Senior Manager Pdp Development

RBW Consulting are partnered with a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of 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.

The Senior Manager - Tissue Operations is accountable for managing onboarding and on-going performance of Apheresis and Treatment Centres used for Clinical Chimeric Antigen Receptor (CAR) T-cell Therapies. This role will serve as the technical operations single point of contact for Apheresis and Treatment Centres located within the designated region and may require management of contract employees.

This role is remotely based to service designated regions. Regional travel up to 75% of time may be required.

Key Responsibilities

• Develop and foster relationships with Apheresis, Cell Lab and Treatment Centre Staff for assigned region.
• Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support the clinical trial site plans for assigned region.
• Coordinate with internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to perform collections within the required timelines.
• Communicate collection site on-boarding status to Clinical teams and develop and execute mitigation plans for any delayed timelines.
• Perform technical site assessments and train collection center staff on collection requirements and attend site audits as required. Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
• Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
• Manage rollout of process changes to assigned sites. Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations 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 other relevant operational areas. Breadth of experience in regulated (GxP) environment; understanding of HTA (hospital or pharmaceutical/biopharmaceutical company).
• Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs.
• Experience working with critical raw material suppliers or contract manufacturing organizations.
• Experience in an operational role for supplier qualification and management of external Apheresis, Cellular Therapy or Stem Cell Transplant programs.
• Has successfully worked in a team-based environment.
• Experience in delivering process improvements, ideally in processes for qualification, training, and management of external cell procurement (Apheresis) suppliers.
• Experience managing contracts with external apheresis providers.
• Prior customer facing role in pharmaceutical/biotech industry.

Qualifications

• Undergraduate degree in related science or nursing. Advanced degree in related science or nursing is preferred.
• Be fluent in English and Portuguese.

Skills/Specialist knowledge

• Ability to rapidly solve problems and deal with organizational complexity.
• Ability to prioritize and complete work with sense of urgency based on criticality.
• Medical, scientific and clinical knowledge.
• Knowledge of applicable regulations and standards.
• High attention to detail and strong organizational skills with ability to multi-task.
• Customer-centricity—consider the impacts of decisions on the customer while ensuring compliance with regulations.
• Excellent interpersonal and presentation skills to communicate effectively across levels and cultures.

Please apply here and Harry Henson will be in touch to discuss your application further.

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 our clients to improve customer experience, reengineer operational workflows, modernize legacy systems, and unlock data-driven insights that power smarter decision-making. Our services span Content Management, ERP, Digital Modernization, GIS & BI, CRM, and AI—helping businesses not just react to change, but lead it.

Key Responsibilities:

Leadership & Team Management:

• Lead and manage cross-functional teams, including Technical Architects, Developers, QA, and Business Analysts, ensuring high performance and alignment with project goals.
• Provide mentorship and guidance to team members, fostering a collaborative and innovative work environment.
• Oversee the team\'s daily operations, ensuring tasks are completed on time and within scope.

Project Management:

• Develop, maintain, and execute detailed project plans, schedules, and budgets.
• Ensure projects are delivered on time, within budget, and to the highest quality standards.
• Manage multiple projects simultaneously, with a focus on application/software development.
• Own and facilitate project status meetings, adjusting project targets and schedules as needed.

Microsoft DevOps Project Management:

• Manage and configure sprints, backlogs, and work items within Microsoft DevOps to ensure project transparency and alignment with Agile methodologies.
• Track and manage user stories and epics, ensuring they are well-defined, prioritized, and aligned with project goals.
• Facilitate daily stand-ups (scrums), sprint planning, and sprint retrospectives to ensure team collaboration and continuous improvement.
• Monitor and manage burndown charts and other Agile metrics to track project progress and ensure timely delivery.
• Collaborate with team members to ensure DevOps practices support efficient project execution and align with client needs.

Business Analysis:

• Perform business analysis tasks on projects as needed, including requirements gathering, process mapping, and stakeholder interviews.
• Ensure business requirements are clearly defined, documented, and communicated to technical teams.

Client Engagement:

• Serve as clients\' primary point of contact, ensuring their needs and expectations are met.
• Communicate project progress, risks, and issues effectively to clients and stakeholders.
• Ensure client satisfaction by delivering projects that meet or exceed their requirements.

Technical Oversight:

• Collaborate with Technical Architects to ensure project designs align with business objectives and technical standards.
• Review and approve technical and business documentation, ensuring completeness and accuracy.
• Stay updated on industry trends and emerging technologies to provide strategic technical direction.

Quality Assurance & Risk Management:

• Implement quality control processes to ensure deliverables meet the required standards.
• Identify and mitigate project risks, ensuring proactive solutions to potential challenges.

Required Skills & Experience:

• Bachelor\'s Degree in Information Technology, Computer Science, Business Administration, or a closely related field.
• Minimum of 8 years of IT Project Management experience in an Agile (Scrum) environment, with a strong focus on application/software development.
• Prior hands-on development or coding experience.
• Proven track record of managing teams of Technical Architects, Developers, QA professionals, and Business Analysts.
• Hands-on experience with Microsoft DevOps, particularly in managing user stories, epics, sprints, and Agile metrics such as burndown charts.
• Ability to perform business analysis on projects, including requirements gathering and process documentation.
• Experience managing project budgets of over $1M and delivering projects on time and within scope.
• Hands-on experience overseeing all phases of the SDLC, from requirements gathering to deployment.
• Exceptional communication skills, both verbal and written, with the ability to convey technical concepts to non-technical stakeholders.
• Strong leadership and team management skills, with a proven ability to motivate and guide cross-functional teams.
• Strong organization skills and mindset.

Desired Skills & Qualifications:

• Experience in the Oil and Gas industry is highly desirable.
• Previous experience in a consulting role or possessing a consultative mindset.
• PMP certification and CSM.

Other:

• The role offers a dynamic work environment with opportunities to work on cutting-edge technologies and solutions.
• The successful candidate will be proactive, detail-oriented, and able to thrive in a fast-paced environment.

Informations:

• Type of Contract: PJ
• Hours: Full-time
• Location: 100% Remote
• Start Date: Immediate
• Duration: Long-term

End of refined description.