The Senior Specialist will complete the principal duties and responsibilities outlined below. Reporting on findings, trends, and observed issues related to Environmental Conditions/Environmental Monitoring. Working in collaboration with leadership and junior staff, the Senior Specialist will participate in the development, implementation, and execution of critical cleanroom contamination control strategies. Activities may include coordination/ scheduling/performance of routine environmental monitoring (EM), managing 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 Senior Specialist will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion.
Schedule: Fulltime (Benefits Eligible)
Locations: Andelyn Plasmid's Center
575 Children's Crossroads
Columbus, Ohio 43215
Principal Duties and Responsibilities
- Coordinate routine environmental conditions / environmental monitoring sampling, and execution of sampling as necessary.
- Analyze data summaries for quarterly environmental conditions trending reporting – scope may include but is not limited to, microbial environmental monitoring, non-viable particle monitoring, temperature, and differential pressure.
- Monitor Building Management System (BMS) for cleanrooms and notify management of any adverse trends or alarms.
- Manage Real Time Monitoring System (LMS Pharma, LMS Pro, and LMS Express) for a particulate counter.
- Identifies and initiates an investigation of adverse environmental conditions / environmental monitoring trends.
- Participates in cross-functional quality event investigations related to environmental conditions / environmental monitoring.
- Author/revise/review GxP documentation related to environmental conditions / environmental monitoring and associated reporting and trending practices – documentation may include but is not limited to, standard operating procedures, work instructions, technical protocols, and technical reports.
- Exercise discretion, judgment, and personal responsibility
- Demonstrate a high level of integrity.
- Maintain a positive attitude.
- Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF
- Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
- Attention to detail in all job functions.
- Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
- Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff.
- Work on specific measurable objectives requiring operational planning skills with little direct supervision.
- Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of the team and goals.
- Documentation of all activities performed according to SOPs.
- Make decisions based on established procedures.
- Moderate involvement in audits
- Mentoring and professional development of staff
- Other duties as assigned+
Knowledge, Skills, and Abilities Required
- Must possess a relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred.
- Five years relevant (w/4 YR deg) OR two years (w/Masters)
- Strong understanding of GxP is required.
- Experience with quality event investigation is required.
- Experience with microbiology and/or monitoring cleanroom environmental conditions is preferred.
- Experience in biologics or gene therapy is required.
- Experience in highly regulated fields preferred.
- Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
- Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
- Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
- Must possess a client-focused mindset in daily tasks.
- Must possess prior experience handling confidential information and the ability to maintain confidentiality.
Minimum Physical Requirements
Frequently Walking/Standing/Stooping
Occasionally Talking on the phone or in-person
Frequently Typing on a computer keyboard
Ability to occasionally lift 20 - 30 lbs.
Ability to wear cleanroom gowning and other PPE regularly. 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, 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. Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.Andelyn may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn. If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemptions may be considered depending upon the specific job duties