Job Description:

Position Title: Process Engineer - API Lab System Lead

City: Linden

State: NJ

Department: Unassigned Department

Description:

The Spear Group Full-Time Opportunity w/ Benefits

Position: Process Engineer – Lab System Lead for API Analytical Lab Packages

Location: Linden, NJ

Position Summary:
The Spear Group has an exciting Process Engineer opportunity to participate in supporting efforts for process operations by managing multiple analytical lab packages related to API drug substance processing. The ideal candidate will be a chemical engineer or bioprocessing engineer or have a related biopharmaceutical engineering degree. This is an opportunity to be part of an innovative bioprocessing team with our global biopharma client at their site in NJ. Seeking a highly motivated process engineer to work in a fast-paced role that requires a high degree of technical and project team collaboration responsibility. This role will primarily be responsible for the lab systems and analytical API lab packages (batch testing for compound specifications).

Key Responsibilities:

• System Lead for the analytical lab within the API suite for compound batch testing/analysis.
• This process engineer role will serve as a process development team member supporting the drug substance analytical stage by managing all related lab systems/packages (API compound batch testing).
• This position will attend and help lead regular API lab system management meetings to support process development efforts and analytical API drug substance lab testing.
• Assist in preparing for sample prep skid FAT.
• Provide ergonomic assessment for the analytical lab.
  The selected candidate is expected to be a key part of a team of process/facility engineers and foster a culture of collaboration, learning and innovation specifically supporting small molecule drug substance analytical lab processes.
• Assist in the analytical lab area processes/systems related to the development of manufacturing related GMP steps.
• Be an integral part of the lab system applied to create lab packages used to generate API test data which contributes to process definition and provides clinical material when needed.

Required & Desired Experience and Education:

• Bachelor’s degree in chemical engineering or related scientific engineering field with minimum of 2 years relevant experience, or a master’s degree with 1 year of relevant experience. Experience working in a GMP clinical or manufacturing supply facility.
• Experience with GMP start-up and/or qualification processes is a plus.
• Experience with small molecule drug substance and/or biologics process development.
• Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.
• Effective interpersonal and communication skills, both verbal and written.
• Excellent organizational skills to multi-task.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.
• Experience with lab activities for compound testing processes is a plus.

Compensation based of relevant experience

EQUAL OPPORTUNITY EMPLOYER

The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.

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