• Full Time (Salaried)
  • , CA

Company:  Confidential

Job Title: AD, Downstream Process Development

Job Number: 34931

Location: , CA

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.

Responsibilities

  • 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

 

Apply for job

To apply for this job please visit k7y.pl.