Senior Engineer (Drug Substance Process Engineering)

Holly Springs, NC, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Welcome to Amgen, a biotechnology company that strives to transform the lives of patients through innovative medicines. We are currently seeking a talented and experienced Senior Engineer in Drug Substance Process Engineering to join our dynamic team.As a Senior Engineer, you will play a crucial role in developing and optimizing drug substance manufacturing processes to ensure the production of high-quality medicines. Your expertise and leadership will be essential in driving continuous improvement and efficiency in our manufacturing operations.To excel in this role, you must have a strong background in chemical or biochemical engineering and extensive experience in process development and scale-up. You should also have excellent problem-solving skills, a passion for innovation, and the ability to collaborate effectively with cross-functional teams.If you are ready to make a meaningful impact in the biotechnology industry and help us bring life-changing medicines to patients, we invite you to apply for this exciting opportunity at Amgen.

Develop and optimize drug substance manufacturing processes to meet quality, safety, and efficiency standards.
Lead and manage process improvement projects to drive continuous improvement in manufacturing operations.
Utilize your expertise in chemical or biochemical engineering to troubleshoot and resolve complex technical issues.
Collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to ensure successful process transfer and implementation.
Conduct process scale-up and technology transfer activities from development to commercial production.
Analyze process data and perform statistical analysis to identify areas for improvement and optimize process performance.
Develop and maintain process documentation, including process descriptions, batch records, and standard operating procedures.
Stay current with industry advancements and innovative technologies to identify opportunities for process improvement and innovation.
Train and mentor junior engineers and provide technical guidance to support their development.
Ensure compliance with regulatory requirements and company policies and procedures.
Communicate effectively with internal and external stakeholders to provide updates on project progress and address any concerns.
Represent the company in technical discussions and presentations with clients and partners.
Maintain a safe and clean working environment in accordance with company and regulatory standards.
Participate in cross-functional teams to support new product development and launch activities.
Demonstrate a strong commitment to Amgen's mission and values and contribute to a positive and collaborative work culture.

Where is this job?

This job is located at Holly Springs, NC, USA

Job Qualifications

Extensive Experience In Drug Substance Process Engineering: This Includes A Deep Understanding Of Pharmaceutical Manufacturing Processes And Equipment, As Well As A Track Record Of Successfully Developing And Implementing New Processes.
Strong Leadership And Project Management Skills: As A Senior Engineer At Amgen, The Individual Will Be Expected To Lead Cross-Functional Teams And Manage Complex Projects From Conception To Completion.
Knowledge Of Regulatory Requirements: The Ideal Candidate Should Have A Thorough Understanding Of Fda Regulations And Guidelines, As Well As Experience With Regulatory Submissions And Inspections.
Excellent Problem-Solving And Analytical Skills: Senior Engineers At Amgen Are Expected To Identify And Address Process Issues, Troubleshoot Technical Problems, And Develop Innovative Solutions To Improve Efficiency And Quality.
Excellent Communication And Collaboration Skills: The Role Of A Senior Engineer Involves Working Closely With Cross-Functional Teams, As Well As Communicating With Stakeholders At Various Levels Within The Company. Strong Communication And Collaboration Skills Are Essential For Success In This Role.

Required Skills

Project Management
Data Analysis
Quality Control
Technical Leadership
Risk assessment
Process optimization
Process development
GMP compliance
Equipment validation
Process
Scale-Up
Manufacturing Operations

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving

Compensation

According to JobzMall, the average salary range for a Senior Engineer (Drug Substance Process Engineering) in Holly Springs, NC, USA is $102,000 - $140,000 per year. This may vary depending on the specific company, industry, and years of experience.

Additional Information

Amgen is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedAugust 13th, 2024

Apply BeforeJuly 20th, 2025

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