NCBiotech
Overview
TITLE:
Director, Product Development
Reports To:
VP, CMC Operations
Location:
Raleigh
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. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.
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. The QbD approach must utilize scientific knowledge and risk management to identify and mitigate potential quality issues early on.
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 including:
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) to verify that manufacturing processes operate within predefined specifications and that material meets all 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 may include manufacturing process, analytical method, stability testing, and formulation changes. Generate supporting CMC information as needed to support the change (e.g., comparability assessment, risk-based approach).
Responsible for the direct technical management of 3rd party CROs and 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.
Work effectively with other personnel 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; 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 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 in managing formulation development, analytical development, process development, and quality control groups. Experience with creating, managing, and reporting various project plans and budgets. Experience with Quality by Design.
Travel:
Domestic and international as needed (approx. 10%)
Competencies/Conduct In addition to the minimum qualifications, the employee will demonstrate:
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 cGMP and cGLP
Proven success at taking products through research and development onto the market
Ability to supervise and direct others 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
Preferred Qualifications Pharmaceutical principles, practices and their application.
Benefits
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 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
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.
Compliance Obligations Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:
Employee Obligations
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Risk IQ: Know what policies apply to your role and function and adhere to them.
Speak Up: If you see something, say something.
Manager Obligations
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
Model and reinforce a Speak Up culture on your team.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
Equal Employment Opportunity EOE/Minorities/Females/Vet/Disabled
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Director, Product Development
Reports To:
VP, CMC Operations
Location:
Raleigh
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. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.
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. The QbD approach must utilize scientific knowledge and risk management to identify and mitigate potential quality issues early on.
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 including:
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) to verify that manufacturing processes operate within predefined specifications and that material meets all 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 may include manufacturing process, analytical method, stability testing, and formulation changes. Generate supporting CMC information as needed to support the change (e.g., comparability assessment, risk-based approach).
Responsible for the direct technical management of 3rd party CROs and 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.
Work effectively with other personnel 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; 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 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 in managing formulation development, analytical development, process development, and quality control groups. Experience with creating, managing, and reporting various project plans and budgets. Experience with Quality by Design.
Travel:
Domestic and international as needed (approx. 10%)
Competencies/Conduct In addition to the minimum qualifications, the employee will demonstrate:
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 cGMP and cGLP
Proven success at taking products through research and development onto the market
Ability to supervise and direct others 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
Preferred Qualifications Pharmaceutical principles, practices and their application.
Benefits
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 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
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.
Compliance Obligations Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:
Employee Obligations
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Risk IQ: Know what policies apply to your role and function and adhere to them.
Speak Up: If you see something, say something.
Manager Obligations
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
Model and reinforce a Speak Up culture on your team.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
Equal Employment Opportunity EOE/Minorities/Females/Vet/Disabled
#J-18808-Ljbffr