Director, Clinical Supply Chain (Biotech) 1101067
Job Scope and Purpose:
Our Cambridge-based company, focused in controlling gene expression, is seeking an exceptional Supply Chain leader to coordinate and lead clinical supply activities for its ongoing clinical studies. This candidate will independently review clinical study protocols, and will have experience with clinical label design and packaging, and forecasting and ordering of supplies. This hire will coordinate efforts of Clinical Trial Supply Packaging with cross-functional teams to establish plans for the effective distribution of clinical supplies. To learn more about this critical opportunity with an exciting organization, reach out to Kevin Rees today.
Primary Job Responsibilities:
- Develop and implement a Clinical Supply Master Plan for all phases of clinical protocols through timelines, budgets, drug supply forecasts and component requirements
- Track and report on progress of manufacturing and distribution plans, monitoring metrics to understand and optimize supply chain performance
- Manage warehousing, distribution and logistics of clinical supplies shipments
- Coordinate supply requirements for local and international studies, including continuous forecasting, communicating manufacturing needs, and packaging/labeling activity scheduling
- Provide project management to high level CMC activities pertinent to maintaining clinical supplies
- Evaluate customer needs and offer alternatives to accomplish project goals
- Review and update existing SOPs and identify the need for and assist in the establishment of new departmental procedures
Primary Job Requirements:
- At least 6-8 years of Clinical Supply / Clinical Packaging / Project Coordination experience in the pharmaceutical industry or CRO. Bachelors or Masters Degree required, MBA preferred.
- Must have thorough knowledge of cGMPs and relevant global regulations
- Must demonstrate a comprehensive understanding and knowledge of the entire Investigational Product Supply Chain, IRT requirements, and cost drivers
- Must be well-versed with regulatory requirements for INDs and NDAs and global regulatory requirements for GMP and GCP
- Must possess exceptional attention to detail and organizational/writing/presenting skills, with project management experience strongly preferred
- Must be willing to work in a fast-paced, start-up environment with the ability to handle multiple on-going projects
- Ability to travel up to 10% of time
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.
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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.
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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
Packaging And Labeling
Good Clinical Practices (Gcp)