Senior Manufacturing Specialist - Pharmaceuticals
Menlo Park, CA
A pharmaceutical company is seeking a Sr. Manufacturing Specialist to join the team!
As the Sr. Manufacturing Specialist - Pharmaceuticals you will be responsible for post finished goods release functions related to managing supplies for investigational drug products including some procurement, warehousing, distribution, returns and planning for domestic/global demand functions. This position ensures that all clinical trials have timely and adequate supply for administration to patients. This role will also be responsible for global logistics of all commodities associated with the Manufacturing department including arranging, shipping document generation and tracking to final delivery.
- Oversee all global logistic activities from interacting with logistic vendors to shipment arrangement, generation of proper shipping documents, tracking shipments while in transit to ensure timely delivery.
- Manage all clinical temperature excursions from shipment to trial site storage
- Extensive knowledge and experience with Interactive Response Technology (IRT) Systems particular to the role of the Drug Supply Manager while working with the clinical teams, including system modifications where needed
- Generate key drug accountability trackers and logistic performance metrics
- Interact with study teams to ensure appropriate information is filed for each study’s Trial Master File (TMF)
- Drives proper and timely disposition of materials for shipment to designated warehouses
- Monitors IP expiry data and informs Supply Chain colleagues and Clinical Operations of pending IP expiry and alternative inventory availabilities
- Partners with key internal stakeholders (including Quality Assurance, Clinical Operations and Regulatory Affairs) and external vendors to ensure supplies are labelled and released for clinical site shipment to support domestic/global clinical trials
- Assists in the development of supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Achieves operational objectives by providing information and recommendations to strategic plans and Budget reviews
- Assists in the administration of supply agreements and ensure compliance of these agreements
- Monitoring of benchmarks and identification of trends and problems
- Assists in the development of standard operating procedures for Supply Chain operations
- Domestic or international travel may be required per business needs
- BS/BA degree in related discipline and at least 5 years of related experience; or, MS/MA degree in related discipline and at least 3 years of related experience
- Additional specific qualifications in clinical supplies demand and logistics/ or planning management including and APICs, CPIM, and related processional certifications preferred
- Working knowledge of cGMPs and familiar with US and EU regulations
- Working knowledge of drug development process (Phase I-IV)
- Working experience with Interactive Responses Technology (IRT) Systems is a must
- 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
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule format
- Comfortable in a fast-paced small development company environment
- Proficient in Microsoft Outlook, Word and Excel
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.