About the position
WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics' achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies. Responsible for providing direct oversight, coaching, mentoring and leadership in the manufacture of biologics products performing activities within production facilities to support manufacture of upstream operations according to current Good Manufacturing Practices (cGMPs).
Responsibilities
- Understands, oversees, trains, coaches, mentors and manages performance of others on basic aseptic operational techniques as well as, performing solution, material preparation, cell culture, and purification along with analyzing results and facility start-up engineering and mechanical knowledge
- Reviews and approves manufacturing SOPs/ protocols, executed manufacturing documentation/ results and resolves issues
- Identifies and drives application of GMP concepts and is able to recommend and identify improvements as the process develops during phases of technical transfer
- Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific
- Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing
- Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues, champions continuous improvement ideas
- Responsible for ensuring employees are trained on Batch record, SOPs, equipment, all unit operations and non-manufacturing SOPs and systems
- Accountable for schedule execution, adjustments and performance of work assignments for team to ensure adequate staffing across assigned activities
- Regularly interacts with and supports cross-functional teams
- Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
- May be required to work Shifts, Holidays and weekends
- Other duties as assigned
Requirements
- BS/BA in Science related field preferred or HS Diploma; or combination of relevant Experience & Education
- 5+ years relevant technical experience and min 3 years in a Lead/Leadership/Supervisory Role
- Demonstrated Lean / Six Sigma knowledge desired
- Ability to perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations accurately and reproducibly
- Thorough understanding of Good Manufacturing Practices
- Has basic financial knowledge and acumen
- Possesses basic and fundamental engineering and mechanical knowledge and is able to apply it 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 biologics production
- Proficient in Oral & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
