Logistics and Supply Manager

**Title**: Logistics and Supply Manager

**Location**: Cambridge

**Remote/Onsite Requirement**: 2-3 days a week onsite (flexible)

**Duration of Contract**: 6 months (good chance of extension to 12 months but not guaranteed)

**QDOS Determination**: Outside of IR35

**Pay Rate**: Ltd/Umb - 425

PAYE - 335

**Main Duties & Responsibilities**:

- 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 outsourceddrug 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 our 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 movementof 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 allother activities related to cGMP, GCP 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 recommendationfor risk mitigation.Overall, ensure smooth and on-time delivery of supply for clinical DP manufacture and clinical studies.
- 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.

**Education & Experience Requirements**:

- 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 preparationof aseptically produced products is desirable.
- Demonstrated proficiency in managing the logistics of the manufacture, supply, and distribution of clinical material
- Experience with GMP biologics manufacturing operations and sound understanding of the drug development process is strongly preferred
- Experience or good working understandingof 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.