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Process Development ManagerApply remote type: Flex Commuter / Hybrid
Locations: Ireland - Dublin
Time type: Full time
Posted on: Posted 5 Days Ago
Job requisition id: R-219391
Career CategoryProcess Development
Job DescriptionJob Posting Title: Process Development Manager
GCF Level: 5
Career Category: Process Development
Location: ADL
Overview: The Process Development Manager will report to the Sr.
Manager Process Development for New Product Introduction (NPI) Technical Delivery.
The role involves overseeing the technical delivery of NPIs and lifecycle management products at ADL.
The ideal candidate will have 5-10 years of experience in the pharmaceutical or biotech industry, with proven skills in leading tech transfers, process validation, and team management.
Job Scope: This role requires managing a team of tech transfer engineers/scientists, leading tech transfers of NPIs and LCMs to ADL, and providing technical support for large and small molecule drug product manufacturing.
Responsibilities include:
Leading new product introductions and lifecycle changes from a Process Development perspective.Managing a team supporting vial and syringe transfers.Contributing to regulatory filings and responding to regulator questions.Providing technical solutions for drug substance processes and troubleshooting processing issues.Developing and characterizing drug product processes and transferring technology to commercial sites.Identifying operational opportunities and implementing process improvements.Leading risk assessments and CAPA implementation.Supporting validation plans and process performance qualifications.Ensuring compliance with quality and regulatory standards.Participating in validation and cross-functional teams.Leading investigations and root cause analyses.Supporting project management activities.Basic Qualifications: - Bachelor's degree in Science, Engineering, or related field with 5 years' experience OR Master's degree with 3 years' experience OR Associate's degree with 10 years' experience.
- Knowledge of cGMPs and regulatory requirements.
- Strong problem-solving and communication skills.
Preferred Qualifications: - PhD or Master's in Science or Engineering.
- 5+ years supporting commercial protein drug product processing, including sterile processing, process characterization, tech transfer, or validation.
- Expertise in protein biochemistry and process validation.
- Project management skills.
- Knowledge of quality systems, drug manufacturing, and validation.
- Leadership experience in cross-functional teams and excellent communication skills.
Amgen is an equal opportunities employer.
About UsAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.
A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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