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Associate Clinical Supplies Manager

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This is a full-time salaried position.

The **Associate Clinical Supplies Manager** under the guidance of the Clinical Supply Managers/Senior Clinical Supply Managers/Regional Manager CSM (CSM/S-CSM/RM-CSM) undertakes the activities required to lead 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 **Associate Clinical Supplies Manager** is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials for delegated tasks. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise.

The **Associate Clinical Supplies Manager** will have direct interaction with a client, sponsor or clinical vendors and may be responsible upon request to participate in clinical supply calls where tracking of key actions and minute/note taking will be required.

May have responsibilities for supporting the training and mentoring of other **Associate Clinical Supplies Manager’s** within the team. To promote continuous improvement in all aspects of the job: Coordination with PM, external vendors and client to ensure the highest level of client service.

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.

The Role:

+ Understand and translate clinical study protocol requirements into demand for drug product within a clinical study, with support of the Clinical SupplyManagers/Senior Clinical Supply Managers/Regional Manager Clinical Supply Manager (CSM/S-CSM/RM-CSM)

+ Creation of initial study drug projections and supply plan for clinical supply needsthroughout life of study including multiple drug campaigns and appropriate drug strategies, with support of the CSM/S-CSM/RM-CSM

+ 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, with support of the CSM/S-CSM/RM-CSM

+ Create a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug, with support of the CSM/S-CSM/RM-CSM

+ 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, with support of the CSM/S-CSM/RM-CSM

+ Manage drug supply quantities for distribution to designated Warehouses and Depots throughout study, with support of the CSM/S-CSM/RM-CSM

+ Provision of budget estimates in support of quotations for clients, with support of the CSM/S-CSM/RM-CSM

+ Other duties as assigned

The Candidate:

+ Bachelor's degree in a science, supply chain or related discipline, required

+ Minimum one year relevant industry experience, required

+ Understanding 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), required

+ Experience of using MS Office programs, with a particular aptitude for MS project and Excel, required

+ Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management, required

+ 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

+ Community engagement and green initiatives

+ Generous 401K match

+ Medical, dental and vision benefits effective day one of employment

+ Tuition Reimbursement

+ WellHub - 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 (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .