Process Sciences Engineer

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.

The Process Sciences Engineer will be primarily responsible for support of technology transfer (TT) & manufacturing support activities for both upstream and downstream aspects of Drug Substance (DS) Manufacture.  The Process Sciences Engineer will also be responsible for supporting the development and implementation of standard processes and procedures for work performed within MS&T.

RESPONSIBILITIES

Execute on Technology Transfer (TT) deliverables for Spark’s clinical and commercial assets ensuring delivery on MS&T objectives.

• Generate and review documents for TT and validation including Facility Fit Assessments, Risk Assessments, Manufacturing Batch Records, Process Validation Protocols and Reports, Process Control Strategy, and any process related compliance documents.
• Generate and review process related SOPs and policies.
• Generate and review manufacturing investigations and root cause assessments, deviations, and change controls required to disposition batches and maintain lifecycle of Spark assets.
• Execute Root Cause Analysis and Risk Assessment Programs and address gap assessments in preparation for GMP Manufacturing.
• As needed, be present at CMOs & CDMOs to monitor execution of production and studies, as well provide technical guidance as needed. 
• The candidate may lead TT Sub Team meetings with guidance from Process Sciences Management.
• Support authoring and preparation of content for regulatory documents, interactions, and inspections.
• Support initiatives to streamline MS&T processes.

Manage individual performance and cross functional team to achieve business goals and objectives, as well ongoing professional development.

• Manage performance: Take responsibility, drive results, and achieve expected outcomes. Know what is expected of them, what it takes to be successful, and how they are progressing.    Hold everyone accountable to achieve results while demonstrating the Spark Values. Help cross functional team members understand how their work contributes to the overall success of Spark.
• Commit to collaborate:   Be a strong team player and business partner cross-functionally. Understand the development goals, strengths and motivators of your colleagues and partner to achieve mutual success and continuous improvement as well as professional development.
• Foster Spark’s Culture, Mission, Vision, and Values:  Lead by example.  Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.

REQUIREMENTS

• BS in Life Science/Engineering or related field required.
• Minimum 2 years of experience in the Biotechnology or Pharmaceutical industry.
• Experience in biopharmaceutical based GMP manufacturing science and technology including direct experience in cell culture, recovery and purification in development and/or production environments.  Experience in technology transfer or process engineering preferred.
• Demonstrated technical project management experience to develop project goals, deliverables, and timelines.
• Knowledge of GXP compliance.
• Up to 30% travel.

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 $74,900 to $112,300.

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.