Specialist, Research (2nd Shift Specialist: In-Process Controls)
About The Position
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).
Requirements
- 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 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.
- Analytical Instrumentation
- Audit Support
- Data Analysis
- Experimentation
- GMP Compliance
- Manufacturing
- Standard Operating Procedure (SOP) Writing
- Troubleshooting
Nice To Haves
- Hands-on experience in GMP Operations.
- Real-time analytical support for a manufacturing facility.
- Experience with LIMS, Empower, and SAP are also a plus.
Responsibilities
- 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.
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
