guidance within quality assurance and serve as support for other cross-functional departments.
- Exciting leadership position within QA with high visibility
- Join commercial stage Biotech company with diverse product portfolio
Reporting to the SVP, this individual will cultivate relationships with biotechnology startups, lead as a technical liaison with the customer, and advance BD strategy. This individual will be a hardcore Scientist hired to "speak the science" to end users being heads of drug discovery businesses.
- International CRO seeking Director of BD for growing Discovery group
- Cultivate relationships with biotech startups and lead as technical liaison
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 the organizations Value Proposition to support the BD team in negotiating/securing value-added business opportunities.
- World class CDMO with a focus on cell based therapies seeking Head of BD
- Remote position, can sit anywhere on the East Coast
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 the organizations Value Proposition to support the BD team in negotiating/securing value-added business opportunities.
- World class CDMO with a focus on cell based therapies seeking Head of BD
- Remote position, can sit anywhere on the East Coast
The Global Vice President of Marketing will be responsible for providing strategic direction and tactical oversight of all sales & marketing programs across the organization to promote all services. This position will lead a team of high performing marketing leaders, and exhibit superior competencies in strategic thinking, driving high performance and execution.
- Global, market leading pharmaceutical organization
- Excellent opportunity for career growth
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 the organizations Value Proposition to support the BD team in negotiating/securing value-added business opportunities.
- World class CDMO with a focus on cell based therapies seeking Head of BD
- Fully remote position!
Drive out-licensing efforts for preclinical assets and partnering strategy on AI platform technologies as well as discovery collaboration with external companies. Responsible for scouting, due diligence, negotiation, and execution of BD deals by working closely with our CBO, management, business development, R&D, AI, legal, and finance teams, as well as external parties.
- Fully remote position based anywhere on the East Coast
- Early BD hire directly responsible for expanding the companies strategic growth
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 the organizations Value Proposition to support the BD team in negotiating/securing value-added business opportunities.
- World class cell therapy manufacturer seeking Director of Business Development
- Opportunity to contribute to the development of revolutionary treatment
Lead US supply chain team and coordinate with cross functional teams (including technical, quality, regulatory, business development and marketing) in both US and China to ensure steady drug supply for the global commercial sales. This position can be based remotely with a preference on the east coast (NY, Boston, Maryland)
- Global biologics company focused on oncology, inflammatory and metabolic disease
- Looking for a global supply chain leader with experience in CMO/CRO management
As the VP, Human Resources, you will form part of the executive leadership team, reporting to the CHRO. You will develop and execute the global people strategy to support business growth ambitions. You will define and implement a best-in-class strategy across all aspects of the employee lifecycle including; attraction and selection, diversity & inclusion, learning and development, engagement, performance management, compensation and retention.
- Global, market leading consumer products organization
- Excellent opportunity for career advancement
The Director of Quality 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. The position provides leadership and support in the development, design, and implementation of cross funtional GMP processes, associated procedures, systems, and policies.
- Join an exciting fast-paced clinical stage biotech start up
- Opportunity to grow and develop a highly motivated and talented team
Our client is an established Medical Device Manufacturer that has been in business for over 100 years. They seek a Vice President of Regulatory/Quality that will report to the Executive Vice President.
- Oversee Quality/Regulatory team, established Medical Device Manufacturer
- Incredible benefits, including remote work, bonus and 8% 401k match
Responsible for identifying, developing and executing business opportunities in the pharmaceutical, biotech industries on a global basis to strategically grow the business. Identify viable short and long term business opportunities in the CDMO space including CMC and GMP manufacturing and develop plans to convert opportunities into new business and revenue.
- Global CDMO in small molecule space seeking Sr. Director of Business Development
- Full time remote opportunity!
The VP of Regulatory Affairs will develop and execute the global regulatory strategy for our client's product pipeline and provide strategic leadership to oversee and direct all regulatory activities through early and late stage development.
- Exciting opportunity to build out Regulatory function at high-growth start up
- Own Regulatory aspects of programs approaching the clinic in both US and China
Responsible for efforts across pre-clinical and early development, including pre-clinical pharmacology, transnational science, toxicology and DMPK. Lead a senior, multi-disciplinary team to progress programs from discovery into early clinical development.
- Lead pre-clinical and early development activities
- Join an exciting pre-clinical company with a focus on immuno-oncology
The Director, Regulatory Affairs, CMC is responsible for the submission of INDs, NDAs, BLAs, as well as other regulatory submissions for CMC topics as required in collaboration with appropriate leadership.
- Join a growing biopharma company focused on Oncology
- Great opportunity to oversee a team changing the lives of cancer patients
The Director of Business Development, Bioanalysis will be responsible for generating sales for Bioanalysis throughout North America. This position will also contribute to the overall commercial sales strategies for sales of integrated preclinical and clinical development programs focused in North America.
- Join global CDMO leader with recently launched US Bioanalytical Services group
- Fully remote position with ownership over NA territory
The role requires significant experience and proven success with developing and executing regulatory strategies for complex drug development programs. The Senior Director serves as the regulatory lead for assigned product program teams and will manage other members of the regulatory affairs organization.
- Join a biotech company developing medicines for devastating diseases
- Exciting opportunity to serve as lead of Regulatory
The Director of Business Development, Bioanalysis will be responsible for generating sales for Bioanalysis throughout North America. This position will also contribute to the overall commercial sales strategies for sales of integrated preclinical and clinical development programs focused in North America.
- Join global CDMO leader with recently launched US Bioanalytical Services group
- Fully remote position with ownership over NA region
The Director of Business Development, Biologics will be responsible for both strategic and tactical selling of the Biologics production and manufacturing service portfolio utilizing highly consultative and technical sales strategies. Customers include biotech, pharma and large academic institutions.
- Global leader in drug R&D rapidly growing through expansion and investment
- Fully remote position with ownership over East Coast NA region
Serve as Quality function in this hands-on position overseeing, improving, and implementing the Quality Management System. Provide Quality related training. Coordinate internal and external quality audits. Internal subject matter specialist for regulatory strategy and implementation of filings and maintenance of approvals, trouble shooting, and regulatory authority interaction for product line.
- Leadership opportunity in terrific Medical Device Manufacturer
- Fully remote flexibility
