Engineer II, Drug Product Manufacturing

WuXi Biologics; Cranbury Township (NJ); On-site; USD 66,000 - 106,000; Full time

Job summary

WuXi Biologics is seeking an Engineer I, Drug Product Manufacturing in Robbinsville, NJ to join the DP manufacturing team. You will supervise technicians, contribute to aseptic fill/finish operations, and ensure cGMP compliance in a busy clinical DP facility.

The role emphasizes leadership, training, SOP development, and collaboration with internal teams and external partners. Occasional travel and shift work may be required.

Qualifications

• Must have strong knowledge of cGMP and biologics drug product manufacturing processes.
• Experience supervising manufacturing support teams in a regulated environment.
• Ability to develop, review and implement SOPs for GMP aseptic fill/finish operations.
• Proven communication and leadership skills with internal and external stakeholders.

Responsibilities

• Oversee aseptic fill/finish operations support activities and related batch records.
• Train, coach and supervise drug product manufacturing support team.
• Ensure equipment, SOPs, and training are in place and up-to-date.
• Maintain inspection readiness and document control for the DP suite.
• Support schedule execution and staffing across activities.

Skills

cGMP knowledge

DP manufacturing support

Team leadership

Quality compliance

Education

Bachelor's degree or higher in life sciences/engineering

Job description

Job Title – Engineer I, Drug Product Manufacturing

Work Location – Robbinsville NJ

First, Second or Third shift available

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

Job Summary

This is a full-time position, reporting to the Manufacturing Head of DP12. The Engineer I of Drug Product Manufacturing will be a key member of the Manufacturing team and will work independently and in a team to contribute to the qualification, operation and overall success of the clinical drug product manufacturing facility. This includes but is not limited to supervising a team of technicians responsible for the manufacturing support activities in drug product manufacturing, such as buffer preparation, visual inspection of finished product, and other tasks as assigned. Responsible for providing direct oversight, coaching, mentoring and leadership in the drug product manufacturing activities according to current Good Manufacturing Practices (cGMPs).

Responsibilities

• Be responsible for all supporting activities related to aseptic cGMP compliant fill/finish operation, including but not limited to buffer preparation, formulation and compounding operation, visual inspection of finished product.
• Learn, train and supervise drug product manufacturing supporting team for the execution of manufacturing support activities.
• Maintain the drug product suite in an inspection-ready state.
• Develop, author, review and approve SOPs/protocols for manufacturing related activities for GMP aseptic fill/finish operation.
• Responsible for ensuring manufacturing team members are trained on batch records, SOPs, equipment, and all relevant trainings as required.
• Accountable for schedule execution, adjustments, and performance of work assignments for team to ensure adequate staffing across assigned activities.
• May be required to work Shifts, Holidays and weekends.
• Other duties as assigned.

Qualifications

• GED with 8 – 10 year experience, or Associate/Bachelor degree with 3-5 year experience, Masters with 1-3 year experience in life sciences, engineering or other related fields or highly regulated industry.
• Must possess extensive knowledge and experience in drug product manufacturing support operations and have solid understanding of cGMP compliance requirements for a manufacturing facility. Previous experience in buffer preparation and visual inspection are preferred.
• Proven experience in risk mitigation planning and ability to solve complex manufacturing operation support related problems. Ability to make appropriate judgment and rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
• Proven track record of supervising manufacturing team in manufacturing industry. Excellent communications skills. Great team player and ability to build positive collaboration with internal stakeholders, 3rd party contractors and clients to achieve alignment and work effectively.
• Must work in a self-motivated, highly flexible, well organized and detailed-oriented style in this leadership position with requirement of some evening conference call time and occasional international travel.
• Previous supervisory experience preferred.

Knowledge

• Incumbent shall display strong knowledge and understanding of
  • Current Good Manufacturing Practices.
  • Biologics drug product manufacturing processes and procedures

Behavioral Competencies

• Incumbent shall display strong and effective:
  • Teamwork
  • Interpersonal/Communication Skills
  • Personnel management
  • Project management
  • Business acumen/commercial awareness

Onerous Requirements

Position may require occasional travel to global WuXi Biologics sites and/or client sites.

Position is individual contributor role for manufacturing facility and may require occasional night and weekend hours.

The anticipated base pay range for this position is $66,200 to $105,900

WuXi Biologics 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, or protected veteran status and will not be discriminated against on the basis of disability