Sr. Manufacturing Technician - Philadelphia, PA | Biospace
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Sr. Manufacturing Technician

Spark Therapeutics

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Location:
Philadelphia, PA
Posted Date:
11/15/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Biology, Biotechnology, Cell Culture, Genetics, Manufacturing, Protein Purification, Purification, Technician, Vaccine, Validation,

Job Description

This position is a key participant in the day-to-day operations and planning of the vector production facility, with a primary responsibility to execute established protocol of manufacturing clinical grade vectors in accordance with current Good Manufacturing Practices (cGMP). The position will participate in clinical grade Adeno-Associated Virus Vector (AAV) manufacturing, contribute to the implementation of documentation to support cGMP vector manufacture and participate in the production of cGMP gene transfer vectors to support clinical studies.
Hands-on cGMP manufacture in assisting upstream virus production and downstream purification
Prepare laboratory reagents/raw materials/column packing for the manufacture of clinical products
Participate in investigations
Review and revise SOPs and batch records for virus production and purification
Perform routine calculations and maintain appropriate records
Maintain manufacturing equipment and records
Maintain laboratory safety procedures and compliance records

RESPONSIBILITIES:

80% of the time
Hands-on cGMP manufacture in assisting upstream virus production and downstream purification
10% of the time
Prepare laboratory reagents/raw materials/column packing for the manufacture of clinical and non-clinical vectors
5% of the time
Review and revise SOPs and batch records for virus production and purification; maintain manufacturing and equipment records
5% of the time
Organize and graph manufacturing process data

Requirements

QUALIFICATIONS:

The position requires good knowledge and experience with cGMP upstream and downstream manufacturing of biopharmaceuticals or biologics.  
Experience with vector production and purification is preferred.  
Candidate should have the ability to work accurately, cooperatively with others and pay strict attention to detail.
Candidate must be adaptable and capable of working in various areas requiring intellectual and professional approaches.
Candidate should additionally have excellent organizational skills.
Good written and verbal communication skills and ability to work effectively in a team environment are required.
Requires thorough knowledge of Microsoft Office Suite.

REQUIREMENTS:

Bachelor's degree in biology, biomedical, chemistry, or engineering
6-10 years of relevant experience, or equivalent qualifications and experience
Experience with aseptic manufacturing of biopharmaceuticals (upstream and downstream)
Must have experience working in a cleanroom environment (ISO 8/7)
Must have experience in a regulated manufacturing environment using GMP