regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units... project teams, and internal/external functional business units as needed. - Works collaboratively with members of the global...
/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills... on or ahead of schedule. Escalate issues that require management review as well as highlight team successes to the wider...
). Strong organization and project management across multiple parallel efforts. Sound judgment with sensitive information; consistent... in radiopharmaceuticals. Role Summary The Associate Director, Search & Evaluation and Alliance Management supports RayzeBio’s external...
and project management software Understanding of activities related to the CMC development of biopharmaceuticals Advanced... and project teams in a timely manner Support product team (PDM subteam and/or CMC) needs for the selection of external service...
and ensure integrated project planning across CMC and development network groups. Foster an environment of agility, resilience... across teams. Qualifications & Experience 7+ years of experience in program/project management within biopharmaceutical R...
ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management...Job Description Summary The Engineering Manager – Ceramic Matrix Composites Design Sub-Section, Defense & Systems...
filings (e.g., IND, CTA, BLA), CMC sections, and inspection support. 4. Project & Program Management Manage multiple... in a culturally sensitive manner with both individuals and groups from diverse backgrounds. Strong project and time management skills...
, and overall plans to Project/Program Teams and senior management Outstanding communication skills (verbal and written... clinic using our innovative manufacturing approach to cell and gene therapies. As the Senior Manager Regulatory Affairs...
Job Overview Our client in Boston MA is a biotechnology company that is looking a Regulatory Affairs Manager/Senior... molecules, or gene/cell therapies. Proficient in oral and written communication Great project management and organizational...
analysis, presentation, facilitation, and project management skills Exceptional communication, leadership, and relationship...it's what's inside that counts There's more to CMC than our products and the buildings, structures, and roads...
covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.... Job Description: The role of the Senior BD is to drive and support sales efforts in a given territory by implementing the sales/marketing...
. This position will interface with Clinical, Project Management, Regulatory, QA, Manufacturing and teams. The Senior Specialist... in Drug Product Manufacturing activities, project management, planning, budgeting, managing third party vendors and timely...
, Program Team Leadership (direct manager), and the Chief Medical Officer (through reporting structure) and works with senior... governance bodies including R&D Forum and Management Committee to drive key program decisions. This position attracts senior...
Job Description General Summary: We are seeking an accomplished and strategic leader to serve as Senior Research... Fellow, DMPK Project Lead to guide the DMPK strategy for our Biotherapeutics portfolio including protein, antibody, ADC...
. Process Development Senior Scientist What you will do Let’s do this. Let’s change the world. Amgen’s Commercial Attribute... responsible for analytical leadership of large molecule commercial programs and patient impact expansion/lifecycle management...
and effectively communicate and collaborate with senior management stakeholders both internally and externally. Proven ability... with external manufacturing partners (CMOs and CDMOs) and Product Supply Management including Clinical Supply Chain management...
requirements, and/or compliance risks for senior management, and/or Committees/Boards or Executives as required. Assist is the... 7, 63, 24 a plus. Strong communication, critical thinking, relationship management, and project management skills...
of Quality contact for new product introduction and PAI readiness for the assigned product(s) on the CMC product and/or project... to critically review product strategy, promoting a risk-based approach. Act as a project manager within Quality for the assigned...
with project management and other technical leaders to execute complex tech transfer challenges across sites, including... medicines to those who need them, improve the understanding and management of disease, and give back to our communities through...
strong administrative, project management, organizational, interpersonal, and communication skills. Responsible for Program Engineering RTX..., and continuous improvement goals. What You Will Do: Leads and directs site-based AMF Program Engineering Senior Managers, Carbon...