SOKOL GxP Services

Support raw materials management, vendor interactions, and process improvements in biomanufacturing. | Bachelor's or Master's in Biochemical, Chemical, or Biomedical Engineering or related field; experience with raw materials, GMP, data management, and cross-functional teamwork. | We are looking for a Associate Engineer to join the raw materials team within the CTTO (Cell Therapy Technical Operations) department. The Raw Materials team is responsible for management of end-to-end raw materials including buffers, reagents, media, single-use system and lentiviral vector. This includes but is not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation management, process improvements to support CAR-T therapies during late stage clinical, tech transfer, and commercial production. Responsibilities include, but are not limited to, the following: Support as a SME for raw materials including single-use systems (SUS) and material sciences. Provide technical support on in CAR-T commercial manufacturing. Lead projects involving the introduction and qualification of materials, second sourcing efforts, and development of material specifications. Collaborate cross-functionally to execute risk mitigations and initiatives to improve the quality and supply chain robustness of existing raw materials. Deliver strategies for prioritizing and executing raw material projects, including the establishment and improvement of internal standards and business processes. Vendor management including change controls, audits, deviations, and QRM programs. Support investigations and ensure compliance with internal standards and requirements. Perform technical diligence visits to raw material supplier sites with cross-functional teams. Provide necessary technical analysis to support impact assessments and investigations. Support responses for Information Request (IR) from regulatory bodies. B.S. or M.S. in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent. Exposure to raw materials (both liquid and single use system). Understanding of regulatory/compendial requirements for raw materials used in biomanufacturing. Experience working with vendors and contract manufacturing sites. Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. Data management skills and comprehension skills of technical documents, such as process description documents. Ability to assess risk and develop contingency plans for process risks. Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities. Detail oriented with excellent verbal and written communication skills. Strong interpersonal and leadership skills to work with teams in different functions and organizations. Experience with Quality Management System (Ex. Deviation, CAPA, Change Management). Knowledge of GMP manufacturing practices and documentation requirements. Prerequisites: Experience in Single Use Systems, GMP experience, Data Management. Additional Skills: Understanding of key considerations for single-use containers used for raw materials. Familiarity with raw material supply chains and manufacturing methods. Data management and grasp apprehension of technical instructions. Lean Manufacturing experience is desired. Competitive hourly rate: $28.78 – $35.11/hr (W-2 only, no C2C) Working Hours: Monday - Friday, regular business hours 6-month contract with possible extension Health insurance, holiday pay, 401(k) program, and other benefits Employee referral bonus program

Lead and manage supply chain projects including planning, execution, risk management, stakeholder communication, and continuous improvement in a hybrid work environment. | 5-7 years of supply chain project management experience, strong project management skills, proficiency in supply chain software and analytics tools, and ability to work hybrid onsite. | SOKOL GxP Services is looking for a Senior Project Manager - Supply Chain to join our client's team in New Brunswick, NJ. This hybrid role will be pivotal in managing and optimizing the supply chain processes to ensure the efficient delivery of products and services. As a Senior Project Manager, you will lead cross-functional projects, coordinate between various internal teams and external partners, and drive initiatives that enhance supply chain efficiency while ensuring compliance with industry standards. Key responsibilities include: • Oversee the planning, execution, monitoring, and closure of supply chain projects. • Develop project timelines, budgets, and resource planning while managing risk and scope changes. • Facilitate communication between stakeholders to ensure project alignment with business objectives. • Implement best practices in supply chain management and project management methodologies. • Conduct regular status meetings to report on project progress and address any issues or challenges. • Lead continuous improvement initiatives to optimize performance across the supply chain. • Oversee and lead new product launches from North American CMOs; develop and maintain launch-related metrics and dashboards to ensure visibility and drive action. • Partner with the Launch Excellence team to ensure alignment of product flows, master data, and forecasts. • Support ExM Virtual Plant Teams with tech transfer projects, ensuring supplier capability to meet all requirements. Bachelor’s degree in Supply Chain Management, Business Administration, or related field. A Master’s degree is a plus. Minimum of 5–7 years of experience in project management within the supply chain sector. Proven track record of successfully managing complex supply chain projects and cross-functional teams. Strong understanding of project management methodologies (PMP certification preferred). Excellent analytical, problem-solving, and decision-making skills. Strong communication and interpersonal skills, with the ability to influence and collaborate effectively. Familiarity with supply chain software and tools for project management, forecasting, and analytics. Proficiency in Excel, PowerPoint, Tableau, Spotfire, and SAP. Ability to work effectively both independently and in a team environment in a hybrid model. Competitive hourly rate: $70 – $80/hr (W-2 only, no C2C) Hybrid schedule (50% onsite Tu – Thu; full onsite during the first month) 12-month contract with possible extension Health benefits, holiday pay, and 401(k) program Paid time off (PTO) and professional development support Employee referral bonus program Opportunity to contribute to high-impact projects with a leading biopharma company