Indivior
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Director, Product Development
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Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Position Summary Responsible for all aspects of the Chemistry, Manufacturing, and Controls (CMC) Drug Product Development including: New drug product development projects – Analytical, formulation, packaging, and process development applying a systematic, proactive Quality By Design (QbD) approach and using an outsourced development model. New drug product development projects – The manufacture and supply of clinical supplies. Post-Approval Drug Product Support – Apply prior knowledge and Subject Matter Expertise in partnership with Supply and Quality Assurance to support Indivior’s existing commercial drug products to include: Support timely and effective investigation and closure of deviations and out of specifications, Review the emerging ongoing stability data review for compliance with registered specifications Set up and undertake Continuous Process Verification (CPV) which is the science and risk-based real-time approach to verify and demonstrate that Indivior’s manufacturing processes operate within the predefined specified parameters consistently produces material which meets all its critical quality attributes (CQAs) and control strategy requirements. Ensure from a CMC perspective the consistent quality, safety, and efficacy of the drug product during Post-Approval Changes (PACs) that include modifications to the manufacturing processes, analytical methods, stability testing, and formulation. Responsible for the direct technical management of the 3rd party contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) as part of the outsourced CMC development model. Responsible for the direct supervision and development of other team members, including training, guidance, and mentoring on a formal and informal basis. Work effectively with other personnel throughout the company to meet timelines and milestones. Essential Functions The responsibilities of this job include, but are not limited to, the following: attend regularly scheduled CMC, CMO, CRO, and core project team meetings, as well as Global R&D Leadership team meetings; support Project Managers and CMC project budgets; coordinate project workshops as needed to focus on key project activities; review and provide input and direction on scientific and other regulatory documents, including meeting packages, INDs, NDAs, EMAs, clinical study protocols, etc. Minimum Qualifications Education: Bachelor’s degree, advanced degree a plus Field of Study: preferably in health sciences Experience: 20 years of experience in pharmaceutical development with emphasis in analytical, formulation, or process development. Experience with Quality by Design. Travel: Domestic and international as needed (approx. 10%) Competencies/Conduct Excellent organization, time management, and analytical skills applicable to various aspects of the pharmaceutical industry High energy, self-motivated with experience in research, development, and post- marketing of products regulated worldwide Specific expertise in Analytical, Formulation, or Process Development that includes Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP) Proven success at taking products through research and development onto the market Ability to supervise and direct others in order to accomplish project milestones and meet timelines Experience with specialized analytical and manufacturing equipment Experience with managing CROs and CDMOs Attention to detail Excellent written and verbal communication skills Proficient in Microsoft Office Word/Excel/PowerPoint Benefits Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. 3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts EOE/Minorities/Females/Vet/Disabled
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Director, Product Development
role at
Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Position Summary Responsible for all aspects of the Chemistry, Manufacturing, and Controls (CMC) Drug Product Development including: New drug product development projects – Analytical, formulation, packaging, and process development applying a systematic, proactive Quality By Design (QbD) approach and using an outsourced development model. New drug product development projects – The manufacture and supply of clinical supplies. Post-Approval Drug Product Support – Apply prior knowledge and Subject Matter Expertise in partnership with Supply and Quality Assurance to support Indivior’s existing commercial drug products to include: Support timely and effective investigation and closure of deviations and out of specifications, Review the emerging ongoing stability data review for compliance with registered specifications Set up and undertake Continuous Process Verification (CPV) which is the science and risk-based real-time approach to verify and demonstrate that Indivior’s manufacturing processes operate within the predefined specified parameters consistently produces material which meets all its critical quality attributes (CQAs) and control strategy requirements. Ensure from a CMC perspective the consistent quality, safety, and efficacy of the drug product during Post-Approval Changes (PACs) that include modifications to the manufacturing processes, analytical methods, stability testing, and formulation. Responsible for the direct technical management of the 3rd party contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) as part of the outsourced CMC development model. Responsible for the direct supervision and development of other team members, including training, guidance, and mentoring on a formal and informal basis. Work effectively with other personnel throughout the company to meet timelines and milestones. Essential Functions The responsibilities of this job include, but are not limited to, the following: attend regularly scheduled CMC, CMO, CRO, and core project team meetings, as well as Global R&D Leadership team meetings; support Project Managers and CMC project budgets; coordinate project workshops as needed to focus on key project activities; review and provide input and direction on scientific and other regulatory documents, including meeting packages, INDs, NDAs, EMAs, clinical study protocols, etc. Minimum Qualifications Education: Bachelor’s degree, advanced degree a plus Field of Study: preferably in health sciences Experience: 20 years of experience in pharmaceutical development with emphasis in analytical, formulation, or process development. Experience with Quality by Design. Travel: Domestic and international as needed (approx. 10%) Competencies/Conduct Excellent organization, time management, and analytical skills applicable to various aspects of the pharmaceutical industry High energy, self-motivated with experience in research, development, and post- marketing of products regulated worldwide Specific expertise in Analytical, Formulation, or Process Development that includes Good Manufacturing Practice (cGMP) and Good Laboratory Practice (cGLP) Proven success at taking products through research and development onto the market Ability to supervise and direct others in order to accomplish project milestones and meet timelines Experience with specialized analytical and manufacturing equipment Experience with managing CROs and CDMOs Attention to detail Excellent written and verbal communication skills Proficient in Microsoft Office Word/Excel/PowerPoint Benefits Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. 3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts EOE/Minorities/Females/Vet/Disabled
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