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Manager, Scientific & Regulatory Affairs 60 views

Manager, Scientific & Regulatory Affairs, Augusta, Georgia, United States, Full-Time

Manus Bio is a next-generation industrial biotechnology company headquartered in Cambridge, Massachusetts that produces plant-based ingredients.  We use a variety of patented and proprietary technologies to engineer microbes for the production of specialty chemicals, such as food ingredients, agricultural chemicals, and pharmaceuticals.  We are seeking a highly motivated Manager, Scientific & Regulator Affairs. This hands-on position requires a desire and ability to work as an integral part of a multidisciplinary team, as well as the demonstration of a high degree of flexibility, creativity, and initiative applied to the various duties and aspects of the position. This person will be expected to play an integral part of Manus Bio’s team located in Augusta, GA.

 

Why work at Manus Bio:

  • Opportunity – For motivated, results-oriented team members, our growth creates opportunities for personal and professional advancement.
  • Accountability – You are given the resources you need to succeed and the freedom to make it happen; in return, we hold each other accountable for our high expectations.
  • Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that come with working on the cutting edge.

 

Responsibilities:

Innovation
Monitor and evaluate and information and data to support safety for regulatory documentation, registration dossiers and risk assessment for products (initial emphasis on food ingredient regulation -low and no calorie natural sweeteners, and Natural Flavor & Fragrance ingredients – FEMA and IOFI.

  • Oversee strategic development and implementation of preclinical/clinical studies to support food ingredient safety
  • Interact with global government agencies to progress and secure ingredient approvals consistent with the commercial strategy.
  • Facilitate and deliver clear and transparent toxicology risk assessment, enabling robust decision making based on updated scientific data and recognized risk assessment methods.
  • Provide regulatory support on all aspects of innovation pipelines and existing products and provide timely communication of regulatory and scientific events to business team.
  • Secure insights from various data sources, proactively leveraging knowledge to support corporate growth agendas.

External Engagement
Engage with scientific experts, external scientific organizations, and trade industry groups to advocate for science that supports ingredients and products.

  • Review, navigate and advise globally on competent authority requirements, and scientific and industry positions that impact the portfolio.
  • Participate in external scientific forums when appropriate; demonstrate thought leadership in the scientific and regulatory community amongst customer and influential organizations.

 

 Compliance
Understand the implications of regional events that impact the Industrial markets for the product portfolio, including new legislation, global regulations, emerging safety data, etc.

  • Track emerging science on new food safety risks, toxicological risk assessment methodologies and food safety issues.
  • Develop effective operational plans and secure endorsement from key stakeholders, mobilizing the right resources to ensure successful execution.

 

Required Qualifications:

  • PhD/MS in Applied Biological Sciences, Nutrition, Food Science, Food Safety/ Toxicology, or other relevant subjects.
  • 5-10+ years of experience in scientific and regulatory affairs, with experience in the food industry, or government food and agriculture regulation, and an understanding of related issues
  • Proven successes in gaining global regulatory approvals for GRAS substances, novel foods, food additives, Flavor materials and fragrance materials.
  • Experience on regulatory approvals of sweeteners would be beneficial.
  • Experience of the US, EU/ EFSA and Codex/ JECFA regulatory and risk assessment processes as minimum.
  • Critical thinker with a strong ability to interpret science and communicate the impact and implications of potential regulations, to both technical and business audiences.
  • First class communication skills; ability to communicate complex scientific and technical regulatory issues related to food ingredients and consumer products.
  • Proven staff management experience and success across multi-cultures. Can build sustainable relationships with staff reports, team members, internal partners, and nurture external relationships that deliver value for the business.
  • Strong ability to influence and negotiate in a multi-cultural environment, across departments and sectors.
  • Experience of global risk assessment and approvals for natural, non and low-calorie sweeteners.
  • A thought leader on best practices, scientific integrity, and transparency of working with an established network of contacts and external engagement profile with industry and influencers.
  • Agility to be strategic when needed, but also to be fully engaged in day-to-day executional work.
  • Technical know-how and ability with online systems for product data management.

Preferred Working Style:

  • We seek a well-organized, self-motivated, creative individual who is able to both lead and manage multiple projects
  • Must work independently, prioritize and be detail and deadline oriented with excellent time and project management
  • Must be a positive team member with a collaborative spirit who can navigate teams with ease.
  • An entrepreneurial spirit with a passion for science and the food & flavor
  • Flexible with day-to-day duties and able to thrive in a start-up
  • Must uphold highest professional and ethical standard

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Company Information
  • Active Jobs 24 Jobs
  • Company Address 1030 Massachusetts Ave #300, Cambridge, MA 02138
  • City Cambridge
  • Location Massachusetts
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