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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

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Associate Director - Stem Cell Project Management Job

Date: Mar 11, 2019

Location: Fremont, CA, US

Company: Novo Nordisk

About the Department

Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s decease and chronical heart failure

The Position

The Associate Director Stem Cell Project Manager will have the overall responsibility for managing collaborations, stem cell projects, and for preparing the site for production of stem cells.


Relationship:

The Associate Director Stem Cell Project Manager will work at the Stem Cell manufacture facility located in Fremont, California and will report to the Head of Stem Cell Manufacturing. Internal stakeholders include employees in Research & Development (R&D) in Novo Nordisk A/S, employees of University of California San Francisco (UCSF), employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality. External stakeholders include consulting firms and employees at Novo Nordisk Engineering.

Essential Functions:

• Manage the development of the derivation methods to ensure they will fulfil Good Tissue Practices (GTP)/Good Manufacturing Practices (GMP) for the derived human Embryonic Stem Cell (hESC) lines. This includes the strategy for the quality of all the raw materials, reagents, buffers and media, that all fulfill the GMP for Advance Therapy Medicinal Product’s (ATMPs) requirements both for the derivation of hESC line and following Master Cell Bank (MCB) and Working Cell Bank (WCB).
• Manage and ensure the right quality of the collection of the embryos from the In Vitro Fertilization (IVF) clinic, as well as release the embryos for further use.
• Manage and ensure that the analysis to be used for in process analysis, release testing of raw materials and release testing of final products.
• Participate in writing to the health authorities (HA) briefing documents and questions, this include the Danish HA as well as Food and Drug Administration (FDA) and European Medicines Agency (EMA). Manage and organize: Steering and project committee meetings (GTP responsible for Novo Nordisk ensuring that all work at the IVF clinic meets GTP requirements according to EMA and FDA: consent forms, testing of the donors, analysis to be carried out at Clinical Laboratory Improvement Amendments (CLIA) certified labs, with FDA recommended tests, evaluation of the data, transfer of the embryos according to GTP/GMP, etc. GTP responsible also includes the responsibility for the interaction between UCSF IVF clinic and UCSF GMP facility lives up to GTP.
• Responsible for evaluating possible existing hESC lines, CMO facilities, GMP facilities according to GTP.
• Actively participate in working groups across SVP area regarding the strategy for the stem cell MCB, and other stem cell projects, including devices, quality, alignment and standardization of the process in connection to the stem cell project(s).
• Actively participate in establishment of strategies for the definition, qualification and development of media, and facilities with respect to GMP process for the derivation of hESC line and following MCB and WCB.
• Actively participating in supplier evaluation in collaboration with strategic sourcing and collaborators.
• Involved in establishment of strategies for existing and new incoming stem cell projects, including stem cell product administration and devices (excipients), etc.
• Responsible for assuring the correct GTP/GMP level of quality for the seed lines and following hESC MCBs/WCBs to be used for regulatory toxicology and FHD.
• Responsible for decisions with regard to equipment in GMP facilities, risk assessment, installation and qualification of equipment Cross functional project management.
• Evaluate GMP facilities to be used as back-up for manufacturing of the MCBs/WCBs as well as for the beta-cell product and Parkinson.
• Stem cell specialist with respect to cleaning evaluation between products manufactured with and without animal derived raw materials.
• Stem cell specialist on in process analysis, manufacturing and quality of the raw materials to be used for regulatory toxicology and pharmacology (FHD), late development and market, in connection to getting Fremont ready for manufacturing.

Communication with stakeholders:
• Responsible for transfer of the GMP derivation method to the GMP facility and to ensure that the facility will be ready for the derivation of GMP hESC lines in Q1 2019, stakeholder management requires two meetings per week and daily follow-up on mail to ensure minor details are solved when they arise. The involved groups are Novo Nordisk hired personnel and Novo Nordisk Employees currently working on the performance qualification (PQ) of the equipment.
• Improve the collaboration and communication between own and other departments
• Facilitate activities in the critical path of project development in any area where her input is relevant (e.g. analytics, regulatory, production, quality assurance).
• Ensure focus on quality in the projects one is involved in, either in a project management or in a scientific role.

Physical Requirements:

Approximately 30% overnight travel.

Qualifications:

• Ph.D. required in the life sciences field required.
• 10+ years’ experience in Drug Development and Project Management required.
• Strong communication, collaboration and coordinating capability, long- term and short-term project management.
• Strong strategic, analytical and problem solving capacity; reframing and change management skills.
• Quick problem-solving capabilities and very good innovative skills combined with a high degree of independence and initiative.
• Ability to organize very complex tasks to be solved between a number of different functional areas and key stakeholders such as UCSF.
• Extended knowledge in analysis, development, validation and transfer of methods.
• Managerial Experience (if applicable).


Requisition ID: 59612BR
State/Provinces: Fremont
Job Category: Research


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

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