Scientist II, Global Technical Operations Full-time

Job Title

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:

• B.Sc. + 7+ years, OR M.Sc. + 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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Where We Work:

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.