Sr Manager- Qc Validation Transfer And Registration For Biochemistry

Biogen

Research Triangle Park, NC, US
Base: $131,000.00-$175,000.00; bonus/equity: short...
Analytical method development and validation
Biologics (large molecule) expertise
Regulatory filings and health agency responses
The Senior Manager is responsible for leading the VTR Biochemistry team, focusing on strategy, operations, and cross-functional alignment for analytical method development, validation, transfer, and registration

Job Summary

  • The Senior Manager is responsible for leading the VTR Biochemistry team, focusing on strategy, operations, and cross-functional alignment for analytical method development, validation, transfer, and registration.
  • This role involves preparing and reviewing regulatory filings, responding to health agency requests, and managing project prioritization, timelines, resources, and budgets.
  • Biogen offers a full and highly competitive range of benefits designed to support employees' well-being, including medical, dental, vision, and a 401(k) program with company match.

Matching Summary

The Senior Manager is responsible for leading the VTR Biochemistry team, focusing on strategy, operations, and cross-functional alignment for analytical method development, validation, transfer, and registration.

Salary

Base: $131,000.00-$175,000.00; Bonus/Equity: Short term and long-term incentives, cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life insurances, Fitness & Wellness programs, Disability insurance, paid time off, holidays, 401(k) match, ESPP, tuition reimbursement

Skills & Requirements

Must-have

  • Analytical method development and validation
  • Biologics (large molecule) expertise
  • Regulatory filings and health agency responses
  • GMP compliance and quality standards
  • Project prioritization, timelines, resources, and budgets

Nice-to-have

  • Cross-functional alignment
  • Risk-based approach
  • Best practices for process improvement
  • High-performing team building
  • Conflict resolution and performance management

Key Requirements

  • Bachelor's degree (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 team management

Work Rights

Not specified

Tailored Resume

Cover Letter