About Probio

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

Job Scope:

A leading biologics and CGT CDMO company in rapid expansion seeks a Senior Procurement Manager. The role focuses on designing strategies for optimal cost control, enhancing vendor management, achieving significant cost savings, and improving procurement sourcing and efficiency. Responsibilities include delivering insights to the executive team, standardizing business methodologies, evaluating procurement processes, and identifying improvement areas.

Responsibilities:

1. Take full responsibility for the end-to-end procurement management of different categories, include but not limit to material, services, equipment, engineering and etc.
2. Align the Purchasing team's goals with organizational objectives, address complex issues by focusing on the needs of internal and external stakeholders to enhance sourcing and procurement processes, in line with global initiatives.
3. Develop, evaluate and maintain qualified supplier resources, and establish long-term partnerships with key suppliers, conduct regular supplier audit and performance evaluations.
4. Negotiate and manage purchasing contracts to improve key terms including price, payment terms, delivery lead time, quality standards and after-sales service, ensure quality and mitigate risks.
5. Coordinate and resolve the issues during the procurement process, including delivery delays, unqualified quality, return and replacement of the goods, to ensure the continuity of the company’s production.
6. Responsible for implementation of purchasing control policy, development of working instructions and guidelines for users on how to deploy it, continuously drive process improvement.
7. Responsible for team building, staff training, develop KPIs and performance evaluations.
8. Manage the daily work of procurement team, formulate teamwork plans and objectives, guide subordinates in supplier development, price inquiry and comparison, contract signing and other work, and improve the overall professional procurement capabilities of the team.
9. Strictly comply with relevant pharmaceutical regulations (cGMP, FDA) and the company’s internal procurement system to ensure the compliance of procurement processes and prevent procurement risk.

Qualifications:

1. Bachelor's degree or above in Business, Supply Chain Management, Engineering, or related field.
2. At least 10 years of procurement experience in biotech/pharmaceutical/CDMO, with expertise in cGMP procurement and regulatory compliance ((FDA/EMA, ICH Q7). 
3. Proven ability to negotiate with vendors for favorable terms and cost reductions.
4. Proficiency in supply chain planning, forecasting demand, and managing inventory lead time to meet business needs.
5. Data-driven decision maker with exceptional leadership and communication skills, capable of setting clear visions and strategies.
6. Experience in leading multi-cultural teams, valuing diversity, and navigating global business dynamics.
7. Excellent technical skills, proficient in Excel, Word, PowerPoint, Project and SAP/S2P(Ariba or GEP) systems.
8. Expertise in strategic sourcing, evaluating and qualifying suppliers to optimize cost, quality, and supply reliability is preferred
9. CPSM (Certified Professional in Supply Management) or Six Sigma Green Belt is preferred

The salary range for the role is 120k - 160k depending on experience and skill set

#PB

#LW

About ProBio:

 ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017

Job Scope

The Senior Manager, Quality Operations is responsible for Manufacturing & QC Shop-Floor Quality, Batch Release, Document Control, and Training functions. He /She oversees the group responsible for quality functions related to Good Manufacturing Practices (GMP) and Phase-Appropriate compliance for both clinical and marketed Gene Therapy products and Plasmid DNA at the Hopewell manufacturing facility. He /She is expected to grow and develop the group commensurate with the business need.

Essential Responsibilities:

Lead Probio Quality Operations and Batch Release Program for Gene Therapy and Plasmid Manufacturing. This may include, but may not be limited to the following functions:

• Develops procedures for and performs local batch disposition for Gene Therapy Drug Substance, Drug Product, MCB (Master Cell Bank), Plasmid and Finished goods manufactured at the Hopewell, NJ site.
• Issues batch compliance documentation such as Certificates of Conformance/ Compliance / Quality (CoCs/COQs), Certificates of Analysis (CoAs), BSE/TSE Statements.
• Develops and manages QA functions related to Cell Bank and Plasmid disposition, usage, and lifecycle.
• Oversees ProBio QA Area Release/ Line Clearance Procedures and facility walkthroughs.
• Oversees the QA approval of calibration reports for GMP equipment/instruments in Maximo
• Supports internal and external audits to assure compliance with GMP regulations.
• Manages or performs QA “person-in-plant” type activities during cell bank receipt, manufacturing, filling, labeling, visual inspection, packaging, warehousing and shipping activities.

Directs Document Control, Records Management & training activities for the Gene Therapy Manufacturing Site Activities. This may include, but may not be limited to the following functions:

• Oversees Document control activities related to approval of local electronic documents such as SOPs, Standards, Forms, Work Instructions, Master Batch Records, and specifications.
• Develops and implements local procedures for control of drug product label proofs, printed labels, and reconciliation of unused/damaged labels.
• Manage Veeva Vault administration for all Veeva Vault applications.
• Supports interactions with regulatory authorities related to manufacturing quality and compliance policies, guidelines, and systems.
• Recommends Quality system changes to enhance overall job performance and Quality functions and partners with peers in overseeing the implementation of these changes.

Qualifications:

• Bachelor’s degree in a scientific discipline and a minimum 7 years of experience in Quality or related role(s) in a pharmaceutical, biotechnology or related environment, and at least 3 of which have been in a CMC-focused Quality position.
• Experience with Veeva Vault Quality Docs and Training
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Demonstrated knowledge of biologics, viral vector, and plasmid manufacturing and testing.        

The Pay range is estimated between $110000 - $150000, based on experience and skill set

# LW

# PB

About ProBio:

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

Job Scope:

This position is responsible for coordinating and overseeing facility outside services, engineering and construction capital projects for GXP & non-GMP facilities in New Jersey. This role will focus on working with external engineering design firms, construction contractors, landlords, and government offices, as well as all internal departments.

Essential responsibilities:

• Manage multiple facility outside services, engineering and construction projects ranging from $0.05MM to $30MM at any given time.
• Direct day-to-day activities of project team to achieve the following for each project:
• Log and track action items through project lifecycle.
• Bid, award, and select engineering firms, construction firms, equipment vendors, CQV consultants, and service contractors.
• Ensure that user requirement specifications are appropriately met through high quality project deliverables.
• Develop and maintain a project schedule to foster accountability and note staffing requirements.
• Manage project capital budget, ensuring on-time and under-budget project completion. Ensure that POs and contracts are issued within budget and company standards.
• Review and process change orders in accordance with contract requirements.
• Prepare project updates and budget release presentations to be provided to upper management teams.
• Build partnering relationships with project executives, landlords, contractors, and consultants.
• Host Gemba Walks and track observations correction to fulfill continuous site improvement.
• Execute and manage site-wide controlled drawings program. Complete physical verification, redline, correction, and control of drawings required for qualification activities.
• Establish and maintain site security program. Assign new badges, control security clearances, and rectify security incidents.

Qualifications

• Bachelor’s or advanced degree in Construction Management, Mechanical Engineering, Biomedical Engineering, or other Engineering capacity.
• Strength in managing facility & construction projects for facilities in the pharmaceutical industry.
• Experience in project management and engineering practices. PMP or similar project management certification is preferred.
• Familiarity with estimating and bidding
• Experience in negotiating with landlord, government regulation offices, and engineering/construction contractors.
• Understanding of manufacturing processes for plasmid DNA and viral vectors in the cell & gene therapy industry.
• Possess strong written and communication skills.
• Proficient in Auto Cad & Microsoft Project highly desired.

The estimated pay range for the role is between $100000 - $120000 depending on experience and skill set

# LW

# PB

About ProBio:

ProBio, a subsidiary of GenScript, has a one stop biopharmaceutical R&D and production platform, mainly dedicated to cell and gene therapy (CGT) drugs, vaccine and biopharmaceutical discovery, antibody protein Provides end-to-end CDMO services from target development to commercial production. GenScript has established companies in the United States, the Netherlands, South Korea, Shanghai, Hong Kong, Nanjing and other places to serve global customers. Since October 2017, it has assisted customers in the United States, Europe, Asia Pacific and other regions to obtain more than 50 IND approvals.

The Expert of QA Technical Operations will be responsible for:

• Interpreting, building upon, and complying with company quality assurance standards
• Managing daily supplier quality activities and controls
• Supporting the Strategic Supplier Management process to meet quality, delivery, and cost objectives
• Developing and executing strategic plans to improve supplier quality, delivery, and costs
• Overseeing inbound material release process
• Champion quality assurance procedures, tools, and techniques

Roles and Responsibilities

• Author/Review SOPs
• Oversee the GMP supplier qualification program and supplier risk management
• Completes the approval requirements to qualify new suppliers including negotiating quality agreements, as well as audit scheduling, conduction of audits, and authoring of audit reports
• Periodic review of suppliers and identification of supplier compliance issues
• Manages vendor complaints
• Participates in or manages quality assessments of internal operations and suppliers to analyze compliance and assess risk
• Liaison between Supplier and QA representatives in addressing the quality concerns from the supply chain
• Monitor supplier non-conformance performance, and drive root-cause analyses, corrective actions & process improvements to reduce the Number of Defects & Cost of Quality
• Ensures effective and timely investigation and closure of all CAPAs, supplier non conformances, complaints, and product issues
• Development and maintenance of measurement systems for quality costs, indicators, trends and supplier rating
• Collects data and compiling supplier scorecards
• Manages audit schedule and executes supplier audits
• Generates specifications for materials and consumables
• Responsible for disposition of materials and consumables
• Approve calibration reports for GMP equipment
• Support QA Validation in review of SOPs
• May interface with auditors during regulatory inspections
• Works closely with Facilities, QA Validation, Manufacturing, and QC teams
• Travel expectations: < 10%

Qualification

• Bachelor's degree in science, Engineering, Business, Management or related field (Advance degree a plus)
• 3-5+ years of experience in Quality, Manufacturing, Engineering, or related field
• Results oriented, driven individual
• Excellent interpersonal, communication and negotiation skills
• Strong organizational and problem-solving abilities
• High attention to detail and accuracy
• Ability to work collaboratively in a team environment

The estimated pay range for the role is between $70,000 - $95,000 based on qualifications and experience.

#LW

#PB

About ProBio:

ProBio, a subsidiary of GenScript, has a one stop biopharmaceutical R&D and production platform, mainly dedicated to cell and gene therapy (CGT) drugs, vaccine and biopharmaceutical discovery, antibody protein Provides end-to-end CDMO services from target development to commercial production. GenScript has established companies in the United States, the Netherlands, South Korea, Shanghai, Hong Kong, Nanjing and other places to serve global customers. Since October 2017, it has assisted customers in the United States, Europe, Asia Pacific and other regions to obtain more than 50 IND approvals.

Job Scope:

The Automation Engineer is responsible for administration and management of the site’s automation systems, including Supervisory Control and Data Acquisition (SCADA) system, PLCs, notification systems and computerized QC Lab instruments. The scope of the responsibilities includes the initial installation, ongoing maintenance, periodic back-up, change control, validation, and retirement of systems.

The incumbent works cross-functionally with internal departments including Information Technology, Manufacturing, Facilities & Engineering, Quality Control, and Quality Assurance, as well as external resources/vendors to maintain the site’s automation systems. The incumbent supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities:

•    Work closely with stakeholders to understand and fulfill system requirements and improve the quality of automated processes.
•    Collaborate with stakeholders, including Area Managers, System Owners, and System Users to ensure successful onboarding, use and retirement of automation systems.
•    Develop appropriate Validation Protocols, Reports, and Lifecycle documents.
•    Execute Validation Protocols and collecting test evidence. 
•    Create and improve Administration SOPs of automation systems
•    Monitor integrity, availability, performance and operability of automation systems.
•    Identify, investigate and correct technical issues, including performing root cause analysis for production errors.
•    Make adjustments, enhancements and applying patches or upgrades as required for automation systems, while adhering to the Change Control process.
•    Understand network operations, system operations, and Cloud-based systems.
•    Administer user access management.
•    Ensure compliance with applicable regulatory standards.
•    Maintain up-to-date knowledge of current technology trends, programming languages, and automation best practices for bioprocess equipment including single-use bioreactors, chromatography controllers, ultrafiltration skids, and QC instruments.
•    Author appropriate Change Controls and Test Scripts and serve as the Subject Matter Expert for applicable technical changes in automation systems.
•    Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT).
•    Liaison with Business, Quality Assurance, Managed Services, and IT to coordinate the Change Request processes
•    Training:

• • cGxP
  • Applicable Corporate and Departmental Directives, Policies, and Procedures
  • Good Manufacturing Practices and Good Documentation Practices
  • Automation Control and Data Acquisition
  • EHS
  • Lab/Biological Safety
  • Gowning

Qualifications: 

• Expertise in IT Networking and industrial automation systems, such as Rockwell Automation (Allen Bradley RS Logix), Wonderware Archestra platform, TopView, Vaisala ViewLinc, Unicorn software, DeltaV, various Repligen and Thermo Scientific instruments is a plus.
• Bachelor of Science in Electrical Engineering, Computer Science, IT, Engineering, or related field of study with at least 5-7 years of related experience that provides direct scientific knowledge of automation systems operation and validation principles for computerized biologics production systems.
• Proven experience as an IT Automation Engineer or similar role.
• Direct knowledge of the biologics process equipment, SCADA/control systems, and supporting IT networking infrastructure.
• Expertise in scientific / technical subject areas – Equipment Qualification, Computer System Validation, SCADA system architecture, Biotech Process Equipment/Systems.
• Proficient in use of electronic systems, such as Microsoft Office, various specialized software including process documentation Veeva Vault, Material Management (SAP), Computerized Maintenance Management System (Maximo), Building Automation System (BAS).
• Knowledge of domestic / international regulatory guidelines / compendia and industry standards (FDA, ICH, USP and EMEA guidelines) for validation of computerized equipment and automation systems, including but not limited to 21 CFR Part 11, EU Eudralex Annex 11 and GAMP 5.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Comfort with collaboration, open communication, reaching across functional borders and being proactive.
• A strong focus on business outcomes.
• Ability to prioritize and juggle multiple concurrent projects and day-to-day requests

Please note that this role is based fully onsite in Pennington, New Jersey. The estimated salary range is $90,000 - $120,000 annually.

#PB

#LW

Job Title: SAP Engineer(MM/WM/PP/SD)

Location: Hopewell, NJ

The estimated salary range for this role is $110,000 - $120,000 depending on experience. 

Position Summary

ProBio is seeking an experienced SAP professional with strong hands-on knowledge of the SAP MM/WM/PP/SD modules to advance our SAP application landscape. The role requires deep functional expertise and business acumen, with proven experience in WM and PP being highly desirable.

Key Responsibilities (listed by importance, ≤10 items)

• Daily operation, maintenance, and administration of SAP MM/WM/PP/SD modules.
• Lead or support rollout projects and continuous-improvement initiatives related to MM/WM/PP/SD.
• Monitor master data integrity and business transactions within MM/WM/PP/SD; ensure compliance with SOPs.
• Gather business requirements, draft functional specifications, organize testing (UT, IT, UAT), and track post-go-live adoption.

Qualifications

• Education: Bachelor’s degree
• Major: Any discipline.
• Industry: Life-science or manufacturing preferred.
• Experience: Minimum 3 years of SAP MM/WM/PP/SD operation or implementation experience in one or more modules.
• Core Competencies:
• Able to independently perform customizing for any of MM/WM/PP/SD modules.
• SAP certification, SAP CSV validation experience, or ABAP development skills are advantages.
• Knowledge: Solid understanding of end-to-end business processes and key configuration points for any of MM/WM/PP/SD modules.
• Language: Fluent in Chinese and English (reading, writing, speaking).

#LI-EB1

#GS

Job Title: SAP Engineer(MM/WM/PP/SD)

Location: Pennington, NJ

The estimated salary range for this role is $110,000 - $120,000 depending on experience. 

Position Summary

ProBio is seeking an experienced SAP professional with strong hands-on knowledge of the SAP MM/WM/PP/SD modules to advance our SAP application landscape. The role requires deep functional expertise and business acumen, with proven experience in WM and PP being highly desirable.

Key Responsibilities (listed by importance, ≤10 items)

• Daily operation, maintenance, and administration of SAP MM/WM/PP/SD modules.
• Lead or support rollout projects and continuous-improvement initiatives related to MM/WM/PP/SD.
• Monitor master data integrity and business transactions within MM/WM/PP/SD; ensure compliance with SOPs.
• Gather business requirements, draft functional specifications, organize testing (UT, IT, UAT), and track post-go-live adoption.

Qualifications

• Education: Bachelor’s degree
• Major: Any discipline.
• Industry: Life-science or manufacturing preferred.
• Experience: Minimum 3 years of SAP MM/WM/PP/SD operation or implementation experience in one or more modules.
• Core Competencies:
• Able to independently perform customizing for any of MM/WM/PP/SD modules.
• SAP certification, SAP CSV validation experience, or ABAP development skills are advantages.
• Knowledge: Solid understanding of end-to-end business processes and key configuration points for any of MM/WM/PP/SD modules.
• Language: Fluent in Chinese and English (reading, writing, speaking).

#LI-EB1

#GS