Senior Manager, Scientific Affairs
About The Position
The Senior Manager role in Scientific Affairs will serve as an individual contributor. The role requires a strong understanding of regulatory requirements (e.g., FDA, ICH, ISO, GMP) applicable to sterile injectables. Strong science and risk-based thinking is essential to the role. You will be involved in developing, leading, and managing multiple scientific projects relating to parenteral packaging and delivery demonstrating their to suitability for intended use. You will provide scientific leadership and oversee the design of experiments, apply knowledge across multiple disciplines to generate insights applicable to both scientific and non-scientific audiences. Engaging externally as a West scientific representative and or a subject matter expert with customers, regulatory authorities, and/or other key opinion leaders, is essential to this role.
Requirements
- Bachelor's Degree or equivalent experience in the field of Science, Technology, Engineering or equivalent
- Minimum 10 years required in drug product packaging, or a scientific/regulatory affairs role within the pharmaceutical, biotechnology, or medical device industry.
- Possess excellent communication and presentation skills
- Has the ability to translate complex science into simple actionable plans that provide scientific guidance to internal teams that contribute to business success
- Adaptable to changes in the work environment, managing competing demands and dealing with frequent changes, delays, or unexpected events
- Ability to effectively communicate and comprehend complex ideas and concepts
- Be proficient in Microsoft Office
- Be aware of all relevant SOPs, as per Company policy, as they are related to the position covered by this Job Description
- Ability to comply with the company’s safety and quality policies at all times
Nice To Haves
- Pharmaceutical or life science industry experience recommended
Responsibilities
- Understand requirements and intended use of packaging & delivery systems, analytical testing and data correlation related to the pharmaceutical market
- Develop and implement scientific strategies and thought leadership aligned with business objectives
- Establish communities of practice, advancing knowledge and exchanging best practices
- Provide scientific guidance to internal teams and contribute to strategic planning
- Translate complex science into business strategy
- Interpret and communicate scientific data to internal and external audiences
- Engage with external stakeholders including regulatory agencies and business partners
- Build and maintain relationships with key opinion leaders and external scientific experts
- Represent the company at standard setting organizations, scientific meetings, conferences, and industry events
- Attend scientific conferences and meetings to stay up to date on the latest research and advancements
- Leverage analytical thinking for problem-solving
- Conduct independent research to support various projects, read various studies and scientific papers to gather accurate and relevant information
- Stay current with industry standards and compliance requirements
- Work collaboratively across departments
- Provide training and education to internal teams about current scientific topics and research trends
- Educate and lead scientific exchanges, technical discussions, and advisory boards with various partners to obtain background on requirements and identify opportunities for market leadership
- Adhere to regulations, policies, work procedures, and safety rules
- Perform other duties as assigned based on business needs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
