Manufacturing Specialist-Process Engineer

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen in the United States seeks a Manufacturing Specialist to support execution of manufacturing and quality systems, including continuous improvement and technology transfer. You will apply scientific expertise to optimize processes, train staff, and lead cross-functional initiatives.

The role emphasizes process ownership, risk assessments, and adherence to GMP while contributing to regulatory readiness and continuous improvement programs.

Qualifications

• Doctorate degree required.
• Master’s degree with 2+ years in engineering, manufacturing, packaging or quality in pharma/biotech.
• Bachelor’s degree with 4+ years in related fields in pharma/biotech.
• Associates degree with 8+ years in relevant roles in pharma/biotech.
• High school diploma with 10+ years in engineering/manufacturing/quality in pharma/biotech.

Responsibilities

• Apply process expertise; initiate, revise, and approve manufacturing procedures reflecting current operations.
• Lead continuous improvement and support technology transfer / new product introductions.
• Assist in process monitoring, data review, and quarterly reports for deviations.
• Support NPIs, documentation, training, and equipment modification projects.
• Participate in investigations, CAPA closure, and trend evaluations.
• Assist with process validation protocols and data analysis.
• May participate in regulatory inspections and change control activities.

Skills

Bio-processing

Lean / Operational Excellence

GMP knowledge

Cross-functional teams

Data analysis

Education

Doctorate degree

Master’s degree + 2 years in Eng/Manufacturing/Packaging/Quality (pharma/biotech)

Bachelor’s degree + 4 years in Eng/Manufacturing/Packaging/Quality (pharma/biotech)

Associates degree + 8 years in Eng/Manufacturing/Packaging/Quality (pharma/biotech)

High school diploma / GED + 10 years in Eng/Manufacturing/Packaging/Quality (pharma/biotech)

Job description

Job Description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Specialist, Manufacturing

What you will do

Lets do this. Lets change the world. This role will support the execution of manufacturing/quality systems such as continuous improvement, technology transfer / new product introductions, process validation, manufacturing process/procedures, risk assessments, training, and non-conformance. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations. You may also serve as the primary production process owner for process support systems and assist with process ownership responsibilities on process systems.

Responsibilities may include, but are not limited to:

Applied Process Expertise

As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations. Assess process performance by; observation of floor operations, review of performance data and provide troubleshooting support. Evaluate, plan, and implement solutions for process improvement opportunities. Assist in generation of training materials and / or in providing training on scientific or technical aspects of the process. Complete risk evaluations for new processes or changes to existing processes and issue the summary reports of these evaluations.

Projects and Initiatives

Bring continuous improvement initiatives for cost reduction or cycle time reduction and participate in the assessment or implementation of such special projects or initiatives.

Process Monitoring

Support process monitoring parameters and control limits based off critical metrics and recommend improvements. Collect process-monitoring data and support the assessment of deviations. Provide support of timely process monitoring quarterly reports.

Technology Transfer / New Product Introductions & Process or Equipment Modifications

Participate in technology transfer / NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Non-Conformance and CAPA

Ensure that all Non-conformance are triage within the established goal. Assist with investigations, corrective actions and NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation

Assist with the process validation and generation of process validation protocols and reports. Support collection and analysis of process validation data.

Regulatory

May participate in regulatory inspections.

Change Control

As manufacturing change owner, provide assessments on CCRB records impacting the process.

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications

Doctorate degree

Or

Masters degree and 2 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

Bachelors degree and 4 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

Associates degree and 8 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Or

High school diploma / GED and 10 years in Engineering, Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Preferred Qualifications

• Detailed technical understanding of bio-processing and manufacturing operations
• Develop, manage, and implement process improvements
• Experience with Lean principals (Kaizen, Six Sigma, Operational Excellence) and knowledge of problem-solving techniques
• Experience in participating and helping lead cross-functional teams
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality
• Experience with change control process and change management
• Skilled in performance of GMP production operations
• Regulatory knowledge and interactions
• Project management skills
• Excellent organizational, technical writing, presentation, and verbal skills
• Knowledge of data analysis and control charting

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Sponsorship

Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.