GENERAL DESCRIPTION
Andelyn Biosciences is an industry-leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope on the minds of every patient and their families. Andelyn is primarily a full-service manufacturer of Adeno Associated Virus (AAV). We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality.
The Facility Senior Specialist (Environmental Monitoring) will complete the principal duties and responsibilities outlined below. Providing overall facility guidance on findings, trends, and observed issues related to Environmental Monitoring. Working in collaboration with leadership and junior staff, the Senior Specialist will lead the development, implementation, and execution of critical cleanroom contamination control strategies. Activities may include coordination/scheduling/performance of routine environmental monitoring (EM), managing EM data reporting and analysis, investigation of quality events, development and implementation of corrective action / preventative action (CAPA), management of project timelines/tasks, authoring technical and procedural documents, as well training and mentoring junior staff. The Facility Senior Specialist will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion.
PRINCIPAL DUTIES AND RESPONSIBILITIES
1. Author/revise/review GMP documentation related to environmental monitoring and associated reporting and trending practices – documentation may include but is not limited to, standard operating procedures, work instructions, technical protocols, technical reports.
2. Analyze data summaries for quarterly EM trending reporting.
3. Present quarterly EM trending findings to Andelyn Quality Council.
4. Identifies and initiates an investigation of adverse EM trends.
5. Contributes as a key driver for executing investigations relating to EM out of specification results and driving the identification of root cause and implementation of CAPAs.
6. Execute routine EM sampling as needed.
7. Support constant state of inspection readiness, support audit activities, and interact daily with internal and external auditors as SMEs.
8. Cultivate a diverse and collaborative team environment.
9. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.
10. Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
11. Demonstrate a high level of integrity.
12. Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF.
13. Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
14. Maintain a positive attitude.
15. Other duties as assigned.
REPORTING RELATIONSHIPS
Reports to: Facility & Contamination Control Leadership – Andelyn Biosciences
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED
1. Requires a relevant four-year degree with at least six years of relevant experience in pharmaceutical environmental monitoring / microbiological testing.
2. Strong understanding of cGMPs is required.
3. Has in-depth working knowledge and understanding of microbial environmental monitoring – a basic understanding of non-viable particulate monitoring is desired.
4. Experience with data analysis/trending and technical writing is required.
5. Experience with quality event investigation is required.
6. Experience with microbiology in aseptic manufacturing cleanroom environments preferred.
MINIMUM PHYSICAL REQUIREMENTS
- Typing on a computer keyboard Constantly (0-33%)
- Standing/walking Occasionally (67-100%)
- Lift weight at 30lbs (0-33%)
- Ability to wear cleanroom PPE (80-100%
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision. EOE M/F/Disability/Vet