Manager Supply Chain
Posted on :
19-03-2024
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
19-03-2024
Job Description
Req ID : 2643533
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
Position: Manager Supply Chain
Location: Santa Monica CA 94404
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Description:
- Manager Supply Chain is an enthusiastic team player who will provide expertise in a fastpaced pharmaceutical clinical supplies environment for Clients global clinical trials.
- The Manager works collaboratively with other members of GCSC PDM and DevOps staff to meet project deliverables solve business problems and create competitive advantage.
- This role has great exposure to all elements of the clinical supply chain from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at the clinical sites worldwide.
Specific Job Requirements:
- Responsible for managing supplies for dynamic clinical studies associated with multiple clinical development programs across the lifecycle of the programs (Phase 1 2 3 Managed Access).
- Leads end toend clinical supply responsibilities including but not limited to protocol interpretation demand planning supply planning distribution inventory management label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs).
- Works collaboratively with Clinical Operations Formulation Process Development Device Development and Clinical Package Engineering Quality Assurance Regulatory Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP).
- Partners with Quality Assurance to resolve qualityrelated issues with labels/labeling/distribution vendors in a timely manner and develops holistic corrective actions to prevent recurrence.
- Partner with Regulatory to ensure labels meet global regulatory requirements and filings accurately reflect the global supply chains.
- Oversees labeling/distribution contractor activities and relationships and participates in vendor selection onboarding management issue resolution and continuous improvement.
- Actively participates in and supports continuous improvements programs processes and systems.
- Stays current with industry trends and best practices with respect to clinical supply management as well as changes in the regulatory landscape that would impact clinical supply chain.
- Authors and reviews SOPs and labeling batch records required for distribution and clinical labeling activities to ensure GMP compliance.
- Prepares and/or approves purchase orders and supports the budgeting process.
- Examines functional issues from a broader organization perspective and supports day to day operation activities as needed.
Knowledge:
- Excellent verbal written and interpersonal communication skills.
- Strong computer and organizational skills. Project management experience.
- Able to anticipate client obstacles and difficulties and act upon this to meet goals.
- Ability to write clear concise and errorfree documents.
- Ability to exercise judgment within defined procedures and policies to determine and take appropriate action.
- Possess a strong knowledge of the FDA cGMP and GCP standards as well as regulatory guidance documents such as Annex 13.
- Possess clinical supplies experience/knowledge in forecasting demand / supply planning IRT systems inventory management clinical labeling and distribution including cold chain import/export and reverse logistics.
- Possess strong collaboration influencing and negotiation skills to work effectively with internal crossfunctional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
- Works well with ambiguity can assess options quickly and efficiently and implement best option in alignment with Clients culture and expectations for clinical timelines.
Education and Experience:
- Requires a Bachelors degree preferably in a sciencerelated field
- 8 years of relevant industry experience (preferably in endtoend clinical supply management including clinical labeling)
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Employment Type
Full Time
Key Skills
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