Specialist, Research; 2nd Shift Specialist: In-Process Controls

Primary Responsibilities

As a Specialist you will manage, coordinate, and facilitate analytical support for the Rahway manufacturing facilities for drug substance, drug product dosage forms, and potent compounds during the second shift (3pm–11:30pm). Your main responsibilities include:

• Coordinate and analyze real‑time analytical support for critical manufacturing samples during second shift operations.
• Support the execution of Good Manufacturing Practices (GMP) activities such as release of raw materials, solvents, and excipients for use in the Rahway manufacturing areas.
• Provide analytical support to our pilot plants for clean‑out samples pre‑batch and post‑batch.
• Transfer analytical methods to support manufacturing scale‑up batches under GMP settings.
• Perform data entry, data review/approval, and author analytical reports or data summaries.
• Troubleshoot and lead any investigations associated with GMP testing through active collaboration with cross‑functional project teams and/or Quality stakeholders.
• Identify appropriate corrective and preventative actions.
• Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA principles.
• Contribute expertise and creativity to collective knowledge and aid in solving complex problems.
• Directly contribute to experimental design, execution, and data interpretation for GMP project support.
• Collaborate closely with internal stakeholders and partners such as Chemical Engineering, Process Chemistry, Pharmaceutical Operations, and Quality Assurance.
• Support internal and external compliance audit activities.
• Manage incoming and outgoing flow of samples, ensuring samples are properly disposed of.

• Minimum 3years of relevant industry experience for applicants with a Bachelor of Science degree, or 1year of relevant industry experience for applicants with a Master of Science degree in Chemistry, Pharmaceutical Sciences, or other Life Sciences.

• A proven record of executing a myriad of analytical techniques, methodologies, instrumentation, and strong technical problem‑solving.
• Excellent written and oral communication skills.
• Interpersonal skills necessary to qualify for this role.

• Hands‑on experience in GMP Operations.
• Real‑time analytical support for a manufacturing facility.
• Experience with LIMS, Empower, and SAP is also a plus.

• Analytical Instrumentation
• Audit Support
• Data Analysis
• Experimentation
• GMP Compliance
• Manufacturing
• Standard Operating Procedure (SOP) Writing
• Troubleshooting

We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants for employment. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under U.S. Equal Opportunity Employment laws, visit EEOC resources.

Salary range: $96,200.00 – $. Eligible for annual bonus and long‑term incentive, if applicable.

Benefits include medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, compassionate and sick days.