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• Provide operational strategy, leadership, oversight and troubleshooting |
• Negotiate, contract and manage vendor agreements |
CSO |
Nick Lukacs, PhD is co-founder and Chief Scientific Officer of Opsidio. A recognized immunologist, Nick led the discovery of the unique role SCF248 plays in the cycle of chronic inflammation. It was this discovery that led to the development of Opsidio's anti-SCF248 program. Over the past 25 years Nick has managed a ve... |
Responsibilities: |
• Overall scientific leadership of anti SCF248 program |
• Laboratory component of biomarker development |
• Lab management |
• Characterization of newly-developed antibodies |
Head of CMC |
Patti Seymour, PhD will be the functional Head of CMC for Opsidio. Patti has worked with Opsidio as a consultant for the past two years through BPTG/BDO. She led the RFP process for our CDMO selection and thoroughly understands the program requirements. |
A Managing Director at BPTG/BDO, Patti is an expert in biopharmaceutical supply chain management, CDMO selection, CMC technical and regulatory strategy and program management. Patti has more than 25 years of experience working with companies to advance biologic products by guiding cGMP drug substance and drug product m... |
Responsibilities: |
• Management and oversight of cell line development to be performed by Selexis, S.A. |
• Management and oversight GMP services to be performed by KBI Biopharma and as defined in IDP |
• Fill/Finish vendor selection and management |
• CMC Sub-team lead representative |
• Please see BDO service proposal for detailed activities |
Head of Clinical and Project Management |
Charles Schweizer, PhD is our Head of Clinical and Project Management. This is a highly cross functional role involving deep understanding of clinical operations, quality systems, vendor management and strong project management. |
Dr. Schweizer has over 24 years product development and operations experience across pharmaceutical companies, biotechs, and CROs. Most recently he served as Vice President, Clinical Operations at Galera Therapeutics, a public biotechnology company developing radiotherapeutics, where he provided senior management overs... |
Prior to Morphotek he has held strategic and operational positions at PRA International, Ilex Oncology, and Bristol Myers-Squibb. He has presented and published numerous manuscripts and abstracts across clinical research and product development fields. |
Responsibilities: |
• Establishment and leadership of project management and communication |
• Quality and performance metrics |
• Clinical Operations |
• IND team lead |
Job Descriptions of Anticipated Hires |
Project Manager (PM) |
Description |
Reports to |
Key Responsibilities |
Experience |
Head of Quality Assurance |
Description |
Reports to |
Key Responsibilities |
Experience |
Senior Scientist |
Description |
Reports to |
Key Responsibilities |
Experience |
Project Management Plan |
Opsidio will establish an Integrated Project Management (PM) Plan to ensure alignment with AbbVie and other key stakeholders. The Project Manager will own the Integrated PM Plan. This plan will detail how the program will be executed, monitored, and controlled. One of the key inputs to the Integrated PM Plan is the Pro... |
• Project Scope & Requirements |
• Project Schedule |
• Project Resource Management |
• Communication Management |
• Risk Management |
• Stakeholder Engagement |
Each element included in the plan is an iterative process, meaning it can and most likely will change and be refined over time. This is expected and each major change to the elements of the plan will be captured and versioned as appropriate by the project manager. The communication plan which is discussed in the Commun... |
Project Scope and Requirements Management |
To ensure full alignment between key stakeholders and project team members, a detailed summary of the scope and requirements for the project will be documented. The scope will clarify for stakeholders and project team members what is in and out of scope for the project. This ensures that only the work that is required ... |
Project Schedule Management |
A detailed listing of the project milestones, activities, and deliverables will be created and managed for the life of the project. This will include all the major elements necessary to successfully deliver on the project. The schedule will provide enough detail to allow project team members and stakeholders to maintai... |
Project Resource Management |
The project resource management document will capture details that identify and enable acquisition of individuals with the appropriate skills and talent to execute the project. This plan ensures that the right resources are acquired at the appropriate timeframes to successfully complete the project. This plan will esti... |
Communication Management |
A detailed communications plan will be created which will be aligned with the Definitive Agreement. The communications plan will ensure there is an appropriate mechanism to create, collect, distribute, store, retrieve, manage, and monitor project information. The plan will also identify key stakeholders and stakeholder... |
Risk Management |
A risk register with any perceived or actual risk and gaps will be created to define, monitor, and communicate challenges that may impact the project. The goal is to minimize the probability and/or impact of negative risk to the project. The risk register will capture at minimum a detailed and itemized list of risk wit... |
• Category or risk/gap |
• Risk/gap description |
• Likelihood risk will occur |
• Impact of risk/gap |
• Severity of risk/gap |
• Risk owner |
• Risk mitigation action |
The risk register will be maintained as documented in the communication plan. |
Stakeholder Engagement |
A defined plan for managing people, groups, or organizations that could be impacted or impact the project will be documented. A plan for engaging such stakeholders will be documented and will incorporate any requirements from the Definitive Agreement. |
Note to draft: The full plan is in process. |
Quality Plan |
Opsidio is committed to quality in all parts of operations throughout the company and will apply an overarching quality plan using a Quality Management System (QMS) to assure high standards of quality during all aspects of product development. In order to fulfill this commitment, Opsidio will ensure an operating QMS to... |
The QMS is structured around ISO 9001:2015 principles and fully incorporates the requirements of federal regulations and all applicable GxP guidelines. Opsidio's QMS sets and maintains quality standards and compliance through a framework of standard operating procedures (SOPs), document control, change/ deviation contr... |
Opsidio's QA head (or designee) will systematically identify and label all SOPs tracked via a master SOP list. This master list will indicate the SOP number, date of issuance, and title, and may be used to support audits or inspections. These SOPs will be revised as necessary to reflect continuous process improvement, ... |
Opsidio's QMS includes document control with a description of the document numbering and hierarchy approach, document control practices, document archiving and retention, and general good documentation practices. A change control system facilitates change for continuous improvement, which ensures that the company is co... |
The Quality System is manual. Quality documents will be stored in a logical filing system hosted on Box.com, which is 21 CFR Part 11-compliant. |
Opsidio will utilize an SOP for investigating and controlling quality events (QEs) and associated corrective and preventive actions (CAPA) resulting from these events in compliance with regulatory requirements. This procedure applies to all GxP activities in accordance with relevant regulatory and Opsidio requirements,... |
Opsidio QA will be an independent function from other GxP functions within the company, and will manage a quality management plan that incorporate routine interval auditing, new vendor auditing, and for-cause auditing. Audits may be conducted internally or outsourced to an independent auditor for quality systems, produ... |
Opsidio will be integrating a system for management review of the quality plan and risk management to ensure quality management systems have leadership support consistent with ISO 9001. Regular meetings will be held between the leadership team, quality assurance heads, and process owners to discuss improvements to qual... |
It is the responsibility of the respective Opsidio GxP functional area heads to ensure that all GxP activities follow Opsidio's QMS SOPs and documents, and any outsourced activities will be properly contracted and detail whether the vendor SOPs are applied to the scope of work. The respective department heads are also ... |
A training matrix of required SOPs will be developed for each position. Training records will be maintained in accordance with the SOP. |
SOP List |
As many of the GxP activities in the IDP will be performed by qualified vendors, Opsidio will rely on the established procedures of the vendor. As part of the processes governed by the SOPs "Consultant and Supplier Qualification" and "External GXP Audit", Opsidio will ensure that the vendor has all of the necessary and... |
The development and implementation of SOPs will be staged as the program progresses. The following SOPs are in process and will be finalized by the time of signing of a Definitive Agreement. SOPs for later stage activities will be developed well before the initiation of the activity. |
QM0001 Quality Manual |
QA0001 Responsibilities of Quality Assurance and Management |
QA0002 Control of Quality Systems Documentation |
QA0003 Good Documentation Practices |
QA0004 Selection and Management of GXP Service Providers |
QA0005 External GXP Audit |
QA0006 Approval of Externally Generated Master Batch Records |
QA0007 Batch Record Review |
QA0008 Product Disposition |
QA0009 Format of Standard Operating Procedures |
QA0010 Generation and Format of Product Specifications |
QA0011 Training Program |
QA0012 Change Control |
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