Assistant Scientist/Process Engineer

Primary Responsibilities:

• The Process Engineer will play a key role in ensuring successful manufacture of life-saving cell therapy products.

• The primary focus of the Process Engineer will be to support testing and implementation of operational improvements and resolve manufacturing process investigations at the cell therapy GMP manufacturing facility.

• The engineer will be part of a team tasked with determining the root cause of manufacturing investigations.

• This individual will design and execute experiments, evaluate data, and draft technical reports in support of improvement, investigations, and manufacturing process changes.

• The Process Engineer will also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes.

• Design and execute experiments in the process development labs which includes aseptic processing and operation of automated process equipment.

• Summarize experimental data and aid in analysis to draw conclusions.

• Coordinate with the analytical group for timely delivery of process samples and turn-around of analytical data.

• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.

• Develop and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements.

• Support process comparability and process validation studies including planning, execution, and documentation management.

• Support necessary technical experiments and analysis to enable decisions related to raw materials changes.

• Flexibility with work schedule as maintenance of cell cultures on occasional weekends, early mornings, or evenings is required

Required Qualifications:

• Degree in Biological Sciences, Chemical Engineering, Life Sciences or related discipline.

• BS degree with minimum of 2+ years of relevant experience, or MS degree with minimum 0+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.

• Excellent documentation skills and attention to detail

• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.

• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.

• Excellent problem-solving skills.

• Able to creatively manage time and elevate relevant issues to project lead and line management.

• Strong scientific and technical writing with excellent oral communication skills.

• Aseptic processing skills

Preferred Qualifications:

• Experience with cell therapy process development or manufacturing

• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)

• Experience executing investigations in support of commercial manufacturing

• Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability

• Combination of experience in process development, MSAT and quality.

• Operational excellence training/background

• Experience working cross-functionally with GMP experience preferred

• Hands on cell culture experience preferred

• Position Handles Hazardous Materials

• cGMP experience a plus.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.