Overview

STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations across Asia, North America and Europe. As an innovative Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Controls) solutions from preclinical to commercial.

STA Pharmaceuticals is constructing a new greenfield CDMO facility to manufacture finished drug products in Middletown, Delaware. The facility will be a four (4) building campus with 460,000 sq. ft. of office, laboratory, and manufacturing spaces. The facility is currently under construction with a planned first phase completion date at the end of 2025.

We are seeking a self-motivated person in the role of a Process Engineering Project Lead to join our team. This position will be a key contributor in the initial construction phase and play a key role in the transition process to operationalize the site in late 2025 or the first half of 2026.

Qualifications

Experience / Education:

• Minimum of BS in Chemical Engineering or related discipline with 8 years of relevant experience in a pharmaceutical drug products environment or MS degree with 6 years.
• Significant experience in pharmaceutical process R&D / engineering work
• CMO/CRO experience is highly desirable.
• Strong working knowledge of and experience with the following drug products manufacturing processes – Oral Solid Dosage and Packaging

Knowledge / Skills / Abilities:

• Demonstrated in-depth understanding of cGMP manufacturing for pharmaceutical products.
• Demonstrated success working effectively outside defined scope of responsibility, when required.
• Self-motivated with an ability prioritize and plan activities.
• Completes task with a sense of urgency.
• Ability to provide technical and trouble-shooting support for manufacturing technology process activities. Knowledge of analytical testing techniques is a plus.
• Good oral and written communication skills. Can provide technical updates to internal and external partners.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Responsibilities

Project Construction Phase

Throughout the site construction project phase, the Project Team operates at a rapid pace, managing large-scale and intricate construction and engineering tasks. In this start-up-like environment, the pace is fast, and changes are constant. Adaptability, proactivity, and a willingness to embrace uncertainties are essential. The successful incumbent will thrive on taking initiative, excel at wearing multiple hats, and can switch roles swiftly as circumstances evolve. Collaboration is critical at this dynamic setting, with open communication and a team-first attitude driving success.

• Role scope of this position consists of the following technical objects in areas of OSD process suites but not limited to: (OSD: Oral Solid Dosage)
  • Weighing and dispensing units
  • Material handling and sieving/blending units
  • Granulation process equipment system, include roller compacting dry granulation, wet granulation and fluid bed drying process equipment system
  • Tablet compression equipment system
  • Capsule filling process equipment system
  • Tablet coating process equipment system
  • Packaging equipment of drug products, include blister, cartooning and bottle filling packaging line system
  • Utilities that applied for supporting those above system functional operation,

• The individual will be responsible leading the collaboration of the different external and internal partners to ensure the manufacturing process engineering meets the operational intent of the project while driving innovation by identifying and evaluating new technology opportunities.
• Develops and manages plans for the start-up, commissioning, qualification of the new drug products facilities while ensuring the project is delivered on time and budget at the high quality.
• Collaborates with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as process design, commissioning, qualification, and validation documentation is reviewed and approved.
• Reviews and approves facility and equipment qualification documentation and quality system documentation to support ongoing site projects.
• The individual will be responsible for coordinating the qualification activities with the internal and external stakeholders for their respect manufacturing process trains to meet the defined timelines.
• The individual will be responsible for interacting with the engineering design team in the development and alignment of the designed process with the other Global facilities.
• Develops risk analysis and cost reviews for their respective manufacturing process area, while maintaining project timelines.
• Facilitates problem solving activities and develops planning to results in solving project difficulties to ensure project delivery on time and within budget.
• The individual will keep close cooperation with the Site Leadership Team and will support the creation of a culture that aligns with the Company’s core values of integrity & dedication, working together, doing the right thing, and doing it right.

Routine Operations Phase (post construction)

• Per individuals strength and personal development, this position will be transitioning into the role either in individual SME or team leader with management responsibility,
• Develop, lead and continuously improve the DP process engineering organization including developing required capabilities, process, technical system and tools in supporting DP business growth
• Aids in the development of operational and quality procedures to support the overall site and drug products facilities.
• Designs and completes complex research as needed to support manufacturing projects.
• Assists in the implementation of site quality system to meet regulatory requirements and customer expectations.
• Assists during Health/Regulatory Authority inspections and ensures successful completion of these inspections.
• Demonstrates thorough understanding of, and implements, Good Laboratory Practices and Good Manufacturing Practices
• The individual will be working directly with external clients to create process risk assessment and transfer plans.
• Assists environmental health and safety (EHS) staff in the development of procedures and practices to support a strong safety culture.
• Leads deviation investigation to resolve issues in a timely manner to ensure smooth progress of the site projects.
• Performs other duties as assigned to support technical projects.
• The individual will ensure compliance with all Company, local, state, and federal policies and procedures and international authority requirements for quality and compliance.