Senior Expert Technical Development Lead
4 weeks ago
Job Description
As a Senior Expert Technical Development Lead at Novartis, you will be accountable for leading Drug Product-related project activities within the Process Development line unit. Your key responsibilities will include managing a team of project sub-team members, acting as a project manager, and overseeing project activities. You will be responsible for owning the discipline project strategy in alignment with the technical development plan (TDP) and representing the project sub-team discipline in the CMC team as a core member.
Main Responsibilities
- Lead the discipline sub-team, act as a project manager, and be accountable for all project activities within the Process Development line unit.
- Own the discipline project strategy in alignment with the technical development plan (TDP) and represent the project sub-team discipline in the CMC team as a core member.
- Set priorities and objectives within the Process Development sub-team in alignment with the TDP and CMC objectives, and update the CMC team on technical issues, risks, and mitigation strategies.
- Oversee study design, provide guidance to functional leads (FLs), and ensure adherence to project development strategy.
- Track project progress according to defined timelines, identify roadblocks/risks and issues, develop solutions and mitigation plans/scenarios, and proactively report them to respective stakeholders and governance boards.
- Compile and provide financial forecasts for project-specific development activities needed to reach program milestones.
- Manage project-specific compliance aspects (e.g., change notifications, deviations).
- Assess, consolidate, and monitor resource needs and timelines for assigned projects.
- Ensure DP development is compliant with quality principles and cGMP practice.
Requirements
- University degree in biotechnology, pharmaceutical technology or similar discipline.
- Successfully demonstrated at least 5-6 years (BS), 2-4 years (MS) or 0-3 years (PhD) of related experience with cell therapy process development.
- Thorough understanding of cell therapy development processes, good knowledge of state-of-the-art cell therapy technologies & equipment, and knowledge of ATMP-related health authority regulations.
- Project excellence: Navigating through complexity and ambiguity, strong communication & presentation and organization and planning skills, excellent time management and planning abilities; inclusive in a decision-making process, strong leadership skills in a matrix set-up.
- Operational excellence: Demonstrates cross-functional problem-solving, critical data evaluation, continuous improvement mindset; advanced coaching and proven leadership skills.
- Organizational Savvy: Understanding organizational structures, working practices and strategy. Inclusive and collaborative across disciplines and geographies, excellent networking and relationship building.
- Stakeholder engagement: Excellent communication, negotiation, and interpersonal skills. Ability to work in interdisciplinary and cross-cultural teams; confident in managing expectations and conflict management.
- Business mindset: strategic thinking and planning, confident with risk management including quality & safety, resources and budget planning.
- Vision and Purpose: a role model to the functional team for creating a shared purpose; priorities and objectives setting
-
Compliance Expert Lead
6 days ago
Cambridge, Cambridgeshire, United Kingdom Expert Employment Full timeAward-Winning EmployerWe are seeking a seasoned Health and Safety Executive to lead our team in delivering exceptional health and safety outcomes. The successful candidate will have a proven track record in implementing effective risk controls and promoting a culture of safety within an organization.About the Opportunity:This role offers a competitive salary...
-
Senior Software Development Expert
6 days ago
Cambridge, Cambridgeshire, United Kingdom Pico Technology Limited Full timeAbout the RoleWe are seeking an experienced Senior Software Development Expert to join our team at Pico Technology Limited.This is a full-time position, requiring 40 hours of work per week, based in St Neots, Cambridgeshire. The role offers hybrid working options, allowing you to balance office and remote work.Key ResponsibilitiesAs a Senior Software...
-
Senior IFS Technical Solutions Expert
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom CBS butler Full timeCBS Butler is seeking a highly skilled Senior IFS Technical Solutions Expert to join their team. The successful candidate will be responsible for delivering high-quality solutions aligned with business needs, from requirements gathering and technical architecture to development, testing, and deployment.This role requires strong technical knowledge of IFS...
-
Technical Lead for Device Development
6 days ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeWe are MoonLake Immunotherapeutics, a biotech company that aims to transform global healthcare with novel therapies. We offer an exciting opportunity for a Technical Lead for Device Development to join our team.Job DescriptionThe Senior Technical Manager, Device will act as the subject matter expert responsible for all activities related to the development...
-
Senior Engineering Surveyor
6 days ago
Cambridge, Cambridgeshire, United Kingdom First Military Recruitment Ltd Full timeJob Summary:We are seeking a Senior Engineering Surveyor to support our team across all technical work streams, from project initiation to construction. The successful candidate will be responsible for managing teams, developing engineering survey teams, setting out works, sharing expert advice, and providing topographical surveys.About the Role:This is an...
-
Senior Technical Lead
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom undisclosed Full timeRole OverviewWe are seeking a highly experienced Senior Technical Lead to join our team.As a key member of our engineering team, you will be responsible for leading the development of engineering approaches and strategies.Develop and implement business strategies to drive operational excellence.Manage planning, budgeting, solution development, supplier...
-
Cambridge, Cambridgeshire, United Kingdom SoCode Limited Full timeSoCode Limited is seeking a seasoned Principal Technical Project Manager to drive the development of cutting-edge medical device technology. This senior-level role involves overseeing complex, high-risk projects across multidisciplinary teams.In this position, you will be responsible for managing the full product lifecycle from concept to launch, ensuring...
-
Senior Technical Project Lead
6 days ago
Cambridge, Cambridgeshire, United Kingdom Ecm Selection Full timeWe are Ecm Selection, a leading consultancy firm that provides expert services in Linux systems development, the cloud, and more. As our ideal candidate, you will be responsible for managing a distributed team of software consultants, working with major enterprise clients, and taking a strategic view of commercial endeavors.With a strong background in open...
-
Senior Software Development Lead
6 days ago
Cambridge, Cambridgeshire, United Kingdom Jonathan Lee Recruitment Ltd Full timeWe are working with a leading organisation in the Cambridge area that specialises in mobile communication products, providing radio terminals, accessories, and software applications.The company is looking to hire an experienced Software Architect to focus on embedded, real-time devices. This is a hybrid role with blended flexible working opportunities,...
-
Senior Technical Development Expert
5 days ago
Cambridge, Cambridgeshire, United Kingdom Healthcare Businesswomen's Association Full timeJob OverviewAs a seasoned professional, you will be responsible for leading the development of cell therapy processes and overseeing project activities within the Process Development line unit. With expertise in cell therapy development processes and knowledge of state-of-the-art technologies and equipment, you will ensure compliance with quality principles...
-
Senior Manager Technical Lead
1 month ago
Cambridge, Cambridgeshire, United Kingdom Russell Taylor Group Ltd Full timeRole: Technical Director HorticultureSalary: Competitive (determined by experience)Location: Cambridge - hybrid modelRussell Taylor Group Ltd has an exciting opportunity for a Technical Director within the horticulture industry to join our client's leading household name. Our client is seeking a senior technical professional with experience in new product...
-
Tax Senior Specialist
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Hays Senior Finance Full timeJob OverviewHays Senior Finance is seeking a highly skilled Tax Senior Manager to join our dynamic team in Cambridge. As a key member of our advisory services, you will be responsible for delivering exceptional tax solutions to our clients and driving business growth.About the RoleThis is an exciting opportunity for a senior tax professional to join our team...
-
Technical Solutions Expert
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom ECM Selection (Holdings) Limited Full timeJob SummaryWe are seeking a skilled Technical Solutions Expert to join our team at ECM Selection (Holdings) Limited. As a Technical Support Engineer, you will be responsible for providing expert technical support to our customers, including OEM companies, for mobile phone applications.Located in Cambridge, our company has developed innovative RF-based...
-
Senior Mobile App Development Lead
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Evi Technologies Limited - C67 Full timeEvi Technologies Limited - C67 is looking for a highly skilled Senior Mobile App Development Lead to join our team in Cambridge, GBR.About the RoleWe are seeking an experienced and passionate Android Software Development Engineer who has expertise in building world-class mobile apps. As a Senior Mobile App Development Lead, you will be responsible for...
-
Technical Product Expert
17 hours ago
Cambridge, Cambridgeshire, United Kingdom Illumina Full timeUnlock your potential as a Technical Product ExpertWe are seeking a highly motivated and skilled individual to join our team as a Technical Product Expert at Illumina. In this role, you will be responsible for providing technical expertise and support to customers and internal stakeholders.About the roleYou will have a strong background in molecular biology,...
-
Senior Quality Engineer and CAPA Expert Lead
6 days ago
Cambridge, Cambridgeshire, United Kingdom Philips International Full timeJob OverviewWe are seeking a Senior Quality Engineer to lead our Corrective and Preventive Actions (CAPAs) team. This role will be responsible for ensuring the timely and effective resolution of quality issues, while maintaining compliance with global regulations.About Philips InternationalPhilips International is a leading health technology company...
-
Senior Software Development Engineer
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom ENGINEERINGUK Full timeENGINEERINGUK: Senior Software Development EngineerWe are seeking an experienced Senior Software Development Engineer to join our team of experts in camera software development. As a key member of our team, you will be responsible for designing and developing algorithms and software for our consumer products.Main Responsibilities:Design and develop software...
-
Senior Horticulture Technical Lead
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Russell Taylor Group Ltd Full timeKey Responsibilities:- Lead technical projects in horticulture and agriculture, driving innovation and growth.Requirements:- 3+ years of experience in NPD, preferably in the horticulture/agriculture industry.- Strong technical knowledge and excellent problem-solving skills.- Ability to communicate effectively with cross-functional teams and...
-
Senior Software Development Lead
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Skillsearch Full timeAre you a seasoned software development professional looking for a new challenge in Cambridge? Our client, a leading company in the industry, is seeking a Senior Software Development Engineer to join their dynamic and agile team.Key Responsibilities:Collaborate closely with machine learning experts to drive the direction and design of the company's...
-
Technical Expert for UK Homeland Security
7 days ago
Cambridge, Cambridgeshire, United Kingdom TTP Full timeAbout the Role:We are seeking a highly skilled technical expert to join our team at Awerian, a leading research and development consultancy based in the UK. As a key member of our team, you will be responsible for delivering cutting-edge solutions in the field of cyber security and autonomous systems.Key Responsibilities:Design and develop innovative...