Supervisor, Manufacturing GMP Cleaning

Location
Durham, NC, US
Posted
Aug 27, 2020
Ref
5413
Hotbed
Bio NC
Required Education
High School or equivalent
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

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 compliantly.
  • Ensure documentation (logbooks) are accurate and updated as required.
  • 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 cleanings.
  • 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.

Novartis Gene Therapies 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.

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