Indivior PLC
Indivior is seeking a Director, Product Development to lead all aspects of Chemistry, Manufacturing, and Controls (CMC) Drug Product Development.
Key Responsibilities:
New drug product development projects, including analytical, formulation, packaging, and process development using a Quality By Design (QbD) approach. Manufacture and supply of clinical supplies. Post-Approval Drug Product Support, including investigation and closure of deviations, review of stability data, and Continuous Process Verification (CPV). Technical management of 3rd party contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). Supervision and development of team members. Essential Functions:
Attend regularly scheduled CMC, CMO, CRO, and core project team meetings. Support Project Managers and CMC project budgets. Coordinate project workshops as needed. Review and provide input on scientific and regulatory documents. Minimum Qualifications:
Bachelor’s degree in a health science field. 20 years of experience in pharmaceutical development, with emphasis on analytical, formulation, or process development. Experience with Quality by Design and managing formulation development, analytical development, process development, and quality control groups. Competencies/Conduct:
Excellent organization, time management, and analytical skills. High energy, self-motivated with experience in research, development, and post-marketing of products regulated worldwide. Specific expertise in Analytical, Formulation, or Process Development, including Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP). Preferred Qualifications:
Pharmaceutical principles, practices, and their application. Benefits:
3 weeks’ vacation plus floating holidays and sick leave. 401(k) and Profit Sharing Plan. Comprehensive Medical, Dental, Vision, Life, and Disability coverage. Health, Dependent Care, and Limited Purpose Flex Spending and HSA options. Guiding Principles:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. EEO Statement:
Indivior is an equal employment opportunity employer and welcomes applications from diverse candidates.
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New drug product development projects, including analytical, formulation, packaging, and process development using a Quality By Design (QbD) approach. Manufacture and supply of clinical supplies. Post-Approval Drug Product Support, including investigation and closure of deviations, review of stability data, and Continuous Process Verification (CPV). Technical management of 3rd party contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). Supervision and development of team members. Essential Functions:
Attend regularly scheduled CMC, CMO, CRO, and core project team meetings. Support Project Managers and CMC project budgets. Coordinate project workshops as needed. Review and provide input on scientific and regulatory documents. Minimum Qualifications:
Bachelor’s degree in a health science field. 20 years of experience in pharmaceutical development, with emphasis on analytical, formulation, or process development. Experience with Quality by Design and managing formulation development, analytical development, process development, and quality control groups. Competencies/Conduct:
Excellent organization, time management, and analytical skills. High energy, self-motivated with experience in research, development, and post-marketing of products regulated worldwide. Specific expertise in Analytical, Formulation, or Process Development, including Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP). Preferred Qualifications:
Pharmaceutical principles, practices, and their application. Benefits:
3 weeks’ vacation plus floating holidays and sick leave. 401(k) and Profit Sharing Plan. Comprehensive Medical, Dental, Vision, Life, and Disability coverage. Health, Dependent Care, and Limited Purpose Flex Spending and HSA options. Guiding Principles:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. EEO Statement:
Indivior is an equal employment opportunity employer and welcomes applications from diverse candidates.
#J-18808-Ljbffr