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

Job Description

The Pharmaceutical Analytical Sciences group has an opening for a second shift Specialist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

In your role as Specialist, you will be part of a team in charge of managing, coordinating, and facilitating analytical support for the Rahway manufacturing facilities for drug substance, drug product dosage forms and potent compounds. This role is fully onsite during 2nd shift operations (3pm-11:30pm).

• Coordinate and analyze real-time analytical support for critical manufacturing samples during second shift (3 PM to 11 PM) operations.
• Support the execution of Good Manufacturing Practices (GMP) activities such as release of raw materials, solvents, excipients for use in the Rahway manufacturing areas.
• Provide analytical support to our pilot plants for cleanout 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.
• Contributes expertise and creativity to collective knowledge and aids in solving complex problems.
• Directly contributes to experimental design, execution and data interpretation for GMP project support.
• Strong collaboration 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, ensure samples are properly disposed of.

• Minimum 3 years relevant industry experience for applicants with a Bachelor of Science degree, or
• 1 year of relevant industry experience for applicants with a Master of Science degree
• 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 are 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 are also a plus.

$96,200.00 - $

We offer a comprehensive package of benefits including medical, dental, vision, healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and 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.

US and Puerto Rico Residents Only.

Shift: 2nd - Evening
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Valid Driving License:
No
Hazardous Material(s): N/A
Job Posting End Date: 06/24/2026
Requisition : R395505