UPSTREAM MANUFACTURING ASSOCIATE III

Upstream Manufacturing Associate III Location: Pennington, New Jersey Category: Manufacturing Salary: Apply for details Country: United States Employment: Contract Worksite: On-Site Apply For This Position Job Description Pay range: 30-40/hr depending on experience Position Overview The Upstream Manufacturing Associate III (Lead) provides technical leadership and operational coordination for upstream manufacturing activities within a cGMP environment. This role is responsible for leading batch execution, troubleshooting complex process issues, coordinating cross-functional teams, supporting manufacturing readiness, and driving operational excellence initiatives. Key Responsibilities Manufacturing Leadership Lead daily upstream manufacturing operations and provide shop-floor technical support. Coordinate execution of production campaigns and manufacturing schedules. Ensure manufacturing readiness for batch execution. Serve as the primary technical resource during manufacturing operations. Upstream Processing Lead cell culture activities including vial thaw, seed train expansion, fed-batch and perfusion bioreactor operations. Oversee harvest and filtration operations. Monitor critical process parameters and implement corrective actions when required. Troubleshoot process and equipment issues to ensure uninterrupted operations. In-Process Testing Perform and review manufacturing support testing utilizing: Cedex Cell Analyzer Blood Gas Analyzer (BGA) Osmometer Other process monitoring equipment Documentation & Compliance Lead preparation and revision of: Standard Operating Procedures (SOPs) Master Batch Records (MBRs) Manufacturing forms and templates Support deviation investigations, CAPAs, and change controls. Ensure ongoing inspection readiness and GMP compliance. Participate directly in regulatory and client audits. Cross-Functional Coordination Coordinate activities between Manufacturing, QA, QC, MSAT, Warehouse, Facilities, and Supply Chain teams. Support process validation, technology transfer, and commercial manufacturing initiatives. Drive continuous improvement and operational excellence projects. Coaching & Development Train, mentor, and develop Associate I and Associate II personnel. Provide technical coaching and floor-based leadership. Support qualification and onboarding programs. Qualifications Education & Experience Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 5+ years of relevant biopharmaceutical manufacturing experience. Previous leadership, lead operator, or project coordination experience preferred. Required Skills Advanced expertise in mammalian cell culture and upstream operations. Extensive experience with fed-batch and perfusion bioreactor systems. Hands-on experience with Cedex, BGA, Osmometers, and related analytical equipment. Strong understanding of GMP regulations and manufacturing documentation systems. Proven leadership and decision-making abilities. Excellent troubleshooting and problem-solving skills. Preferred Skills Experience supporting: Technology transfers Process validation Commercial manufacturing Regulatory inspections Continuous improvement initiatives Physical Requirements Ability to stand for extended periods. Ability to bend, reach, and lift up to 50 pounds. Ability to work in cleanroom environments while wearing required PPE. Equal Opportunity Employer We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements. Fraud Alert Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.