Senior Manager, Clinical Supply Chain, BioProcess Technology Group

Job Summary:

The Assurance Senior Manager, Industry Specialty Services, BioProcess Technology Group (BPTG) provides supply chain management support to clients with products in early- and late-stage clinical development including those seeking regulatory approval through validation studies. This role may be a project authority and is expected to actively participate in client interactions as needed. In addition, the Director is responsible for internal firm projects and initiatives, such as the bioTRAK database, process economic models, or company library.

Job Duties:

• Generates and implements supply planning that incorporates clinical timelines, CMC schedules, and sourcing of critical materials
• Works with client resources, third party vendors, and service providers to achieve on-time sourcing, shipping, and delivery of all clinical materials
• Manages and tracks inventory supplies, expiry, and safety supply levels
• Conducts clinical site and vendor audits to ensure accurate inventory supplies and appropriate storage conditions
• Negotiates vendor agreements and similar contracts on behalf of clients to manage supply chain performance
• Maintains regulatory documentation and ensures compliance with all guidelines
• Assesses risk profiles, identifies and ranks potential risks to supply chains, and develops mitigation plans to overcome delays or shortages
• Provides project management and collaboration between stakeholders across the supply chain: clinical sites, suppliers, manufacturers, and shippers
• Generates periodic reports on supply chain status, risk assessments, and performance
• Performs necessary project related tasks within time and budget, consults with project lead to discuss the appropriate action if allotted budget or time is to be exceeded
• Provides support in managing client internal research programs and outside service providers, including tracking and distributing materials, reagents, and/or information as needed between vendors and client sites
• Identifies interactions with clients or on behalf of clients requiring the involvement of Managing Directors and actively solicits this additional resource
• Supports business development efforts to expand revenue generation under the guidance of senior leadership:
  
  
  
  • Actively supports evaluation of new business opportunities including participating in introductory calls with prospects and generating statements of work (SOWs)
  • Utilizes current network of contacts to develop new business opportunities
  • Develops, manages, and expands relationships with active client organizations to increase account penetration
  • Collaborates and provides input towards marketing efforts to increase awareness of BPTG services in the industry
  • Represents BPTG at conferences and trade shows
  
  
• Provides necessary support for internal Firm operations and initiatives (i.e., BPTG Projects):
• Authors articles for publication in journals and presentations for delivery at conferences consistent with enhancing BPTG's reputation as a leading CMC consulting group
  
  
  
  • Supports other internal initiatives, such as developing reports, upgrading internal assets, including the Company's bioTRAK database, COGS and other modeling capabilities, and library
  
  
• Other duties as required

Supervisory Responsibilities:

• Supervises client engagements, maintains client relations, and provides client support
• Oversees assigned Senior Associates and Associates

Qualifications, Knowledge, Skills, and Abilities:

Education:

• Bachelor's degree in Natural Sciences, Bio Engineering, or Life Sciences, required
• Advanced degree, preferred

Experience:

• Seven (7) or more years of experience in the pharmaceutical or biopharmaceutical industry, required
• Five (5) or more years of experience in a clinical or CMC related role supporting clinical operations, procurement, project management, manufacturing, or quality of biopharmaceutical or biologic products, preferred

License/Certification:

• N/A

Software:

• Proficient in the use of Microsoft Office Suite, specifically Excel, Word, and PowerPoint, required
• Experience with project planning tools such as MS Project, preferred

Language:

• N/A

Other Knowledge, Skills, & Abilities:

• Excellent verbal and written communication skills, specifically business/report writing
• Strong analytical and basic research skills
• Solid organizational skills especially ability to meet project deadlines with a focus on details
• Ability to successfully multi-task while working independently or within a group environment
• Ability to work in a deadline-driven environment and handle multiple projects simultaneously
• Ability to follow and apply specific rules and regulations
• Ability to work with minimal supervision