What are the responsibilities and job description for the Manufacturing Associate Scientist (Saranac Lake, NY) position at CEDENT?
Summary:
The Manufacturing Associate Scientist plays a key role in supporting the development, enhancement, and commercialization of new and existing products as well as assisting in the implementation of ISO 9001/17034 and other relevant standards or regulatory requirements. They support analytical and product development efforts by assisting in the execution of new products and testing services, which includes communication with clients and key stakeholders to ensure alignment and successful outcomes. This position performs laboratory experiments under the guidance of senior staff, including drafting and executing protocols, analyzing results, and identifying potential issues. They recommend and implement solutions, contribute to the development of innovative techniques, and collaborate with cross-functional teams to ensure project goals are met.
Key Accountabilities and Responsibilities:
The Manufacturing Associate Scientist plays a key role in supporting the development, enhancement, and commercialization of new and existing products as well as assisting in the implementation of ISO 9001/17034 and other relevant standards or regulatory requirements. They support analytical and product development efforts by assisting in the execution of new products and testing services, which includes communication with clients and key stakeholders to ensure alignment and successful outcomes. This position performs laboratory experiments under the guidance of senior staff, including drafting and executing protocols, analyzing results, and identifying potential issues. They recommend and implement solutions, contribute to the development of innovative techniques, and collaborate with cross-functional teams to ensure project goals are met.
Key Accountabilities and Responsibilities:
- Supports all activities associated with the development, enhancement, and execution of new and existing products and testing services
- Manages laboratory experiments under the guidance of senior staff including, but not limited to, the preparation and execution of protocols, authoring reports and presentations, and assisting in the drafting of manuscripts
- Assists in the management of manufacturing and scale-up of commercial products, ensuring that they meet quality control standards and regulatory requirements
- Assists in the setting up and management of reliable supply chain to handle raw materials, production, distribution, and post-sale support.
- Supports the Quality department in implementing and maintaining ISO 9001 (Quality Management System) and ISO 17034 (General Requirements for the Competence of Reference Material Producers) and any other relevant standard or regulatory requirements.
- Implements daily operations of assigned projects including SOP development as appropriate
- Works closely with Quality to ensure all efforts are in alignment with regulatory requirements as well as BTL policies and procedures
- Reviews research findings and data trends, offering practical insights and suggesting ways to improve tools, methods, or experiments to make them more accurate and effective
- Coordinates and manages activity and project resource schedules
- Works independently on collection of data and analyzes research results
- May co-author publications and may co-present results at meetings or conferences
- Guides and mentors staff
- Responsible for maintaining detailed laboratory records of all activities
- Since they function as part of a collaborative and dynamic team, Associate Scientists must demonstrate strong interpersonal skills
- Additional duties as assigned
- Ability to adhere to a standard timeline and escalate actions appropriately for resolution in a timely manner
- Proactively communicates progress and furthers understanding amongst colleagues and supervisors
- Ability to meet testing timelines in a reliable and efficient manner
- Strong critical thinking and problem-solving skills required
- Must have a drive to advance scientific development in a dynamic, team-oriented environment
- Ability to foster a culture of accountability, collaboration, and excellence within the team
- Ability to adhere to a standard timeline and escalate actions appropriately for resolution in a timely manner
- Drafts and updates SOPs and training materials
- Subject matter expert in respective field
- A BS/BA degree from an accredited college/university in Molecular Biology, Cell Biology, Microbiology, Biochemistry or related field; Master’s degree preferred. Equivalent combination of education, training and experience may be substituted.
- A minimum of 3 years’ laboratory and/or manufacturing experience working in CGMP and/or ISO 9001 certified organization is required
- Working knowledge of ISO 9001 and ISO 17034 is required
- Creative and able to adapt quickly to change
- Strong communication skills and the ability to work independently with minimal direction
- A results-oriented team player
- Proficient with Microsoft Office Suite or related software
- Ability to work for prolonged periods sitting on a chair and working at a computer/desk.
- Ability to lift up to 25 pounds and stand for prolonged periods.
