Lead Manufacturing Specialist
Job Opportunity at Spark Therapeutics, Inc

Posted on Nov 3

http://www.sparktx.com    215-220-9300

Location: Philadelphia, PA
Job Type: Full Time
Job ID: W4145855

This position is a key participant in the day-to-day manufacturing operations and planning of the vector production facility.  Reporting to the Manufacturing Lead, the primary responsibility of the Lead Manufacturing Specialist is to lead a suite team in the manufacturing of GMP grade vectors.  

S/he will participate in vector manufacturing, including support for clinical and commercial manufacturing, new product scale up, process optimization, technical transfer from process development to manufacturing, and process validation.  

RESPONSIBILITIES:

•    Hands-on manufacture cGMP manufacture including both upstream virus production and downstream purification

•    Prepares manufacturing support materials such as media and buffers

•    Prepares manufacturing equipment such as packing of chromatography columns

•    Performs and participates in investigations of process deviations by conducting data gathering, trending and data presentation as required

•    Writes and reviews manufacturing documents and procedures such as batch records and SOPs for virus production and purification

•    Maintains manufacturing equipment and records

•    Maintain safety procedures and compliance records

•    Contributes to manufacturing process monitoring for products transferring from research to manufacturing

•    Leads efforts for troubleshooting and solving production process/equipment problems

•    Organizes and manages detailed production schedules to ensure required tasks are performed

•    Ensures other manufacturing specialists comply with SOPs and that training is completed

•    Under the direction of Manufacturing Lead, leads the coordination and implementation of special projects such as validation or complex investigations

•    Advises Manufacturing Lead on improvements which may optimize work processes

•    Participates in internal meetings

QUALIFICATIONS:

•    Significant knowledge of cell culture or protein purification

•    Good written and verbal communication skills

•    Must be adaptable

•    Strict attention to detail

•    Work effectively in a team environment

•    Excellent organizational skills

•    Ability to lead daily operations for a small four to six member team

•    Ability to clearly and openly communicate with team

•    Guide and develop other employees

•    Requires thorough knowledge of Microsoft Office Suite

•    Able to make decisions whether results obtained during the manufacturing process comply with written procedures

•    Verifies process variations with more senior personnel

•    Consults with higher level personnel on unexpected or out of range results

•    Able to evaluate atypical events

•    High degree of initiative is required in resolving problems and developing recommendations

•    In collaboration with leadership, determines methods and procedures for completion of tasks

•    Continual interaction with members of his/her team as well as other manufacturing suite teams

•    Quality Control & Analytical Sciences

•    Quality Assurance

•    Facilities

•    Service personnel

•    Process Development

•    Materials Management

•    Must be able to lift 25 pounds

•    Must be flexible with work schedule and available to work extended shift 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 of time

•    Requires some contact with hazardous materials such as caustics.

REQUIREMENTS:

•    Bachelor's degree in biology, biomedical engineering, chemistry or chemical engineering required

•    7-10+ years of relevant experience in biopharmaceutical manufacturing facility subject to GMP regulations, or equivalent qualifications and experience.

•    Experience with cell culture or protein purification.

•    Demonstrated deep applied knowledge and understanding of cGMP regulations.

•    Strong knowledge of either upstream and/or downstream unit operations.

•    Demonstrated team leadership ability.

•    Strong organizational and planning skills.

WHO WE ARE:

Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.












SPRKManufacturing








Facebook TwitterLinkedIn
ChemicalEngineer.com is owned, operated, and copyrighted by Career Marketplace (© 2002-2018, All Rights Reserved)
CAREERMARKETPLACE INC BBB Business Review