Senior Scientist, Pharmacy I
AbbVie
5 hours ago
On-site
North Chicago, IL
Operations
The Senior Scientist, Drug Product/Parenteral Expert serves as the technical subject matter expert for drug product and parenteral development across pipeline and commercial products within Eye Care and Novel Therapies.
Key Responsibilities:
- Act as the Drug Product lead for pipeline and marketed products.
- Lead or support process development for eye care and gene therapy products, including solution, suspension, lyophilized, and other injectable dosage forms.
- Drive development of drug product strategies aligned with target product profiles, quality attributes, and clinical/commercial requirements.
- Provide technical oversight for process development, process characterization, scale-up, validation, and tech transfer activities.
- Support manufacturing issue resolution, deviation investigations, root cause analysis, and implementation of corrective and preventive actions.
- Partner with internal and external manufacturing sites, CMOs, and vendors to ensure product robustness and supply reliability.
- Contribute to CMC documentation for regulatory submissions, technical reports, responses to agency questions, and lifecycle changes.
- Evaluate and implement innovative drug product solutions for novel therapies.
- Assess product stability, compatibility, container closure systems, and storage/shipping considerations.
- Collaborate with Quality, Regulatory, Analytical, and Clinical teams to ensure alignment on development strategy and execution.
- Mentor junior scientists and contribute to scientific capability building.
- Represent drug product expertise in cross-functional governance forums and project teams.
Qualifications:
- PhD, PharmD, or MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or related scientific discipline.
- Typically 6+ years of relevant industry experience for a Grade 17 level, or equivalent combination of education and experience.
- Experience with process development and/or commercial product support, aseptic processing, sterile manufacturing, process validation.
- Demonstrated understanding of CMC principles, GMP requirements, and technical transfer.
- Proven ability to work effectively in cross-functional and matrixed environments.
- Strong scientific judgment, problem-solving skills, and communication skills.
Preferred Qualifications:
- Experience supporting ophthalmic or eye care products.
- Experience with novel modalities or advanced therapeutic platforms.
- Knowledge of container closure systems, extractables/leachables, and stability programs.
- Experience with global regulatory filings and product lifecycle management.
- Prior experience with external partners or contract manufacturing organizations.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (for eligible employees).
- Eligible to participate in short-term incentive programs.
Key Responsibilities:
- Act as the Drug Product lead for pipeline and marketed products.
- Lead or support process development for eye care and gene therapy products, including solution, suspension, lyophilized, and other injectable dosage forms.
- Drive development of drug product strategies aligned with target product profiles, quality attributes, and clinical/commercial requirements.
- Provide technical oversight for process development, process characterization, scale-up, validation, and tech transfer activities.
- Support manufacturing issue resolution, deviation investigations, root cause analysis, and implementation of corrective and preventive actions.
- Partner with internal and external manufacturing sites, CMOs, and vendors to ensure product robustness and supply reliability.
- Contribute to CMC documentation for regulatory submissions, technical reports, responses to agency questions, and lifecycle changes.
- Evaluate and implement innovative drug product solutions for novel therapies.
- Assess product stability, compatibility, container closure systems, and storage/shipping considerations.
- Collaborate with Quality, Regulatory, Analytical, and Clinical teams to ensure alignment on development strategy and execution.
- Mentor junior scientists and contribute to scientific capability building.
- Represent drug product expertise in cross-functional governance forums and project teams.
Qualifications:
- PhD, PharmD, or MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or related scientific discipline.
- Typically 6+ years of relevant industry experience for a Grade 17 level, or equivalent combination of education and experience.
- Experience with process development and/or commercial product support, aseptic processing, sterile manufacturing, process validation.
- Demonstrated understanding of CMC principles, GMP requirements, and technical transfer.
- Proven ability to work effectively in cross-functional and matrixed environments.
- Strong scientific judgment, problem-solving skills, and communication skills.
Preferred Qualifications:
- Experience supporting ophthalmic or eye care products.
- Experience with novel modalities or advanced therapeutic platforms.
- Knowledge of container closure systems, extractables/leachables, and stability programs.
- Experience with global regulatory filings and product lifecycle management.
- Prior experience with external partners or contract manufacturing organizations.
Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (for eligible employees).
- Eligible to participate in short-term incentive programs.