Supervisor, Manufacturing GMP Cleaning
Company: AveXis Inc.
Posted on: April 17, 2019
OverviewReady to join a team committed to moving gene therapies
into the clinical and commercial settings for patients and families
devastated by rare neurological genetic diseases? AveXis is
advancing cutting-edge science to treat rare and life-threatening
genetic diseases starting with our clinical-stage, proprietary gene
therapy candidate, AVXS-101 (ZOLGENSMA--). We are in the midst of
an incredible journey and are looking for passionate individuals to
join us on this important mission.AveXis, Inc., a Novartis Company
, is a clinical-stage gene therapy company, dedicated to developing
and commercializing novel treatments for patients suffering from
rare and life-threatening neurological genetic diseases. Our
initial product candidate, AVXS-101, is our proprietary gene
therapy product candidate currently in development for the
treatment of spinal muscular atrophy, or SMA, Type 1, the leading
genetic cause of infant mortality, and for the treatment of SMA
Type 2. The U.S. Food and Drug Administration, or FDA, has granted
AVXS-101 Orphan Drug Designation for the treatment of all types of
SMA and Breakthrough Therapy Designation, as well as Fast Track
Designation for the treatment of SMA Type 1. In addition to
developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to
develop other novel treatments for rare neurological diseases,
including Rett syndrome (RTT) and a genetic form of amyotrophic
lateral sclerosis (ALS) caused by mutations in the superoxide
dismutase 1 (SOD1) gene.This position is responsible for
supervising the cleaning team of the ISO classified clean rooms and
associated activities as directed. Primary responsibilities include
supervision of cleaning staff in applying cleaning solution to
floors, ceilings, walls, fixtures, and equipment in conjunction
with the proper cleaning equipment such as mops, wipes, bucket
system, etc. following approved cleaning standard operating
procedure. Individual will be directly responsible for a team of
contractors whose direct responsibilities include performing GMP
cleanings of different ISO clean room rated areas. The
manufacturing supervisor will be the first line of contact to
handle emergencies and perform routine inspections.Responsibilities
- Ensure daily, weekly, and monthly cleaning of the clean rooms
that include all classified areas using specified cleaning
chemicals and is compliant with cGMPs and safety regulations.
- Point person on shift to assign/distribute the work and
coordinate emergency situations.
- Lead investigations as related to GMP cleaning activities.
Author deviations, non-conformances, and CAPAs as required. Partner
with Quality to address these issues effectively and
- Ensure documentation (logbooks) are accurate and updated as
- Ensure that all Standard Operating Procedures (SOPs) are
followed and that all cleaning, disinfecting and documentation
expectations adhere to the Good Manufacturing Practices (GMP) and
Good Documentation practices (GDP).
- This role is responsible for the accurate, safe,
environmentally responsible, and quality compliant operations per
cGMP expectations and SOPs.
- Identify and implement opportunities to improve GMP
- Understand and be able to prepare chemicals properly and
understand the contact time for all chemicals.
- Read and understand all revisions of applicable assigned SOPs,
policies and procedures.
- Complete all training requirements for specific work areas and
Maintain all training requirements for staff.
- Interview and oversee contract employees.
- Communicate and resolve issues that present themselves.
- Exhibit safety leadership by example (e.g., utilize proper PPE
when performing job functions).
- Lead and mentor staff.
- Handle HR related matters and communicate those issues
effectively to the contractor.
- Work flexible hours including holidays, weekends, overtime and
special assignments. Qualifications
- Previous supervisory experience and demonstrated ability to
lead a team preferred.
- Minimum High School diploma or equivalent.
- A minimum of 3 years of experience in biopharmaceutical based
GMP manufacturing cleaning operations.
- Solid knowledge of FDA regulations and GMP systems.
- Excellent oral and written communication skills. Strong
technical writing ability preferred.
- Ability to don sterile protective equipment for entry into the
cleanrooms. Previous Aseptic cleaning experience.
- Must be able to lift over 35lbs and stand for extended periods
of time. The level of this position will be based on the final
candidate's qualifications. Please note this job description is not
designed to cover or contain a comprehensive listing of activities,
duties or responsibilities that are required of the employee for
this job. Duties, responsibilities and activities may change at any
time with or without notice. AveXis is committed to creating a
diverse environment and is proud to be an equal opportunity
employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, gender, gender
identity, national origin, genetics, disability, age, sexual
orientation or veteran status. #LI-GK1
Keywords: AveXis Inc., Durham , Supervisor, Manufacturing GMP Cleaning, Other , Durham, North Carolina
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