30 days old

Commercial Advancement, Final Product Technical Lead

Amgen
Thousand Oaks, CA 91360
  • Job Code
    125488116
Amgen

Job ID: R-105194
Location: Thousand Oaks, CA, US

The Final Product Technical Lead (FPTL) is an experienced professional scientific/engineer with a broad set of knowledge and expertise in leading complex, multi-disciplinary and cross-functional product development efforts. Requirements for this role:
  • Single Point of accountability for the portfolio of final product presentation(s) within a given (drug) product
  • Member of the Product Delivery Team (PDT) and represents all final product presentation technical activities on the PDT
  • Represents all final product presentation content to the PDT and per the external development partner engagement model to ensure delivery of the technical and project content and data necessary to enable the product strategy
  • Drives development of business case, scenario planning, and prioritization within FPT. Ensures there are adequate resources and budgets on the final product presentation sub-teams to execute required work. Collaborates with Platform Teams for respective presentations and technical reviews.
  • Responsible for post launch surveillance activities and APRs for specific products.
  • Responsible for communication related to key program status, critical technical, supply, and compliance risk
  • Accountable for product improvement initiatives in partnership with commercial and marketing
  • Partners with and advises other PDT members as appropriate
  • Partners with and advises other PDT members as appropriate. Responsible for representing device, container, secondary packaging, labelling, and human factors functions to the PDT.

Responsibilities:
  • Contributes proactively to the development of technically viable final and or combination product presentations and SKU strategies in alignment with the Target Product Profile/Product assumptions and Quality Target Product Profile (QTPP) for commercialization
  • Ensures fit to platform for the design of final product, drives decision related to platform adherence and deviations, and ensures design of combination product systems and vial presentations as well as packaging and device assembly manufacturing processes are robust
  • Provides technically viable solutions to drives presentation selection
  • Advisor during "the end of FIH assessment" to make recommendations on the future development of the molecule and process
  • Ensures appropriate CMC sections of all regulatory filings are authored (primary author or delegates to team members) Drives in-depth technical reviews of the final product presentation design and assembly/labeling/packaging process requirements as needed
  • Ensures adherence to the final product design and alignment on FPT related technical decisions for advancing the commercial product design through in-depth integrated product technical reviews. at the drug product technical review (D(PTR)
  • Provides technical support to commercial manufacturing sites, external supply, and quality, as needed

Basic Qualifications:

Doctorate degree and 2 years of engineering experience
OR
Master's degree and 6 years of engineering experience
OR
Bachelor's degree and 8 years of engineering experience
OR
Associate's degree and 10 years of engineering experience
OR
High school diploma / GED and 12 years of engineering experience

Preferred Qualifications:

Strong interpersonal skills and highly effective communicator with strong executive presence

Ability to navigate across complex matrix organization and influence team members to ensure execution

15+ years of progressive experience as an engineer or scientist within the appropriate field of study

5+ years of experience in project leadership within a development or research, manufacturing environment, working with CMC, Medical Devices, ideally Class II and Class III

Proficient understanding of combination product development and lifecycle management

Experience in tech transfer, product manufacturing, and commercial scale up/global launch strategies

Familiar with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), and Medical Electrical Equipment (EN 60601).

Country (State/Region)

California, US

Location (City)

Thousand Oaks

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.



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Posted: 2020-11-01 Expires: 2020-12-02

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Commercial Advancement, Final Product Technical Lead

Amgen
Thousand Oaks, CA 91360

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