Sr Manager- Qc Validation Transfer And Registration For Biochemistry

Biogen

Research Triangle Park, NC, United States
$131,000.00-$175,000.00; bonus/equity: cash bonus ...
Analytical method development and optimization
Method validation and transfer
Regulatory filings and health agency responses
The Senior Manager will lead the VTR Biochemistry team, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products

Job Summary

  • The Senior Manager will lead the VTR Biochemistry team, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products.
  • Responsibilities include preparing and reviewing regulatory filings, responding to health agency requests, managing project prioritization, timelines, resources, and budgets, and ensuring compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP).
  • Biogen offers a full and highly competitive range of benefits designed to support employees’ and their families physical, financial, emotional, and social well-being, including medical, dental, vision, life insurances, and a 401(k) program with company matched contributions.

Matching Summary

The Senior Manager will lead the VTR Biochemistry team, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products.

Salary

$131,000.00-$175,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, Paid time off, Holidays, 401(k) matching, ESPP, Tuition reimbursement

Skills & Requirements

Must-have

  • Analytical method development and optimization
  • Method validation and transfer
  • Regulatory filings and health agency responses
  • GMP compliance and quality standards
  • Biologics (large molecule) expertise

Nice-to-have

  • Risk-based approach
  • Cross-functional alignment
  • Process improvement
  • Team leadership and mentorship
  • Conflict resolution and performance management

Key Requirements

  • Bachelor's degree required; Master's or PhD preferred
  • Minimum 10 years of experience in cGMP biotech/pharmaceutical industry
  • Extensive knowledge of analytical method validations and method transfers
  • Proven experience in leadership role with strong team management track record

Work Rights

Not specified

Tailored Resume

Cover Letter