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DIRECTOR, TECHNICAL OPERATIONS VALIDATION LEAD- CELL THERAPY

Create, maintain, deploy global Cell Therapy validation technical standards via quality system. Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to Cell Therapy...

CompanyBiospace
AddressDevens, MA
CategoryInformation Technology
Job typeConsultant
Date Posted a month ago See detail

Director, Technical Operations Validation Lead- Cell Therapy

Biospace

Devens, MA

Create, maintain, deploy global Cell Therapy validation technical standards via quality system. Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to Cell Therapy...

Director, Technology Transfer, Analytical & Process Implementations- Cell Therapy

Biospace

Devens, MA

Lead and Interface with manufacturing site operations teams and process/analytical SMEs to implement processes, procedures, and analytics by applying in-depth CAR-T manufacturing process knowledge. Promote innovative and efficient...

Associate Director, Quality Engineering, Cell Therapy

Biospace

Devens, MA

Directs the QA oversight of commissioning, qualification, and validation activities required for Cell Therapy manufacturing facility, technology transfer, and product launches. Leads team responsible for QA review and approval and...

Associate Director, Quality Product Lead

Biospace

Devens, MA

Serve as the core Quality member of the global Operations team (GO) as the single point of contact for the commercial brand, responsible and accountable to the brand team for overall success against the strategic plan (lifecycle,...

Associate Director, Supplier Relationship Manager, Cell Therapy External Manufacturing

Biospace

Devens, MA

Responsible for overall supplier governance for vendors within remit. Develops and maintains strong strategic relationships with the CMOs to ensure the best outcomes for BMS Cell Therapy assets, both short and long-term. Leads vir...

Associate Director, Quality Engineering, Cell Therapy

Biospace

Devens, MA

Directs the QA oversight of commissioning, qualification, and validation activities required for Cell Therapy manufacturing facility, technology transfer, and product launches. Leads team responsible for QA review and approval and...

Account Director II

Lumen Technologies

WOBURN, MA

Develops and manages relationships with acquired and/or existing customers in order to gain strategic positioning with decision makers, attain additional business, and retain existing revenue. Develops action plans to cross-sell a...

Director of National Quality Management

Elevance Health

WOBURN, MA

Develops, implements, and leads an industry leading quality improvement program for the Wellpoint product in Massachusetts ensuring that all performance guarantee metrics and client requirements are met and/or exceeded. Designs, a...

Associate Director, Translational PKPD

Astrazeneca

Waltham, MA

$195K - $247K a year

PhD in a discipline with a significant component of analysis and quantitation, such as pharmaceutical sciences, quantitative pharmacology, pharmacometrics, engineering, physics, or applied mathematics, with a minimum of 2 publicat...

Associate Director, Field Medical

Sobi

Waltham, MA

$207K - $262K a year

Competitive compensation for your work Generous time off policy Summer Fridays Opportunity to broaden your horizons by attending popular conferences Emphasis on work/life balance Collaborative and team-oriented environment Making...

FAST Labs - Microelectronics Product Line Technical Director

Bae Systems

Nashua, NH

Active DoD Secret clearance, ability to obtain TS/SCI and SAP clearances. Bachelor's Degree with 15+ years of experience in technology maturation and transition. 4+ years experience in managing or leading microelectronics technolo...

Associate Director, Clinical Scientist

Biospace

Waltham, MA

In collaboration with the Clinical Development Lead, be accountable for the scientific aspects of the design, implementation, and conduct of clinical trials with both internal and external stakeholders (e.g., investigator meeting...

Director, Global Medical Affairs Lead

Biospace

Waltham, MA

Serve as a medical subject matter expert on ASOs and other therapeutic modalities for our NMD programs. Serve as internal expert on medical literature / data associated with our NMD programs. Represent GMA on cross-functional team...

Regulatory Affairs Director, Oncology

Astrazeneca

Waltham, MA

Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.. Develop and implement the program's regional or global strategy ensuring tha...

Associate Director (Animal Sciences & Technologies)

Astrazeneca

Waltham, MA

BS degree in biology or related field is required, an advanced degree (PhD or DVM/VMD) is preferred.. 5+ years of experience in laboratory animal science or specialty certification. In vivo skills in a variety of animal species. E...

Supply Chain Planning Director (Hybrid)

Bae Systems

Hudson, NH

Demonstrated ability to collaborate with key stakeholders and subject matter experts to yield total Supply Chain solutions Excellent relationship / interpersonal skills ; demonstrated ability to foster and grow relationships. Exce...

Senior Director, Clinical Operations Program Lead

Biospace

Waltham, MA

Leads the development and ongoing refinement of Program level study timelines and scenariosin order to contribute to the CDP, IDP and other high-level strategic plans. Provide rigorous, objective information (operational status...

Associate Director, Clinical Data Analyst

Biospace

Waltham, MA

Coordinate with data management study leads, clinical operations, internal stakeholders and external vendors to map non-EDC data from collection through analysis. Partner with IT, internal functions and external vendors to develo...

Associate Director, Clinical Operations Study Lead

Biospace

Waltham, MA

Manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations. Develop study level ope...

Director, Communications

Thermo Fisher Scientific

Waltham, MA

8+ years of communications experience in corporate communications, marketing communications or public relations. Experience in driving internal and external communications strategies, including change communications. Expert writer...

Associate Director, Statistical Programming

Biospace

Waltham, MA

Lead and manage the Statistical Programming activities for clinical trials and studies, ensuring high-quality deliverables and adherence to timelines. Collaborate with biostatisticians, data managers, and cross-functional teams to...

Senior Director, Translational Medicine, R&D Oncology

Astrazeneca

Waltham, MA

Leadership of biomarker strategies for a portfolio of clinical trials within the IO portfolio. Through the analysis of patient samples, using the best available science and technologies, derive insights that guide indication selec...

Senior Director, Regulatory Information Management

Biospace

Waltham, MA

Develop and implement the strategy for Regulatory Information Management including processes and optimization of systems. Develop and implement the strategy for operationalizing simultaneous marketing application filings in multip...

Staff Vice President, Investment Accounting

Factory Mutual Global

Waltham, MA

Work with other units, including foreign affiliates, to determine required reporting, procedures and controls necessary to provide any new financial reporting and analysis on investments, cash flow and the pension and postretireme...

Executive Director, Hematology Discovery R&D

Astrazeneca

Waltham, MA

Hematology is central to our strategy and vision for AstraZeneca's becoming the leading company in the discovery and development of innovative medicines for cancer patients. The candidate should be innovative, self-motivated, coll...

Director NE FP&A

National Grid

Waltham, MA

About usNational Grid is hiring a Director, New England FP&A for our CFO function in Waltham, MA.Every day we deliver safe and secure energy to homes, communities, and businesses. This requires us to deliver on our promises and al...

Finance and Administration Director, USAID/Global Resilience Against Drug-Resistant Tuberculosis

Management Sciences For Health

Medford, MA

Management Sciences for Health (MSH) saves lives and improves health by helping public and private organizations throughout the world to effectively manage people, medicines, money, and information. Working from more than 30 count...

Finance Operations Director

Thermofisher

Waltham, MA

In addition, the position holder will provide valuable decision support, identify and implement operational improvement opportunities and develop a strong finance team.What You Will Do:Drive AOP / QBR / STRAP, in a matrixed financ...

Senior Director, Translational Biomarkers

Biospace

Waltham, MA

Develop experimental and translational medicine study designs to evaluate disease heterogeneity, mechanism of action for disease treatment or prevention. Develop a biomarker strategy to support clinical development for early-stage...

Medical Director

Cogent Biosciences

Remote - Waltham, MA

$270,000 - $315-000

Work closely with Cogents research teams to provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives as required. Provide medical expertise to assess the clini...