
Senior Manager Pdp Development
Há 4 dias
RBW Consulting are partnered with a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defence mechanisms and eliminate these cells. They have a pipeline of product candidates in development for the treatment of haematological malignancies and solid tumours.
Role overview : The Senior Manager - Tissue Operations is accountable for managing onboarding and on-going performance of Apheresis and Treatment Centres used for Clinical CAR-T therapies. This role serves as the technical operations single point of contact for Apheresis and Treatment Centres within the designated region and may require management of contract employees. This role is remotely based to service designated regions, with regional travel up to 75% of time.
Key Responsibilities
- Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for the assigned region.
- Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support clinical trial site plans for the region.
- Coordinate onboarding activities with internal teams and collection site staff to ensure sites are prepared for collections within required timelines.
- Communicate onboarding status to Clinical teams and develop mitigation plans for delays.
- Perform technical site assessments and train collection center staff on collection requirements; attend site audits as required. Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
- Monitor vendor performance and capacity after site launch with QA and other internal partners.
- Manage rollout of process changes to assigned sites; collect VOC and VOB feedback for continuous improvement.
- Collect and enter data into electronic data management systems; represent the department on cross-functional project teams as requested.
- Comply with applicable SOPs and regulations.
Demonstrated skills and competencies
P – Preferred
Experience
- Experience in Apheresis Operations Management, QA Operations, GMP production, GTP or related operational areas; regulated (GxP) environment; understanding of HTA.
- Experience in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
- Experience with critical raw material suppliers or contract manufacturing organizations.
- Operational role for supplier qualification and management of external apheresis or cellular therapy programs.
- Experience in a team-based environment and delivering process improvements for external cell procurement suppliers.
- Experience managing contracts with external apheresis providers and prior customer-facing roles in the pharmaceutical/biotech industry.
Qualifications
- Undergraduate degree in related science or nursing; advanced degree preferred. Be fluent in English and Portuguese.
Skills / Specialist knowledge
- Problem solving, organizational ability, medical/scientific knowledge, regulatory awareness, attention to detail, multi-tasking, customer-centric mindset, and strong interpersonal/presentation skills across cultures.
Application
Please apply here and a recruiter will be in touch to discuss your application further.
Senior Project Manager (Software Development)Job Title: Senior Project Manager (Software Development)
Type: Full-Time
Indigo Beam is a digital transformation consulting firm dedicated to helping organizations evolve their business through modern technology solutions. We partner with clients to improve customer experience, reengineer operational workflows, modernize legacy systems, and unlock data-driven insights. Our services span Content Management, ERP, Digital Modernization, GIS & BI, CRM, and AI.
Key Responsibilities :
Leadership & Team Management
- Lead and manage cross-functional teams, including Technical Architects, Developers, QA, and Business Analysts; ensure high performance and alignment with project goals.
- Provide mentorship and guidance to team members; foster collaboration and innovation.
- Oversee daily operations to ensure tasks are completed on time and within scope.
Project Management
- Develop, maintain, and execute detailed project plans, schedules and budgets; deliver projects on time, within budget, and to quality standards.
- Manage multiple software development projects; own and facilitate project status meetings.
Microsoft DevOps Project Management
- Manage sprints, backlogs, and work items in Microsoft DevOps; track user stories and epics; facilitate stand-ups, planning and retrospectives; monitor progress using Agile metrics.
- Ensure DevOps practices support efficient project execution and client alignment.
Business Analysis
- Gather requirements, map processes, and conduct stakeholder interviews; ensure requirements are clearly defined and communicated.
Client Engagement
- Serve as primary client contact; communicate progress, risks and issues; ensure client satisfaction.
Technical Oversight
- Collaborate with Technical Architects; review/approve documentation; stay updated on industry trends for strategic direction.
Quality Assurance & Risk Management
- Implement quality control; identify and mitigate risks; provide proactive solutions.
Required Skills & Experience
- Bachelor's degree in IT, CS, Business or related field.
- Minimum 8 years IT Project Management in an Agile (Scrum) environment focusing on application/software development.
- Hands-on development experience; proven leadership of cross-functional teams.
- Experience with Microsoft DevOps; managing user stories, epics, sprints and Agile metrics.
- SDLC oversight from requirements to deployment.
- Strong communication, leadership and organizational skills.
Desired Skills & Qualifications
- Experience in Oil & Gas industry; consulting mindset; PMP and CSM certifications.
Other
- Dynamic work environment with cutting-edge technologies; proactive and detail-oriented candidate needed.
Informations
- Type of Contract: PJ
- Hours: Full-time
- Location: 100% Remote
- Start Date: Immediate
- Duration: Long-term
Note: All content reflects roles and responsibilities as described; no translations or invented facts. This refined description retains core job information and presents it in a structured, standards-compliant format.
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