Staff Scientist Research
7 days ago
Duties and Responsibilities
Under general direction with limited supervision and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
- Lead liquid culture (fermentation) process development and implementation
- Lead studies for enzyme purification and activity control
- Work closely with manufacturing engineers to integrate biological indicator manufacturing processes and systems
- Lead R&D and life cycle management activities; provide guidance to other scientists as needed
- Lead design changes for marketed products such as manufacturing steps, process, or design validations, product testing, marketing analysis ensuring robust processes that meet CTQs
- Lead or support and document technical investigations, NCs, or CAPAs associated with biological indicator or other consumable processes, systems, or products according to GMP principles and procedures
- Identify, perform experiments, and implement process, cost, yield, scrap, etc. improvements to biological indicator manufacturing process in collaboration with operations department
- Execute product and test method development and validation, in support of production commercialization for medical device reprocessing and infection control projects
- Train and provide guidance to junior-level scientists either under direct or indirect supervision
- Provide support for CIPs, new product introduction, and change management projects related to the product lines focusing on microbiology (e.g., biological indicator)
- Demonstrate proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements
- Performs other duties assigned as needed
Other Duties
- Prepare and assist of strategic vision or plan by collaborating with other cross functional departments
- Communicate business related issues to management timely
- Meet and ensure adherence to compliance standards including monitoring, compliance with the relevant guidance documents from such as ISO, QSR, or FDA, and in preparation of documentation demonstrating compliance
Qualifications - Education & Experiences
Minimum experience and education for this position is a bachelor’s degree with 7-9 years of applicable experience in a scientific discipline such as Microbiology, Biochemistry, Biomedical Engineering or a closely related field, or a master’s degree with 5-7 years of applicable experience, or a PhD with 2-4 years of applicable experience.
- At least 7 years of experience in the Medical Device or other GxP-regulated industry preferred
- At least 5 years product development and/or manufacturing experience, including technical operations, technical transfer, or technical assurance positions preferred
- At least 2 years of supervisory experience with one or more direct reports strongly preferred
- Additional experience and familiarity with IQ/OQ/PQ, method development and validation, and PV processes and requirements preferred
- Professional experience and understanding of QSR, FDA, and ISO guidelines preferred
Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
- Fermentation on microbial liquid culture in bioreactors and its upstream and downstream process (filter purification) experience are strongly preferred
- Hands-on experience supporting bacterial endospore production, biological indicator manufacturing and terminal sterilization, and a thorough understanding of microbiology sterilization principles is preferred
- Experience working in a regulated industry, where design controls per FDA Quality System Regulations and ISO 13485 are applied is preferred
- Capability to develop study protocols, analyze data, and propose theoretical solutions/explanations for sterilization or biological indicator manufacturing studies (e.g., D-value, stability testing). Sound statistical analysis is required (i.e., Minitab, etc.); provide guidance and supervisory role to microbiology associates conducting hands-on testing for Biological Indicator manufacturing (e.g., titers, D-value, stability testing) or sterilization (e.g., D-value and cycle validation)
- Capability to work with individuals that have diverse technical competencies (i.e., engineers, chemists, quality engineering, etc.)
- Knowledge of AAMI/ISO standards in the area of biological indicators and/or terminal sterilization
- Demonstrated experience in process development and/or validation preferred
- Knowledge of analytical techniques and experience with analytical method development, validation, and transfer preferred
- Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean) is preferred
- The successful candidate must be self-driven, innovative, have strong critical thinking and problem-solving skills, and capable of working independently or in a team
- Must possess effective oral and written skills as well as demonstrate the ability to effectively function in a cross-functional team environment
Responsibilities for Others and Internal Interactions
- This person may supervise or train junior scientists
- Collaborate with Operations, Quality Assurance, Supply Chain, and Regulatory Affairs partners
External Interactions
- Ability to elevate inquiries from customers of ASP, government agencies or auditors, when occurs, per ASP standard operating procedures
- Leads communication with external suppliers, service providers, and manufacturers
- Collaborates with external laboratories to form study plans, execute the studies, and analyze the results
- Supports VOC (voice of customers) collection and translates VOC to generate product concept
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