Senior Specialist, Engineering

Job Description

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough.

Seeking candidates for a Senior Specialist position within our company's research laboratories Biologics Pilot Plant (BPP) Operations Team. This person will work on pilot-scale campaigns for the Good Manufacturing Practice (GMP) manufacture of bulk clinical supplies, leading operations on either upstream or downstream steps, and contributing to manufacturing activities in the other disciplines as needed. Strong comprehension of regulatory guidelines governing GMP manufacture is essential. The candidate will work in matrixed teams in close partnership with analytical and process development groups, facility engineering, quality engineering, GMP compliance, and safety groups. Some overtime, including weekends and occasional second and third shift work, will be required. Assignments include all aspects of preparation, execution, and closeout of a GMP campaign.

Primary Responsibilities:

• Executing upstream unit operations such as mammalian/yeast/bacterial cell expansion, virus/protein expression in single-use disposable systems and/or stainless-steel bioreactors.

• Performing downstream operations such as normal flow filtration, tangential flow filtration, homogenization, lyophilization, chromatography, and centrifugation.

• Preparing critical documents (e.g., Standard Operating Procedures, batch records).

• Completing such activities as equipment cleaning & steam sanitization.

• Evaluating and integrating innovative technology/process equipment fit.

• Developing equipment specifications & participating in start-up activities.

• Working in a multi-disciplinary project team environment.

• Troubleshooting process unit operations.

• Leading teams. This person will eventually lead projects/programs and must be able to objectively resolve problems and issues.

Education Minimum Requirements:

• Bachelor’s degree in chemical engineering or Biological Sciences with minimum 5 years of relevant experience or a master’s degree with minimum 3 years of relevant experience.

Required Experience and Skills:

• GMP manufacturing of biologics, or vaccines, and/or process development activities.

• Strong teamwork and collaboration

• Extensive knowledge of cGMP, Quality Systems, and safety for operations

• Highly self-motivated with the ability to work in a fast-paced and dynamic setting

Preferred Experience and Skills:

• Excellent organizational, problem-solving, and project management skills

• Strong technical background in several process unit operations

• Experience leading teams in a matrixed organization

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, vi