Working with CCXI Senior Management, Contract Development Organizations and selected Consultants, this individual is responsible for the development and overseeing the execution of all the technical activities associated with product development in support of Clinical Development and Commercialization. In particular those activities associated with analytical methods development in support of active pharmaceutical ingredient and drug product development. The individual should be knowledgeable in drug product manufacturing process for oral solid dosage forms. In addition, this individual will be responsible for overseeing all the CMC activities supporting CCXI programs including the development timelines and deliverables according the Department goals.
- The Pharmaceutical Development Senior Manager/Associate Director is responsible for providing project management and technical expertise to the CMC activities for ChemoCentryx programs.
- Responsible for providing technical expertise to all the activities associated with the formulation and process development
- Responsible for providing technical expertise with all the analytical development activities in support of API and DP development
- Responsible for overseeing the manufacture of clinical trial materials at the selected CMO
- Working closely with the QA organizations provide solid input in the resolution of issues associated with the manufacture and release fo CTM
- Working closely with QA responsible for the development and maintenance of an accurate inventory of the Clinical Supplies
- The scope of the responsibility is from IND, Phase 1, 2, 3 to Commercialization and post approval life cycle management.
- The Senior Manager/Associate Director participates in all projects and will manage multiple program collaborating with the CCXI following groups: Process Chemistry, Biology, DMPK, Pre-
- Clinical, Outsourcing, Clinical Operations, Quality, Finance and Regulatory Affairs.
- The Senior Manager/Associate Director will have support project management to the Outsourced Key Accounts Teams.
- Facilitates the design and implementation of initiatives with the CMO’s that improves business performance
- Able to develop a strong background in performance metrics and reporting for business review meetings with the CMO’s
- Follows up and drives the closure of action items from the team meetings and business review meetings
- The Senior Manager/Associate Director should have significant knowledge, experience and skills with compliant Quality Management Systems in support of Product Development and overall CCXI business
- Collaborating with CCXI Quality Organization, establishes, oversees, expands and maintains a SOP’s related to Pharmaceutical Development.
- Leads continuous improvement efforts in quality systems and department infrastructure (including documentation) through the evaluation of current organizational process, audit feedback, and previous experience
- Develops plans and implements actions to ensure readiness for regulatory and audit inspections.
- Works closely with QA to support the review and approval of batch record, validation, specification and change control documentation produced by CMOs and CROs.
- Working closely with PD management and QA oversees the CMOs and CROs performance associated with the investigations and effective closing of all deviations and ensures that robust corrective actions are identified and quickly implemented.
- Establishes and maintains documentations specific for each CMO and each product related to outsourced operations (e.g. contractor manuals)
- Performs CMC technical audits potential CMO’s to ensure technical capabilities, compliance to relevant regulations
- Provides support for the oversight of site technical validation activities (analytical and drug product manufacturing).
- Assists in the preparation and review of regulatory submissions for USA and worldwide heath agencies.
- BS, MS or PhD of a scientific degree with 5 to 15 years of technical and direct product development experience in the areas of Drug Product Formulation/Manufacturing Process/Analytical Development
- Proven experience in the development of analytical methods and their qualification/validation in support to API and products in the late phases of development.
- Deep knowledge of the GMP regulations requirements in product development manufacturing and release of clinical and commercial products
- Knowledge of pharmaceutical packaging and labeling and current or impending regulations is desired but not essential
- Proven track record in strategic planning for late stage development programs. Commercial experience desired.
- Must have strong regulatory compliance knowledge including FDA, cGXP, etc.
- Provide technical support during external audits of vendors and subcontractors
- Must be detail oriented with excellent prioritization, organizational and project management skills.
- Superior analytical and problem solving skills.
- Effective communication (written and verbal) skills.
- Ability to travel up to 30%
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