Catalent
Senior Clinical Supplies Manager
Catalent, Trenton, New Jersey, United States,
Senior Clinical Supplies Manager
Position Summary:
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
This is a full-time salaried position: Monday – Friday, 1st shift.
Our Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to being the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients.
The
Senior Clinical Supplies Manager
has demonstrated expertise in performing the activities required to provide leadership and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics). The
Senior Clinical Supplies Manager
is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise.
The Role:
Understand and translate clinical study protocol requirements into demand for drug product within a clinical study.
Use simulation tools and supply chain expertise to provide decision in support of the design of optimized, lean supply chains for individual studies or programs.
Create initial study drug projections and supply plan for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies.
Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans.
Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug.
Provide input to IRT specification design. Recommend IRT threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites.
Works with IRT in creation of system specifications (URS) associated with supply algorithms.
Act as Unblinded Study Drug Manager in testing of IRT system (UAT) and throughout life of the study.
Other duties as assigned.
The Candidate:
Bachelor's degree in a science, supply chain or related discipline, required.
Six+ years of relevant industry experience with at least four years in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle.
Expertise with supply tracking requirements and systems; expert user of forecasting tools.
Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management.
Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR).
Working knowledge of global supply labeling requirements.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
Why You Should Join Catalent:
Defined career path and annual performance review and feedback process.
Diverse, inclusive culture.
152 hours of PTO + 8 paid holidays.
Several Employee Resource Groups focusing on D&I.
Dynamic, fast-paced work environment.
Positive working environment focusing on continually improving processes to remain innovative.
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Competitive salary with possible bonus potential.
Community engagement and green initiatives.
Generous 401K match and Paid Time Off accrual.
Medical, dental and vision benefits effective day one of employment.
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
GymPass program to promote overall physical wellness.
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
#J-18808-Ljbffr
Position Summary:
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
This is a full-time salaried position: Monday – Friday, 1st shift.
Our Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to being the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients.
The
Senior Clinical Supplies Manager
has demonstrated expertise in performing the activities required to provide leadership and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics). The
Senior Clinical Supplies Manager
is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise.
The Role:
Understand and translate clinical study protocol requirements into demand for drug product within a clinical study.
Use simulation tools and supply chain expertise to provide decision in support of the design of optimized, lean supply chains for individual studies or programs.
Create initial study drug projections and supply plan for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies.
Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans.
Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug.
Provide input to IRT specification design. Recommend IRT threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites.
Works with IRT in creation of system specifications (URS) associated with supply algorithms.
Act as Unblinded Study Drug Manager in testing of IRT system (UAT) and throughout life of the study.
Other duties as assigned.
The Candidate:
Bachelor's degree in a science, supply chain or related discipline, required.
Six+ years of relevant industry experience with at least four years in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle.
Expertise with supply tracking requirements and systems; expert user of forecasting tools.
Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management.
Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR).
Working knowledge of global supply labeling requirements.
Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds.
Why You Should Join Catalent:
Defined career path and annual performance review and feedback process.
Diverse, inclusive culture.
152 hours of PTO + 8 paid holidays.
Several Employee Resource Groups focusing on D&I.
Dynamic, fast-paced work environment.
Positive working environment focusing on continually improving processes to remain innovative.
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Competitive salary with possible bonus potential.
Community engagement and green initiatives.
Generous 401K match and Paid Time Off accrual.
Medical, dental and vision benefits effective day one of employment.
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
GymPass program to promote overall physical wellness.
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
#J-18808-Ljbffr