Executive Director, Upstream Process Development

About the Company

Flourishing biopharmaceutical company

Industry
Biotechnology

Type
Privately Held

Founded
2003

Employees
201-500

Categories

• Biotechnology
• Manufacturing
• Pharmaceuticals
• Medicine
• Chemical Products
• (I/O)
• ADC
• ADCs
• Antibody Drug-conjugates (ADC)
• Autoimmune Disorders
• Biopharm
• Biopharma
• Biotech
• Bispecific Antibodies
• CD74
• Cancer
• Cell-free Protein Synthesis
• Clinical Stage Drug Discovery
• Cytokine Based Imunno-oncology
• Endometrial Cancer
• FOLRa
• Folate Receptor Alpha
• I/O
• Linker
• Multiple Myeloma
• NHL
• Non-Hodgkin Lymphoma
• Oncology
• Ovarian Cancer
• SSF
• STRO-001
• STRO-002
• South San Francisco
• Sutro
• War Heads
• XpressCF Platform

About the Role

The Company is seeking an Executive Director for Upstream Process Development. The successful candidate will be a pivotal technical leader, driving the process development of the company's pipeline projects, with a specific focus on defining late-stage strategies for a novel cell-free protein synthesis platform. This role involves full ownership of strategy development, including risk assessment, process characterization, and implementation into the final stage of PPQ. The Executive Director will also be responsible for leading and directing all aspects of upstream process development, from pre-IND to commercial, and will serve as a key technical and CMC leader for the ongoing pipeline projects. Applicants must have a B.S., M.S., or Ph.D. in chemical engineering, life sciences, or equivalent, with a substantial background in the biopharmaceutical industry, particularly in microbial fermentation and cell culture process development. A strong foundation in late-stage process development, statistical design of experiments, and Quality by Design concepts is essential. The role requires a detail-oriented individual with excellent organizational and collaborative skills, a proven track record in communication, and the ability to work in a fast-paced, deadline-driven environment. Experience in scaling up and transferring processes, as well as in regulatory engagements and BLA authoring, is highly valued. The Executive Director will also be expected to lead, motivate, and develop technical staff, represent the company in various capacities, and contribute to the company's culture of inclusivity and diversity.

Hiring Manager Title
Chief Technical Operations Officer

Travel Percent
Less than 10%

Functions

• CEO/President
• Non-Profit Management
• Strategy
• General Management
• Operations