Director, Supply Chain and Logistics (Clinical and Commercial) 1367624

Location:  Cambridge, MA (Hybrid)
Science: Small Molecule Therapeutics

Therapeutic Area: Undisclosed

Job Overview: Coordinate and lead pharmaceutical supply chain activities including review of study protocols, design of labels, preparation of packaging and labelling contracts, and forecasting and ordering supplies.

Responsibilities:

• Oversee the Global Supply Chain and Logistics including the strategy, budget, planning, timelines, risk-mitigation, and forecasts for upcoming commercial program.
• Provide oversight of logistics, labeling, packaging, distribution at CROs for all clinical assets.
• Lead planning and implementation of commercial supply activities including secondary packaging, artwork, labeling, serialization, logistics, 3PL distribution.
• Collaborate with Commercial to ensure strategy, timelines, risk mitigation plans for a successful global commercial launch
• Responsible for establishing and overseeing Sales & Operations Planning process for commercial supplies.
• Lead inventory management / ERP implementation efforts and subsequently maintain data within ERP as it relates to supply chain and inventory management
• Responsible for functional SOPs, PAI readiness etc. in collaboration with Quality Assurance

Requirements:

• A minimum of 10+ years of Clinical Supply / Clinical Packaging / Project Coordination experience in the pharmaceutical industry or CRO
• Knowledge of cGMPs and relevant global regulations is essential
• Demonstrates a comprehensive understanding and knowledge of the entire Investigational Product and Commercial Supply Chain, IRT requirements, and cost drivers
• Well-versed with regulatory requirements for INDs and NDAs and global GMPs and GCPs
• Excellent interpersonal, oral and written communication skills for effectively interfacing with suppliers, CMOs and internal stakeholders 

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

jditalia@stratacuity

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.