Sr Manager- Qc Validation Transfer And Registration For Biochemistry

Biogen

Research Triangle Park, NC, USA
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 late stage clinical and commercial products

Job Summary

  • The Senior Manager is responsible for leading the VTR Biochemistry team, focusing on strategy, operations, and cross-functional alignment for late stage clinical and commercial products.
  • 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 life insurances, as well as a 401(k) program with company matched contributions.

Matching Summary

The Senior Manager is responsible for leading the VTR Biochemistry team, focusing on strategy, operations, and cross-functional alignment for late stage clinical and commercial products.

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, Paid Maternity and Parental Leave, 401(k) program, Employee stock purchase plan, 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 and resource management

Nice-to-have

  • Mentoring diverse scientific teams
  • Risk-based approach to challenges
  • Improving processes and services
  • Building high-performing teams

Key Requirements

  • Bachelor's degree (Master's or PhD preferred)
  • Minimum 10 years of experience in cGMP biotech/pharmaceutical industry
  • 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

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