Your goals, my passion, my work
I am passionate about your goals and curious to learn about your journey. I am a CMC consultant and I train Project Managers. Read about my work below.
Cases
Enjoying Lean Processes
This case describes how a complicated process for management of vendor change notifications was simplified by using existing tools and got to work smoothly and efficiently
Smooth Projects
Here you can read how I managed the customer-CMO relationship in a complicated project that covered the product life-cycle until process validation
Smart and simple solutions
A case on how an existing risk assessment was adapted so it could be used in a process characterization study to identify potentially critical process parameters
Delivering the project schedule
How to deliver a schedule of the plant start-up activities when milestones of the preceding construction and CQV projects are unknown.
Projects and training
From strain development to successful pre-approval inspection
11 year project with Swiss Biotech company and global pharmaceutical company. The project involved microbial strain design, process development and optimisation, tech transfer and scale-up from lab to pilot production, followed by clinical scale production. After the process was successfully characterized and validated, pre-approval inspection was successful.
Scale-up from 1'000 to 10'000 L scale
Production of clinical phase II material on 1’000 L scale, was followed by successful scale-up to 10’000 L scale. Challenges were the use of large buffer volumes and a high number of different buffers, containing urea and DTT and the limited scaleability of the process (heat treatment and flocculation)
Managing operational startup in greenfield project
Managing the operational start-up activities of Lonza’s 1K/2K NSYNC facility by leading multidisciplinary teams to ensure a timely start of commercial activities. Representing the key interface between Engineering and Operational units to guarantee a smooth operational start-up from commissioning, IQ, OQ, PQ to commercial production.
Interim project management for process characterization and validation
7 month interim assignment to bring back on track, speed up and manage process characterization and validation activities. PC and PV studies were carried out in parallel, requiring extra-ordinary coordination and project risk management. Key was alignment of customer and contractor, establishing a communication plan and making all stakeholders aware of the criticality of the timelines.
Training success principles and cultural codex
A training was designed for and given to a new operations group, young professionals with a very diverse cultural background, recently hired to start up and run a new production facility. In the dedicated training the following aspects of the freshly introduced cultural codex and success principles were covered: Greeting culture, taking 100% responsibility, managing your response and thoughts, asking for help and perception differences.
Endorsements
Excellent collaborator
‘Karin is an excellent project manager and collaborator with great experience managing complex, multi-disciplinary programs. She is highly organized, professional, strong technically, and able to motivate other team members effectively. She is also a person of high integrity and works diligently to ensure that commitments are kept and timelines met. I have always enjoyed working with Karin and am pleased to be able to provide this recommendation.’
Tom Ransohoff, Managing Director at BDO USA, LLP, Woburn, Massachusetts
Karin combines passion, strategic vision and attention to detail
‘Karin is an excellent project manager who combines passion, strategic vision and attention to detail to successfully deliver complex, demanding projects. Karin is able to call on her significant experience to develop pragmatic approaches to problem solving, and remains focused on the goals and timelines in the face of headwinds and pressures. She is able to motivate, encourage and hold team members to account for milestone delivery and develop strong, enduring relationships with clients and colleagues. Karin is expert in biopharmaceutical development and manufacture, risk management and is a strong communicator. I have no hesitation in recommending Karin as a freelance project management consultant’
Derek Ellison, Associate Vice President CMC Development Operations at Allergan, Liverpool, United Kingdom
Karin creates a safe atmosphere from the beginning
'We asked Karin to design and give a training to our new Operations group, a group of young professionals with a very diverse cultural background, recently hired to start up and run our new production facility. Karin combined aspects of the freshly introduced cultural codex and personal empowerment into the training and managed to create a safe and relaxed atmosphere from the beginning. What I liked most about the training were the moments where we were asked to reflect on job motivation, professional goals and on past year successes. Moreover, Karin came up with a lot of good stories out of her own life and our daily practice, making it easy for us to connect, identify with the learnings and immediately apply them after the training'
Jane Karina Nielsen, Head Manufacturing DD Drug Substance Plant, Lonza, Visp, Switzerland