Director, Industry Specialty Services

Job Summary:

Under the supervision of a Managing Director, the Director, Industry Specialty Services will provide support for consulting projects in appropriate CMC- or regulatory-related fields, including, but not limited to, product development, bioprocess development, analytical and formulation development, manufacturing strategy and operations, quality control and quality assurance, regulatory, compliance, and market research. This role may be a project authority and is expected to actively participate in client interactions as needed. In addition, the Director will be responsible for internal firm projects and initiatives, such as the bioTRAK database, process economic models, or company library.

This position will work a sporadic and fluctuating work schedule.

Job Duties:

• Provides consulting services in the areas of CMO selection, process development, analytical and formulation development, validation, manufacturing strategy and operations, cost of goods modeling, database research, and program management, independently or under the direction of the Managing Director
• 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
• Conducts market research, technology assessments, and due diligence reviews and interacts with clients during project calls or meetings to present findings independently
• 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
• Provides support in drafting and reviewing client-specific regulatory and quality documentation and in auditing CMOs and CROs under the supervision of the Lead Auditor.
• Identifies interactions with clients or on behalf of clients requiring the involvement of Managing Directors and actively solicits this additional resource
• Provides necessary support for internal Firm operations and initiatives (i.e., BPTG Projects):
  • Writes blogs and develops and implements surveys
  • Supports BPTG's business development efforts, including representing BPTG at conferences and trade shows
  • 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:

• Bachelors degree in a scientific or engineering discipline relevant to the life sciences industry, required
• Advanced degree, preferred

Experience:

• Seven (7) years' experience in the pharmaceutical or biopharmaceutical industry in a CMC related role supporting development, manufacturing, or quality of biopharmaceutical or biologic products, preferred
• Experience as a major contributor to regulatory submissions, preferred

Software:

• Proficient in the use of Microsoft Office Suite, specifically Excel, Word, and PowerPoint, required

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
• Proven 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