Manufacturing Specialist

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. 

We don’t follow footsteps. We create the path.

Manufacturing Specialist 

Primary Duties

This position is a key participant in the day-to-day operations of the viral vector production facility, with a primary responsibility to execute established procedures of manufacturing commercial and clinical grade gene transfer vectors in accordance with current Good Manufacturing Practices (cGMP). The position will participate in commercial grade Adeno-Associated Viral Vector (AAV) drug substance manufacturing for approved markets, participate in the production of clinical AAV drug substance to support process development/characterization/validation studies and clinical trials, and contribute to the implementation of documentation to support cGMP vector manufacture.

• Hands-on cGMP manufacture for upstream (cell culture) viral vector production and downstream purification.
• Sampling and weigh/dispense of raw materials, preparation of Manufacturing media/solutions/buffers, and column packing to support manufacture of commercial, clinical, and non-clinical vectors.
• Participate in aseptic fill operations of viral and excipient products.
• Participate in deviation investigations and corrective/preventive actions.
• Review and revise SOPs, Forms, and batch records for viral vector production and purification.
• Maintain manufacturing equipment and associated records, such as installation forms and electronic logbooks.
• Maintain laboratory safety procedures and compliance records.

Responsibilities

• Hands-on cGMP manufacturing including both upstream virus protection and downstream purification.
• Prepares manufacturing equipment such as packing of chromatography columns.
• Participates in investigations of process deviations by conducting data gathering, trending and data presentation, as required, performing root cause analyses and impact assessments.
• Writes and reviews manufacturing documents and procedures such as batch records and SOPs.
• Assists with process and equipment training for newer personnel, as needed.
• Contributes to manufacturing process monitoring for products transferring from process development to manufacturing.
• Participates in efforts for troubleshooting and solving production process/equipment problems.
• Under the direction of Manufacturing Functional management, participates in the coordination and implementation of special projects such as validation or complex investigations.
• Advises Manufacturing Leads on improvements which may optimize work processes.

Education and Experience Requirements

• Bachelor's degree in biology, biomedical, chemistry, or engineering.
• Generally, has 2+ years of relevant experience, or equivalent qualifications and experience.
• Experience with aseptic large scale cell culture or protein/biologics purification.
• Must have experience working in a cleanroom environment (ISO 8/7).
• Demonstrated knowledge and understanding of cGMP regulations.
• Cell culture or protein purification experience

Other Job Requirements

• Must be able to lift 25 pounds.
• Must be flexible with work schedule and available to work extended shift and weekend hours, as determined by management.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment.
• Must be able to stand for long periods.

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.  The base salary range for this position is currently from $54,000 to $81,000. 

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.