Director, BPTG

Job Summary:

The Director, Bioprocess Technology Group (BPTG), will provide technical, strategic, and regulatory chemistry, manufacturing, and controls (CMC) consulting services to biopharmaceuticals clients of BDO either independently or in collaboration with other BPTG consultants. The Director will provide support for analytical method development, method validation, method transfer, product characterization, quality control release and stability analysis, and regulatory compliance. This role will be expected to actively participate in client interactions as well as support internal firm projects and initiatives.

Job Duties:

• Provides independent and team-based consulting services in the areas of biopharmaceutical analytical method development, phase appropriate qualification, validation, product characterization and quality control release and stability analysis
• Provides comprehensive and independent consulting services in reviewing client-specific analytical data and compiling and analyzing results for inclusion into regulatory and quality documents
• Provides support in drafting and reviewing client-specific analytical protocols and reports, regulatory and quality documentation
• Manages projects according to the statement of work (SOW) and the budget; clearly communicates with team members their roles and responsibilities as well as the applicable budgeted time
• Acts as Project Manager to manage overall client programs as the client’s single point of contact and engages group subject matter experts for input on specific program requirements
• Provides essential quality, regulatory, and compliance guidance, including development of comprehensive CMC regulatory, to support product lifecycle from discovery through commercialization
• Supervises client engagements, maintains client relations, and provides client support
• Provides necessary support for internal practice operations and initiatives
• Leads or participates in business development for the Firm by developing relationships with current and prospective clients, works on expanding current projects to include additional scope, initiates or actively engages in sales calls and in drafting proposals and contracts, attends and speaks at conferences, and contributes to marketing materials
• Supervises client engagements, maintains client relations, and provides client support
• Other duties as required

 

Supervisory Responsibilities:

• Oversees assigned Associates and Senior Associates
• Acts as career advisor to Associates and Senior Associates

 

Qualifications, Knowledge, Skills and Abilities:

Education:

• Bachelor’s degree in Natural Sciences, Bio Engineering, or Life Sciences, required
• Master’s degree or higher, preferred

Experience:

• Ten (10) or more years’ experience in the biopharmaceutical industry, required 
• Experience in a CMC related technical role supporting analytical method development and qualification of test methods for biopharmaceutical or biologic products, required
• Experience developing / qualifying analytical methods, including SE-UPLC, rCE-SDS, nrCE-SDS, icIEF, binding assays and process residual assays (ELISA, qPCR) as well as compendial methods, required
• Experience with bioassays, preferred
• Experience with both analytical development and QC function, preferred
• Experience as a contributor to regulatory submissions, preferred

License/Certifications:

• N/A

Software:

• Proficient in the use of Microsoft Office Suite, specifically Excel, Word, and PowerPoint, required
• Experience with JMP or similar statistical tools, preferred
• Experience working knowledge with AI tools for data compilation and document writing, preferred

Language:

• N/A

Other Knowledge, Skills & Abilities:

• Excellent verbal and written communication skills, specifically authoring analytical documents such as development reports, qualification protocols/reports and characterization reports
• Strong quantita