The Senior Manager/Associate Director of Clinical Supply will be responsible for managing the investigational clinical drug supplies in support of AnaptysBio clinical studies. The role is primarily responsible for supporting Clinical Operations, CMC, Quality and program teams by translating clinical study designs into clinical packaging and labeling designs and actionable study supply plans, managing work streams with key service providers and working with internal cross-functional departments and vendors for on-time deliveries of clinical supplies.
- Develops and recommends clinical study supply plans and maintains inventory tracking for both active and placebo drug products as well as bulk biologic substances and intermediates in compliance with company’s internal procedures, GxP requirements and global regulatory requirements.
- Translates clinical enrollment forecasts into clinical trial material forecasts at the study level and tracks material inventory, updates use and expiry dating to ensure uninterrupted clinical supplies. Proactively escalates to management when action is necessary, including shelf life extensions, delays, manufacture of additional supply or submissions to health authorities.
- Actively participates on project teams and provides clinical supply updates and summaries to program teams and management.
- Oversee and execute global clinical drug supply activities associated with project team’s trials (secondary packaging vendor selection, technical batch record review, QP release coordination, clinical label design, packaging and labeling, IRT design and testing).
- Collaborate with team members to identify deviations from plans, risks and issues and prepare contingency plans
- Vendor Management – coordinates and oversees labelling and packaging activities at CROs/CMOs, may serve as Person in Plant (PIP) when packaging operations for clinical trial material are in-process.
- Assists in procurement of comparator drug products and placebos, as required.
- Develops and recommends secondary packaging design based on protocol and manages all packaging activities including work order creation, review and approval of contractor packaging records and monitoring work at contractors. Collaborates with CMC on primary packaging designs.
- Coordinates CTM shipping and logistics activities including management of shipments of CTM from storage/distribution sites to clinical trial sites.
- Coordinates courier deliveries and shipments and manages the courier relationship. Oversees packaging of materials according to current regulations. Oversees special projects, including international shipments requiring US Government certificate / license for worldwide shipment of investigational clinical trial material, drug substance, and drug product.
- Reviews temperature logs for CTM distribution and storage. Investigates temperature deviations according to SOP.
- Actively communicates supply plan progress to all stakeholders. Builds and maintains positive working relationships with customers, co-workers and functional areas to accomplish project objectives.
- Reviews and tracks manufacturing documentation required for submissions to regulatory authorities. Supports regulatory filings, submissions, and responses.
- Performs and supports clinical site, depot or CMO audits as required.
- Supports management with implementation of departmental strategies and policies.
- Other tasks as assigned.
Education & Experience
- BS required, Master’s preferred in life science, or related field (or equivalent experience)
- 6+/8+ years experience in GMP supply chain or pharmaceutical program management at a CRO and/or pharmaceutical/biotech organization.
- Proven experience in Clinical Supplies packaging, labeling, distribution, supply chain and project management.
- Certificate in Supply Chain Management Program preferred
Knowledge and Competencies
- Ability to work independently to execute strategic plans
- Tracks budgets and escalates variances to senior management and finance.
- Understanding of GMP/GCP/GLP regulations and standard pharmaceutical industry procedures
- Demonstrated knowledge of production planning techniques and tools to manage supply plans and material inventories.
- Hands on experience with Interactive Web Response System (IVRS/IWRS) clinical supply software
- Customer service focused
- Open and transparent communication skills (verbal and written)
- Solid organizational and time management skills
- Project management skills and computer proficiency
- Experience with: MS Office Suite
- Ability and willingness to travel 20% of the time (internationally and domestically)
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate. May be required to travel by plane or car.
This position requires working with biological and/or chemical hazards.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
$128k-$185k, bonus, 10% 401k, RSU & Stock Options