Supervisor Manufacturing

WuXi AppTec; Philadelphia (Philadelphia County); On-site; USD 70,000 - 90,000; Full time

Job summary

WuXi AppTec is seeking a Manufacturing Supervisor to provide leadership in the manufacturing of Cell & Gene Therapy products. This role involves overseeing operations, ensuring compliance with cGMPs, and leading a team in a fast-paced laboratory environment. Ideal candidates will have over five years of technical experience, strong leadership skills, and a solid understanding of manufacturing processes. Join us to contribute to the advancement of life-saving therapies.

Benefits

401K matching

PTO

Employee discount programs

Medical, dental and vision insurance

Qualifications

• 5+ years relevant technical experience.
• Min 2 years in a Lead/Leadership/Supervisory Role.
• Thorough understanding of Good Laboratory and Manufacturing Practices.

Responsibilities

• Oversees and manages performance of others in manufacturing.
• Trains and coaches on operational techniques and compliance.
• Executes in-house and offsite validation activities.

Skills

Lean / Six Sigma knowledge

Good Laboratory Practices

Good Manufacturing Practices

Communication skills

Arithmetic calculations

Education

HS Diploma or equivalent

BS/BA in Science related field

Tools

Microsoft Excel

Microsoft Word

Microsoft Outlook

Job description

Manufacturing Supervisor (Thurs – Sat and Alternating Wednesdays, 12hr Shifts, 2 pm - 2:30am)

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.

Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.

Our benefits include:

• 401K matching
• PTO
• Employee discount programs
• Medical, dental and vision insurance
• and much more

The Manufacturing Supervisor is responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

After training has been completed on 1st shift, the supervisor will work the following:

Quad 4: Thurs – Sat and Alternating Wednesday’s, 12hr Shifts, 2pm-2:30am

Responsibilities

• Understands, oversees, trains, coaches, mentors and manages performance of others on basic aseptic operational techniques as well as, performing solution, material preparation, analyzing results and facility start-up engineering and mechanical knowledge. • Understands, teaches and coaches others on all operations, functions, capability of equipment and ancillary support to equipment and is able to perform complex troubleshooting• Drives sourcing and purchasing of standard, new and complex equipment• Reviews and approves solution and material preparation results and resolves issues• Reviews protocols and other technical transfer documents• Identifies and drives application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer• Executes in-house and offsite validation activities• Forecast and performs material procurement activities• Uses all support systems (e.g. LIMS) with demonstrated proficiency and able to act as an subject matter expert (SME) and/or Super user on a system• Acts a lead, member or Champion that helps to design the new system or of a systems improvement team • Understands the concept of and has performed or experience with manufacturing processes and methods• Trains, coaches mentors and manages performance of others on basic operations such as media preparation, thaw, passage and harvesting and specific unit operations and overall systems across assigned programs, in the manufacturing process• Interprets data and draws conclusions• Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific

• Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices• Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing• Follows compliance and regulatory requirements and current Good Manufacturing Practices (cGMPs) and understands ‘why’ behind the regulations• Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues across assigned programs and site specific• Responsible for ensuring employees are trained on Batch record, SOPs, equipment, all unit operations and non-manufacturing SOPs and systems• Authors, reviews and approves technical documents such as non-conforming events and deviations• Identifies, suggests, participates, leads, implements and champions continuous improvement ideas• Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across assigned and site specific programs• Regularly interacts with and supports cross-functional teams. • Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work • Plans, monitors, and appraises direct reports including performance competencies, goals & job results• Coaches, counsels, and conducts disciplinary actions

Qualifications

• HS Diploma or equivalent required and• 5+ years relevant technical experience and min 2 years in a Lead/Leadership/Supervisory Role• BS/BA in Science related field preferred; or combination of relevant Experience & Education

Knowledge / Skills / Abilities:

• Demonstrated Lean / Six Sigma knowledge, desired• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices• Has basic financial knowledge and acumen• Possesses basic and fundamental engineering and mechanical knowledge and is able to apply in the manufacturing area demonstrating unit operational and end-to-end understanding• Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy.• Proficient in Oral & Written communication skills• Need to be able to read, write and understand English • Proficient in Microsoft (Excel, Word, Outlook)

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

About the company

WuXi AppTec is a global pharmaceutical, biopharmaceutical, and medical device company.

Notice

Talentify is 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, disability, or protected veteran status.

Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at [e-mail] or 407-000-0000.

Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.

An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at [e-mail] or 407-000-0000.