Sr. Manager Clinical Packaging & Labeling
Menlo Park, CA US
A pharmaceutical company is seeking a Sr. Clinical Packaging & Labeling Manager to join their team!
As Sr. Manager, Clinical Packaging & Labeling, you will be responsible for packaging, labeling, and IRT activities to ensure continuous drug supply to all global clinical trials. This position will report to the Director, Supply Chain.
- Manage packaging and open/blinded labeling to ensure the timely release of drug supply for the company's global clinical trials
- Manage clinical drug supply in IRT, including expiry extensions, release of newly packaged drug, and depot transfers
- Ensure inventory levels are maintained at depots and sites
- Partner with key stakeholders (eg. Quality Assurance, Clinical Operations, Regulatory Affairs) and CMO’s to ensure the timely release of drug supply
- Develop and implement appropriate Supply Chain SOPs
- Generate effective tracking tools and performance metric reports
- Lead periodic production schedule meeting
- Domestic or international travel may be required
Preferred Skills, Qualifications and Technical Proficiencies:
- Working experience with global clinical trials and IRT systems is a must
- Working knowledge of cGMPs and familiarity with US and EU regulations
- Working knowledge of drug development process (Phase I-IV)
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative, fast-paced, dynamic environment
- Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines
- Strong attention to detail with excellent follow-up
- Proficient in Microsoft Outlook, Word, Excel, PowerPoint
Preferred Education and Experience:
- BS/BA degree in Life Science or a closely related field
- 6-8 years of experience in a pharmaceutical or biotechnology company
- ASCM CPIM/CSCP certifications preferred
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.