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Clinical Manufacturing Team Leader

2 months ago

Philadelphia Pennsylvania, United States WuXi AppTec Full time

Overview:


WuXi AppTec is a premier global organization specializing in cell and gene therapy contract development, testing, and manufacturing. Our commitment is to propel the advancement and commercialization of innovative therapies that can transform patient lives.

We uphold values such as innovation, excellence, and collaboration, which guide our mission to expedite the development and accessibility of life-saving treatments for those in need.


Joining WuXi AppTec means becoming part of a vibrant, fast-evolving, and inventive atmosphere where you will engage with cutting-edge technologies and contribute significantly to patient care.

Our culture emphasizes teamwork and continuous improvement, fostering a supportive environment for all employees.

Benefits:
401K matching

PTO
Employee discount programs

Medical, dental, and vision insurance

and much more.


The Clinical Manufacturing Team Leader is tasked with providing direct oversight and guidance in the clinical production of Master and Working Cell Banks, ensuring compliance with current Good Manufacturing Practices (cGMPs) during the manufacturing of Cell & Gene Therapy products and final product fills.


Key Responsibilities:
- Oversee, train, and mentor team members on fundamental aseptic operational techniques, including solution and material preparation, as well as facility start-up engineering and mechanical knowledge.

- Educate and guide others on all operational functions, equipment capabilities, and perform advanced troubleshooting.

- Manage the sourcing and procurement of standard and complex equipment.

- Review and approve solution and material preparation results, addressing any issues that arise.

- Evaluate protocols and other technical transfer documents.

- Identify and implement GMP concepts, recommending improvements throughout the technical transfer phases.

- Conduct in-house and offsite validation activities.

- Forecast and manage material procurement activities.

- Utilize all support systems (e.g., LIMS) proficiently, acting as a subject matter expert (SME) or super user.

- Lead or participate in teams focused on system design or improvements.

- Understand and apply manufacturing processes and methods effectively.

- Train and mentor team members on operations such as media preparation, thawing, passage, harvesting, and specific unit operations across assigned programs.

- Analyze data and draw actionable conclusions.

- Identify process gaps and opportunities for improvement across assigned programs.

- Collect, record, review, and analyze scientific and process data following good documentation practices.

- Communicate scientific and process data to internal and external stakeholders, recommending pathways for further processing.

- Ensure compliance with regulatory requirements and cGMPs, understanding the rationale behind these regulations.

- Address and improve complex cGMP compliance and regulatory issues across assigned programs.

- Ensure team members are trained on Batch records, SOPs, equipment, and all unit operations.

- Author, review, and approve technical documents related to non-conforming events and deviations.

- Champion continuous improvement initiatives.

- Manage scheduling, forecasting, and performance of work assignments to ensure adequate staffing across programs.

- Collaborate with cross-functional teams regularly.

- Communicate organizational updates and job expectations to support team performance.

- Monitor and evaluate direct reports' performance, including competencies and goals.

- Provide coaching, counseling, and conduct disciplinary actions as necessary.

- Develop and adhere to organizational systems, policies, and procedures, following labor and capacity standards.

Qualifications:
- High School Diploma or equivalent required; 5+ years of relevant technical experience with a minimum of 2 years in a leadership role.

- Bachelor’s degree in a science-related field preferred, or a combination of relevant experience and education.

Knowledge / Skills / Abilities:
- Demonstrated knowledge of Lean/Six Sigma principles is desirable.

- Proficient in performing arithmetic calculations, including fractions, decimals, percentages, and basic algebraic and geometric calculations.

- Strong understanding of Good Laboratory Practices and Good Manufacturing Practices.

- Basic financial knowledge and acumen.

- Fundamental engineering and mechanical knowledge applicable to the manufacturing environment.

- Technical expertise in the pharmaceutical and biotechnology sectors, particularly in cell and gene therapy.

- Excellent oral and written communication skills; proficiency in English is required.

- Proficient in Microsoft Office Suite (Excel, Word, Outlook).

Our Values:
Integrity & Dedication, Collaboration & Shared Success; Upholding Ethical Standards and Excellence in Execution.


At WuXi AppTec, our greatest asset is our people. We are committed to providing opportunities for internal growth, supported by a dedicated Human Resources team.


WuXi AppTec is an equal opportunity employer, welcoming individuals regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by law.