Clinical/Drug Supply and Logistics Manager

CLINICAL/DRUG SUPPLY AND LOGISTICS MANAGER GAITHERSBURG, MD Hybrid 50% Remote Project Description:

• Works collaboratively within Logistics and Clinical Supply (LCS), CMC Project Management, Biopharmaceutical Development (BPD), Supply Continuity Team, and other interfaces and stakeholders (internally and externally as required), to manage and oversee outsourced drug substance manufacturing operations for assigned projects ensuring that Biopharmaceutical Development (BPD) project goals and milestones are seamlessly achieved.
• Independently plan and manage aspects of tech transfer for production of clinical Drug substance at manufacturing vendors.
• Manages DS supplier setup in client systems.
• Supports strategic sourcing function in contract initiation and statements of work (SOW) with drug substance vendors.
• Manages purchase orders, invoices, scope changes, and communication and forecasting of DS financials to CMC Project Manager.
• Performs as primary point of contact and provides DS CMO oversight and coordination from manufacture to DS fill, storage, and distribution logistics (including movement to storage sites, samples to external and internal testing labs, as well as movement of final bulk drug substance to drug product manufacturing sites) for 3 to 6 specified Development Projects at all development stages (FTIH to Phase 3 supply).
• Coordinates with other LCS functions (vendor management, distribution, program, and study management) and CMC Team functions on drug substance supply strategy and forecasting for clinical and development supply.
• Supports the CMC team as point of contact for DS CMO tech transfers.
• Represents DS CMO activities at cross-functional meetings.
• Tracks DS vendor performance and partner relationship.
• Manages DS supply to ensure plans are optimal and meet overall strategic goals aligned with CMC and clinical development plans.
• Leads the management and coordination of require drug substance or drug substance pre-cursor licenses.
• Responsible for ensuring the correct tax management of clinical and development drug substance logistics.
• Ensure compliance requirements and related elements of documentation, reports, and records.
• Liaise closely with External Quality (EQ) and Product Quality Lead (PQL) activities with respect to CMO Drug Substance manufacture, release, inventory management and distribution, and as pertains to vendor selection, qualification and monitoring and all other activities related to cGMP, Google Cloud Platform and ICH guidelines.
• Partner with stakeholder departments to identify critical challenges and risks associated with DS CMO activities and around ensuring accuracy of demand/supply analysis.
• Communicate and provide input into risk management plans including options and recommendation for risk mitigation.
• Overall, ensure smooth and on-time delivery of supply for clinical DP manufacture and clinical studies.
• Apply skills and knowledge to enable the preparation of new clinical projects, and delivery of novel Drug Substance modalities in accordance with agreed goals.
• Attend and actively participate in departmental meetings providing relevant project updates when necessary.
• Liaise with parties as required to ensure alignment of Drug Substance clinical production scheduling (including appropriate number and timing of manufacturing runs).
• Coordinate with LCS Program Manager as needed to maintain updated total project demand, and liaising with Technical Manager to ensure best practice in project demand/supply analysis.
• When / Where required help establish and provide input for protocols, department SOPs, documentation, contracts etc. to ensure project supply activities are accurately represented and to support continuous improvement for CMO outsourcing.

• Requires a bachelor's degree in basic / applied science or engineering, 4+ years of related experience. Equivalent level of training in service may also be considered.
• The DS Logistics and Supply Manager will have appropriate 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 material.
• 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 to track and deliver on complex projects.
• Relevant training or experience in logistics, outsourcing, procurement, and vendor management required.
• This position requires a high level of commitment, flexibility, and independence with strong skills for planning, coordination, teamwork, communication, and interpersonal relations.
• Excellent organization skills, strong attention to detail, and a skillset oriented to planning, coordination, teamwork, and clear communication.
• Proficiency in Microsoft Outlook, Word, Excel, and Power Point is expected.
• Comfortable with ambiguity.
• Experience in planning coordinating and managing external partners.
• Excellent oral and written communication, interpersonal, analytical, and computer skills.
• Ability to work independently on multiple projects, think strategically, and exercise sound judgement to make decisions in a fast-paced environment.

• Prior Supply chain Planning experience in pharma industry.
• 4+ years industry experience.
• Familiarity with Coupa or other procurement and logistics management system.
• Ability to deliver technical solutions to a wide range of difficult problems requiring ingenuity and creativity.
• Able to effect results through both formal and informal networks and who can effectively multi-task across activities of varying priority.
• Ability to recognize activities or events that may critically affect the availability of drug products and act on or relay that information to appropriate party.
• Experience with GMP biologics manufacturing operations and sound understanding of the drug development process is strongly preferred.