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GMP Technician - Documentation Specilaist

Employer
Andelyn Biosciences
Location
Columbus, OH
Start date
Nov 22, 2022

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Discipline
Regulatory, Research/Documentation
Required Education
High School or equivalent
Position Type
Full time
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Job Details

It’s an exciting time to join us!

The Andelyn Biosciences’ Manufacturing group is seeking a motivated individual to join our growing team as a Technician - Documentation.

The Technician role will be responsible for learning aspects of the adeno associated viral (AAV) vector production.  As an entry level position, the Technician will be trained in the skills and responsibilities of the position.  They will continue to develop the skills of the production of AAV viral vectors. A successful candidate will be responsible for staying up to date with training and developing their skill set to support the GMP production scheme.   The focus of good documentation practices will require the candidate to maintain highly organized documentation.  They will be responsible for drafting documents used in GMP manufacturing, review executed documents and work closely with Quality, Business groups and clients.

 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                  575 Children's Crossroads

                  Columbus, OH 43205 

 

Under the guidance and direction of the Operations Supervisor, essential functions of the Technician include at a minimum:

  • Learn all areas of operation involved in Production, Purification, and Cell Culture schemes.
  • Responsible for learning and assisting operations in the support of the manufacture of viral vectors used in clinical trials.
  • Operate within the Quality Management System applicable to the manufacture of phase appropriate material in a clean room environment.
  • Adhere to good documentation principles and ALCOA in the support of all production activities.
  • Perform review and corrections under the guidance of ALCOA+ and GdocP practices.
  • Supports daily documentation operational activities related to the GMP manufacturing of biological products.
  • Perform data analysis on critical process parameters in batch records and other GdocP documents.
  • Uphold a clean and safe work environment, including stocking, cleaning, and maintaining cleanroom production environment.
  • Provide training to staff.
  • Anticipate, solve, correct, and prevent problems including error trending and CAPA implementation.
  • Draft and revise SOPs and other process documents.
  • Maintain compliance with applicable regulatory requirements for gene therapy products.
  • Perform tasks as assigned by leadership to support meeting organization’s goals.
  • Ability to work with some independence based on applicable experience.
  • Involvement in audits, customer relations, and responsibility for inspection outcomes.
  • Has fiscal responsibility for areas of oversight.
  • Support a cohesive, high- performing team.
  • Limited involvement in customer relations.

 

Knowledge, Skills and Abilities required:

  • High School diploma or equivalent minimum.
  • No minimum experience
  • Experience in the manufacture of biologics or gene therapy required with understanding of AAV vector science is helpful but not essential.
  • Ability to work with highly confidential materials.
  • Work in a diverse and collaborative team environment utilizing clear communication to deliver high productivity.
  • Familiarity with biochemical procedures used in biological manufacturing beneficial.
  • Familiarity in USP, 21 CFR 211 and ISO are beneficial.
  • Experience in performing in highly skilled teams is preferred.
  • Maintains positive work environment.
  • Able to gown and wear clean room PPE for extended periods of time.
  • Fine motor skills.
  • Able to lift weights of 45 lbs. or more repeatedly.
  • Must have legible handwriting.

 

Minimum Physical Requirements

  • Sitting for extended periods Constantly (33-100%)
  • Talking on the phone/in person Constantly (0-33%)
  • Typing on a computer keyboard Constantly (33-100%)
  • Standing/walking Occasionally (67-100%)
  • Lift weight at 45lbs or greater repeatedly (33-67%)
  • Ability to wear cleanroom PPE (33-67%)
  • Time spent in cleanroom environment (0-33%)
  • Fine motor skills (33-67%)

 

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.    

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

 

Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.

 

 

Company

Andelyn Biosciences is a biopharmaceutical CDMO Pioneering Solutions That Turn Hope into Reality™. With 20+ years of experience manufacturing viral vectors, Andelyn's scientific expertise for development and characterization has led to GMP material being produced for over 75+ worldwide clinical trials and 400+ cGMP clinical batches. Advanced quality systems, full regulatory support, and supply chain vertical integration help accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. The name "Andelyn" is a hybrid of two gene therapy pioneers who participated in pivotal Phase I clinical trials at Nationwide Children's Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. "Andelyn" combines their names, representing all the families who have courageously participated in the research that make today's gene therapies possible. Continuing Andelyn's patient-based mission, the company is opening two state-of-the-art commercial manufacturing and development sites. The Dublin-based Andelyn Development Center is set to open in May 2022 and will house Andelyn's preclinical and development services. The 185,000 square foot Andelyn Corporate Center located on The Ohio State University's Innovation District will open for production in mid-2022.  

Find Us
Website
Phone
614-580-8522
Location
515 E. Main St
Columbus
OH
43215
United States
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