Publicerad: 11 januari
Sista ansökan: 29 juni
Arbetsbeskrivning
At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have a globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.
We are now seeking a Head of Analytical Development to our Analytical Development team.
As Head of Analytical Development you will be responsible for providing
leadership of the activities related to the analysis,
method development, stability and testing of drug substance
DS) and drug products (DP)
for cell therapy projects. You will provide scientific guidance and technical support and be responsible for building and growing an analytical development group, as well as managing a team of capable analysts. You will be required to work in a leadership capacity, liaising with various other managers from Quality Control (QC), Process Development (PD), Supply Chain (SC), and the MSATs groups.
The successful candidate is expected to be an analytical expert with a thorough understanding of cell therapy products and their quality attributes. The incumbent will be empowered to lead the creation and delivery of the analytical strategy to support the development of an analytical platform for cell therapy clinical output.
Responsibilities
- Support, manage, and tutor a team of analytical scientists in cell therapy analytical technologies, including but not limited to Flow Cytometry, NucleoCounter, ddPCR/PCR, ELISA.
- Analytical leader and expert to facilitate the generation of analytical reports required for regulatory submissions and interactions.
- Provide strategic insight and leadership required for cell therapy analytical development work in line with the principles of QbD (quality by design).
- Responsible for development, qualification and establishment of analytical testing methodologies to control raw materials, intermediates, IPC and final product in compliance with the regulatory guidelines.
- The analytical development manager will be required to draft SOPs in line with cGxP for analytical oversight of process development / scale-up and MSATs.
- The role will also require limited project management (PM) responsibilities in relation to the analytical development group.
- Responsible for coaching, supervising, mentorship, development, support and line leadership of the analytical development group.
- Ensure a learning environment and foster a culture of scientific excellence through training, influencing, and leading by example in a fast-paced cell therapy biotech company.
- Support the implementation of stability strategies, sampling plans, and work instructions.
- Comply with company policies, risk assessments, instructions, and protocols.
- Prepare, review, and revise GMP critical documentation; CMC sections related to analytical methods, method validation, specifications, and stability protocols for regulatory submissions.
- Provide scientific guidance on investigations related to analytics at Procella, including resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results, change control (CC), and CAPAs.
- Participate in and/or lead projects internal and external method transfers.
- Ensure team maintenance of good analytical data, laboratory notebooks and results, to ensure data integrity.
Required Qualifications & Experience
- A minimum of 3 years of experience in leadership in a similar role with proven leadership skills and strategic problem-solving ability.
- Cell therapy method expertise, development, qualification, and tech transfer.
- A minimum of 5 years of industry experience in analytical development.
- Working knowledge of MS Excel, Word, and PowerPoint.
- BSc or above in life science or equivalent, a PhD would be preferred.
- Experience in cell therapy is desired.
- Project Management experience is an asset.
- Fluency in English is required.
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 65 employees from more than 20 nationalities.
We are now seeking a Head of Analytical Development to our Analytical Development team.
As Head of Analytical Development you will be responsible for providing
leadership of the activities related to the analysis,
method development, stability and testing of drug substance
DS) and drug products (DP)
for cell therapy projects. You will provide scientific guidance and technical support and be responsible for building and growing an analytical development group, as well as managing a team of capable analysts. You will be required to work in a leadership capacity, liaising with various other managers from Quality Control (QC), Process Development (PD), Supply Chain (SC), and the MSATs groups.
The successful candidate is expected to be an analytical expert with a thorough understanding of cell therapy products and their quality attributes. The incumbent will be empowered to lead the creation and delivery of the analytical strategy to support the development of an analytical platform for cell therapy clinical output.
Responsibilities
- Support, manage, and tutor a team of analytical scientists in cell therapy analytical technologies, including but not limited to Flow Cytometry, NucleoCounter, ddPCR/PCR, ELISA.
- Analytical leader and expert to facilitate the generation of analytical reports required for regulatory submissions and interactions.
- Provide strategic insight and leadership required for cell therapy analytical development work in line with the principles of QbD (quality by design).
- Responsible for development, qualification and establishment of analytical testing methodologies to control raw materials, intermediates, IPC and final product in compliance with the regulatory guidelines.
- The analytical development manager will be required to draft SOPs in line with cGxP for analytical oversight of process development / scale-up and MSATs.
- The role will also require limited project management (PM) responsibilities in relation to the analytical development group.
- Responsible for coaching, supervising, mentorship, development, support and line leadership of the analytical development group.
- Ensure a learning environment and foster a culture of scientific excellence through training, influencing, and leading by example in a fast-paced cell therapy biotech company.
- Support the implementation of stability strategies, sampling plans, and work instructions.
- Comply with company policies, risk assessments, instructions, and protocols.
- Prepare, review, and revise GMP critical documentation; CMC sections related to analytical methods, method validation, specifications, and stability protocols for regulatory submissions.
- Provide scientific guidance on investigations related to analytics at Procella, including resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results, change control (CC), and CAPAs.
- Participate in and/or lead projects internal and external method transfers.
- Ensure team maintenance of good analytical data, laboratory notebooks and results, to ensure data integrity.
Required Qualifications & Experience
- A minimum of 3 years of experience in leadership in a similar role with proven leadership skills and strategic problem-solving ability.
- Cell therapy method expertise, development, qualification, and tech transfer.
- A minimum of 5 years of industry experience in analytical development.
- Working knowledge of MS Excel, Word, and PowerPoint.
- BSc or above in life science or equivalent, a PhD would be preferred.
- Experience in cell therapy is desired.
- Project Management experience is an asset.
- Fluency in English is required.
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 65 employees from more than 20 nationalities.
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