Manager, BPTG

Job Summary:

Under the supervision of a Managing Director, the Manager, BioProcess Technology Group (BPTG) will provide support for consulting projects in biopharmaceutical development, including but not limited to analytical method development, method validation, method transfer, quality control release and stability analysis, and regulatory compliance. This role is expected to actively participate in client interactions as needed. In addition, the Manager will support internal firm projects and initiatives, including thought leadership and firm building.

Job Duties:

• Provides consulting services, independently or under the direction of the Managing Director, in the areas of biopharmaceutical analytical method development, phase appropriate qualification, validation, characterization and quality control release and stability analysis
• Provides support 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 reports, regulatory and quality documentation and in auditing CMOs and CROs under the supervision of the Lead Auditor
• 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
• 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
• 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):
  
  
  
  • Supports BPTG's business development efforts
  • Supports other internal initiatives, such as protocol and report template authoring
  
  

Supervisory Responsibilities:

• Supervises client engagements, maintains client relations, and provides client support
• Oversees assigned Senior Associates and Associates
• Acts as a career advisor to Senior Associates and Associates

Qualifications, Knowledge, Skills, and Abilities:

Education:

• Bachelors degree in Natural Sciences, Bio Engineering, or Life sciences, required

Experience:

• Five (5) or more years of 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, preferred
• In-depth knowledge of or experience developing / qualifying analytical methods such as SE-UPLC, rCE-SDS, nrCE-SDS, icIEF, binding assays and process residual assays (ELISA, qPCR), 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
• Working knowledge of 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 quantitative 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
• Self-motivated and ability to work with minimal supervision
• Ability to collaborate well with others and maintain a flexible mindset