qPCR Laboratory and Biologics Risk Manager
3 weeks ago
Job Location
Scientific Protein Laboratories - Waunakee, WI
Description
JOB SUMMARY
Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a qPCR Laboratory and Biologics Risk Manager.
This position is responsible for overseeing the viral testing program and PCR groups within the QC Department and serves as the principal expert on all technical and regulatory matters associated with the company's infectious agent risk management programs supporting pharmaceutical or medicinal product business interests. The incumbent is expected to have a broad perspective on specific technical and regulatory issues that are relevant to Company objectives. This position will develop, implement, and set priorities and communicate the Company's infectious agent risk management strategy.
The Manager is the SPL site lead for cutting-edge molecular technology assays and risk management for potentially infectious agents associated with biologically sourced medical products. In this role the Manager is responsible for developing and implementing quality control assays supporting release testing of products manufactured at SPL. Further, they are responsible for developing tools and methods for surveying environmental factors and risks associated with biologically sourced raw materials.
Responsibilities include:
- Provide strategic direction and tactical focus to the infectious agent risk management approach across the business.
- Provide strategic and tactical leadership to integrate risk management plan and regulatory requirements into pharmaceutical and biological development programs.
- Develop and implement communication and training programs in connection with the Company's infectious agent risk management plans, strategies, and processes. Conduct internal and external benchmarking to identify best practices and assist with implementation.
- Function as a liaison between QC and other departments.
- Review and approve studies, protocols, and method validations.
- Prioritize workloads in QC, maintaining balance between routine testing turnaround and special projects.
- Provide guidance to analysts and supervisors running technical projects.
- Assists QA during audits and help respond to customer questions related to QC data.
- Maintain and continuously improve QC testing and systems.
- Epidemiological monitoring for viruses or other pathogens.
- Inactivation studies in support of SPL products or customer specific.
- Quality control testing for pathogens, qPCR, and next generation sequencing.
- Active participation in external technical and regulatory related activities and organizations affecting or impacting the business.
- Develop comprehensive risk management plans within FDA, EU, ICH, or other applicable guidelines.
- Develop risk management programs to identify, mitigate, and control risks due to potential infectious agents (microorganisms, viruses, prions, parasites).
- Use current technologies and science to characterize, quantitate, and define potential risks due to potential infectious agents.
- Develop cutting-edge quality control methods for detection, identification, and controls.
- Design of applicable models, data bases, and other scientifically sound protocols (for example, inactivation studies for verification or validation) or approaches to implement risk management plans.
- Overall leadership as the subject matter expert for one or more departments.
- Leadership in developing strategic plans for pharmaceutical and biologics development that integrate regulatory requirements, guidance, and expectations to facilitate approvals in global markets.
- Education: Advanced degree in a scientific or preprofessional field required (biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, engineering etc.). Advanced degree and post-doctoral or equivalent experience in a scientific or preprofessional field preferred (biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, engineering etc.). Publications in the respective areas preferred.
- Experience: 5 plus years molecular technology experience with a working knowledge of techniques such as qPCR and next generation sequencing. Detailed knowledge in virology, microbiology, parasitology, or other related fields required. 10 plus years extensive molecular technology experience with detailed knowledge of techniques such as qPCR and next generation sequencing. Expert in the field of virology, microbiology, parasitology, or other related subjects as well as publications in the respective area preferred.
WHY JOIN SPL?
Our employees are our success We recruit motivated people, recognize their contributions, and support their development to reach their full potential.
Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more
SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
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