Sr Manager- QC Validation Transfer and Registration for Biochemistry
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Job Location:
Durham County, NC - USA
Monthly Salary:
$ 131000 - 175000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
This position is on site at our Research Triangle Park NC facility and would include 20-30% travel domestic and internationally
About This Role
The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site 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 at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization timelines resources and budgets and ensures compliance with global analytical strategies CAPA change control deviations and quality standards (GMP). The senior manager approves reports analyzes data and establishes new or alternative analytical methods.
What Youll Do
Define strategy review regulatory filings respond to agency inquiries mitigate risks and manage global change controls. Support audits and inspections
Develop solutions for technical and compliance challenges; apply best practices to improve processes and services
Lead and mentor a diverse team of scientists
Provide technical and compliance support; resolve issues to maintain business and manufacturing schedules
Build a high-performing team; Set clear goals conduct reviews and provide feedback
Oversee complex projects approve technical documents and coordinate with QA Regulatory Validation and other QC teams
Act as interim VTR Biologics leader when needed
Required Skills
Bachelors degree Masters or PhD preferred in molecular biology cell biology virology biochemistry or related field
Minimum 10 years of experience in cGMP biotech/pharmaceutical industry within quality
Expertise in large molecule (biologics)
Possesses in-depth knowledge of GMP and pharmaceutical industry regulations and requirements including but not limited to FDA EMA ICH USP EP JP and CHP
Extensive knowledge of analytical method validations and method transfers
Ability to manage and support multiple complex activities simultaneously
Demonstrated strong critical thinking and problem-solving skills
Strong verbal and written communication skills with the ability to effectively communicate with all levels of management internally and externally
Leads and mentors a diverse team promoting professional growth and development
Proven experience in leadership role with a strong track record of team management
Experience in conflict resolution and performance management
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
- Medical Dental Vision & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
Manager
Key Skills
- Account Management
- Apache Web Server
- Jpa
- ABAP
- Community Support
- Islamic Banking
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
