Senior Manager, Manufacturing Support

Job Title – Senior Manager, Manufacturing Support

Location – Worcester MA

WuXi Biologics is a 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.

Summary

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
  
  
  
  

Qualifications

• 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
  
  
  
  

Physical Requirements

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to Lift/ push pull 50 lbs routinely
• Ability to crouch, bend, twist, and reach
• Clarity of Vision and have the ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs / Scaffolding
• Ability to work in variable temperatures high to freezing
• Inside/outside working conditions
  
  
  
  

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

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.