• , US

Company:  Confidential

Job Title: AD, Downstream Process Development

Job Number: 79519

Location: , US

Job Description

In this role, you will oversee downstream process development and manufacturing of early and late stage clinical biologics programs. It is a hybrid position, being onsite 2-3 days per week.


* Act as a subject matter expert for downstream process development, collaborating with external vendors to oversee, develop, and optimize downstream unit operations in a phase-appropriate manner. * Serve as the technical lead for downstream process technology transfer and manufacturing activities. * Lead downstream process characterization and PPQ using a risk-based approach. * Develop experimental plans, oversee the execution of experiments, and analyze data using statistical methods as needed. * Author and review protocols, reports, batch records, and regulatory documents. * Present data and communicate plans at project team meetings. * Lead troubleshooting and investigation of critical deviations. * Support the selection of CDMOs. * Collaborate with QA, Regulatory Affairs, and other functions to generate and manage GMP and regulatory documents. * Manage the budget and accounting for drug substance work.

Required Skills

* MS or PhD in Chemistry, Biology, or Engineering with over 5 years of industry experience for PhD holders or over 12 years for MS holders in biologics drug substance downstream development. * Expert in biologics protein purification and downstream process development. * Experienced in large-scale chromatography, ultrafiltration, viral inactivation, and filtration. * Proficient in late-phase downstream process characterization and PPQ. * Familiarity with upstream process development is a plus. * Experienced in overseeing external CRO resources for drug substance production. * Knowledgeable and experienced in operating within the biologics CMC regulatory environment from early to late-stage development. * Well-versed in GMP/ICH regulations with a strong focus on quality. * Strongly desired: Working knowledge of quality by design and risk management. * Team-oriented professional with excellent organizational, communication, leadership, and problem-solving skills. * Proven ability to efficiently coordinate multiple work streams and development efforts.Salary range: $230,000/year Benefits: Health Insurance (medical, dental, vision) Life Insurance Short- and Long-Term Disability 401(k) Paid Time Off

Application Deadline: 2024-07-08


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