Scientist II

Purpose:

Technical expert who independently investigates identifies develops and optimizes new methods/techniques for critical project needs to support both laboratory and commercial manufacturing processes. Apply scientific/engineering principles and statistical process design/analysis to develop robust antibody manufacturing processes. Act as lead scientist critically evaluate scientific/regulatory advances and integrate into R&D programs. Support manufacturing process validation regulatory submission and continuous improvement for late-stage and commercial manufacturing of ADCs. Requires in-depth knowledge of late-phase process transfer process validation process improvements. Strong cross-functional communication needed.

Major Responsibilities:

1. Resolve key project hurdles using technical expertise; support late-stage/commercial biologics manufacturing tech transfer process validation investigations troubleshooting scale-up continuous improvement
2. Work in dynamic/diverse team to support & troubleshoot current commercial manufacturing
3. Support/lead new product introduction at AbbVie sites or third-party manufacturers; ensure successful tech transfer scale-up validation
4. Support CMC life-cycle management and post-approval continued process validation for commercial antibody processes
5. Collaborate with process development on late-stage tech transfers scale-up and validation during transition to commercial manufacturing
6. Support product investigations/non-conformances; identify root causes; make scientific/quality recommendations
7. Author/review CMC sections of submissions; support agency inspections inquiries audits
8. Represent MSAT antibody group in CMC program teams; maintain strong internal/external relationships
9. Adhere to corporate standards (code of conduct safety GxP controlled substances animal care where applicable)

Qualifications :

. 7 years OR . 5 years relevant experience
Field: Biology Biochemistry Chemical or Biochemical Engineering or related fields
Effective writer/communicator of research or regulatory materials

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time