Sr Manager- Qc Validation Transfer And Registration For Biochemistry

Biogen

Research Triangle Park, NC, United States
$131,000.00-$175,000.00; bonus/equity: short term ...
Biologics analytical method development
Gmp compliance and regulations
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

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.
  • 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.
  • 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, and life insurances, fitness programs, disability insurance, paid time off, and a 401(k) program with company match.

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.

Salary

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

Skills & Requirements

Must-have

  • Biologics analytical method development
  • GMP compliance and regulations
  • Regulatory filings and health agency responses
  • Project prioritization and resource management
  • Cross-functional team leadership

Nice-to-have

  • Pioneering spirit and commitment to excellence
  • Building high-performing teams
  • Conflict resolution and performance management
  • Continuous process improvement

Key Requirements

  • Minimum 10 years of experience in cGMP biotech/pharmaceutical industry
  • Bachelor's degree in a relevant scientific field (Master's or PhD preferred)
  • Expertise in large molecule (biologics)
  • In-depth knowledge of GMP and pharmaceutical industry regulations
  • Extensive knowledge of analytical method validations and transfers
  • Proven leadership and team management experience

Work Rights

Not specified

Tailored Resume

Cover Letter