Job description

Responsibilities:

• Excellent employment opportunity for a Drug Substance CMO Supply Manager in the Gaithersburg, MD area.
• Oversee and help drive the end-to-end production/manufacture, supply, and distribution of DS (including raw materials and precursors) from Company’s external contract manufacturing partners.
• Support the progression of pipeline assets through the various stages of development, the DS CMO Supply Manager will collaborate with and act as a liaison between various internal and external stakeholders to inform work responsibilities.
• Ultimately, will be accountable for proactively planning and ensuring the timely execution of agreed-upon [activities for] biologics for ongoing and upcoming clinical campaigns as well as development requirements.
• This role may contain varying levels of complexity and the successful candidate must have a high level of independence to meet requirements outlined below with minimal supervision.
• Works collaboratively cross-functional teams (internally and externally as required), to manage and oversee outsourced DS manufacturing operations for assigned projects.
• Independently plan and manage aspects of tech transfer for production of clinical and non-clinical DS at manufacturing vendors.
• Manages DS supplier setup in Company systems.
• Supports Strategic Sourcing function in contract initiation and statements of work (SOW) with DS vendors.
• Manages purchase orders, invoices, scope changes, and communication and forecasting of DS financials to CMC Project Manager.
• Acts as primary point of contact and provides DS CMO oversight and coordination from manufacture to DS bulk fill, storage, and coordination of distribution for 3 to 6 specified Development Projects at all development stages
• Supports the CMC team as point of contact for DS CMO tech transfers
• Evaluate DS vendor performance and partner relationship
• Leads the coordination of gathering required DS or DS pre-cursor licenses
• Responsible for ensuring the correct tax management of clinical and development DS logistics
• Ensure compliance requirements and related elements of documentation, reports and records
• Liaise with External Quality (EQ) and Product Quality Lead (PQL) for DS CMO release.
• Partner with stakeholder departments to identify critical challenges and risks associated with DS CMO activities
• Attend and actively participate in departmental meetings providing relevant project updates when necessary

Experience:

• Requires a Bachelor’s Degree in basic / applied Science or Engineering.
• Equivalent level of training in service may also be considered.
• Direct experience in a development or technical operations environment in the Pharmaceutical, Scientific or Health Care product industry.
• Specific experience in the management, development or preparation of aseptically produced products is desirable.
• Demonstrated proficiency in managing the logistics of the manufacture, supply, and distribution of clinical and non-clinical material
• Experience with biologics manufacturing operations and drug development process is strongly preferred
• Experience or good working understanding of cGMP environment and guidelines and Code of Federal Regulations and FDA Guidance for Industry
• Ability to work in a dynamic environment and collaborate effectively within cross functional teams
• Relevant training or experience in logistics, outsourcing, procurement, and vendor management required.
• Excellent organization skills, strong attention to detail, and a skillset oriented to planning, coordination, teamwork, and clear communication
• Proficiency in Microsoft Outlook, Teams, Word, Excel, SharePoint, Power Point, and use of repositories (like Box) is expected
• Comfortable with ambiguity
• Desired Skills:4+ years industry experience

Familiarity with Coupa or other procurement and logistics management system

Job Type: Contract

Salary: $46.00 - $61.00 per hour

Schedule:

• 8 hour shift

Work Location: Remote

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