Job Description

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

Join us at BDO, where you will find more than a career, you’ll find a place where your work is impactful, and you are valued for your individuality. We offer flexibility and opportunities for advancement. Our culture is centered around making meaningful connections, approaching interactions with curiosity, and being true to yourself, all while making a positive difference in the world.

At BDO, our purpose of helping people thrive every day is at the heart of everything we do. Together, we are focused on delivering exceptional and sustainable outcomes and value for our people, our clients, and our communities. BDO is proud to be an ESOP company, reflecting a culture that puts people first, by sharing financially in our growth in value with our U.S. team. BDO professionals provide assurance, tax and advisory services for a diverse range of clients across the U.S. and in over 160 countries through our global organization.

BDO is the first large accounting and advisory organization to implement an Employee Stock Ownership Plan (ESOP). A qualified retirement plan, the ESOP offers participants a stake in the firm’s success through beneficial ownership and a unique opportunity to enhance their financial well-being. The ESOP stands as a compelling addition to our comprehensive compensation and Total Rewards benefits* offerings. The annual allocation to the ESOP is fully funded by BDO through investments in company stock and grants employees the chance to grow their wealth over time as their shares vest and grow in value with the firm’s success, with no employee contributions.

We are committed to delivering exceptional experiences to middle market leaders by sharing insight-driven perspectives, helping companies take business as usual to better than usual. With industry knowledge and experience, a breadth and depth of resources, and unwavering commitment to quality, we pride ourselves on:

• Welcoming diverse perspectives and understanding the experience of our professionals and clients
• Empowering team members to explore their full potential
• Our talented team who brings varying skills, knowledge and experience to proactively help our clients navigate an expanding array of complex challenges and opportunities
• Celebrating ingenuity and innovation to transform our business and help our clients transform theirs
• Focus on resilience and sustainability to positively impact our people, clients, and communities
• BDO Total Rewards that encompass so much more than traditional “benefits.” Click here to find out more!

*Benefits may be subject to eligibility requirements.

Equal Opportunity Employer, including disability/vets