Contract – Associate Director, Biologics Upstream Technical Operations

CONTRACT – ASSOCIATE DIRECTOR, BIOLOGICS UPSTREAM TECHNICAL OPERATIONS

Position Summary:

We are looking for exceptional individuals who share our passion for great science and an authentic commitment to develop and deliver life-changing treatments for people living with grievous blood-based disorders, starting with Sickle Cell Disease   

The ideal candidate owns and will oversee all cell culture production, validation, and commercialization activities of GBT biologic compounds for the treatment of Sickle Cell Disease (SCD).  Responsibilities will mainly focus on the development and execution of a BLA enabling GMP process characterization and process validation of a monoclonal antibody.  The candidate will develop strategies and manage study execution and data generation for applicable global regulatory submissions.  Deliverable expectations to include:

• Plan, Design and execute major BLA enabling projects through sound DOE and statistical analysis; early risk assessments and thorough itemization of applicable deliverables.   Have full awareness of the potential consequences of design and operating parameters to established robust and reproducible NORs and justified PARs
• Via external CMO, Lead Upstream cell culture process characterization and validation activities including; PHA, SDMQ, DOE or OFAT based Process Characterization, FMEA, and process validation activities.  Oversee all additional validation activities including LIVCA/EOPC, hold time studies, etc
• Partner with internal resources and external CMOs to drive process characterization and validation for one or more monoclonal antibody drug product program(s)
• Manage the execution of relevant development studies and documentation review for GBT drug candidates and commercial products, including authoring technical protocols and reports as applicable
• Lead author for applicable CMC modules in BLA submission
• Program owner for day to day production; make, assess, release activities of clinical and commercial production including MBR reviews, deviations, and change controls
• Company steward for obtaining the highest product quality including leading technical discussions and influencing stakeholder acceptance of critical process and quality-based decisions
• Responsible and accountable for monitoring process performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites

Essential Duties and Responsibilities:

• He/she carries out authentic, persuasive scientific/technical presentations of strategic nature in cross-functional environment and communicates effectively with senior management and external partners as well as demonstrates persuasive, authentic written communication skills with external partners or regulatory agencies
• Position requires strong scientific and practical knowledge of protein chemistry, biotherapeutics drug development, drug product manufacturing, regulatory documentation
• The ideal candidate should be able to lead cross-functional scientific/technical problem-solving efforts and applies lessons learned to develop systemic solutions
• Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs)
• Proficient in Stage 1, Stage 2, Stage 3 biologics validation including; PHA, CQA, CPP, KPI, DOE OFAT, PC, PV, PPQ
• Excellence in breadth and depth across engineering disciplines and is recognized as a subject matter expert for bio process development, characterization, and validation
• Significant experience and contribution to generation of relevant regulatory sections of BLA and MAA filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections
• Extensive experience with Upstream and Downstream operations from thaw through DS. DP experience a plus.  In-depth understanding of cell culture scale-up, engineering principles, and associated equipment – i.e. cell growth rates, nutrient consumption, gas transfers and velocities, titers and production rates
• General knowledge of the workstreams in the development of monoclonal antibodies; upstream and downstream processing preferred.  Formulation, drug substance and drug product development, molecule characterization, analytical development, and stability testing
• Strong individual contributor.  Must be able to work in a fast paced, multi-project and changing environment with ability to manage multiple competing responsibilities with a high degree of independence and self-motivation
• Outstanding written and verbal communication skills
• Strong organization and time management skills
• Team Player.  Ability to thrive in flat organizational structure with strong cross functional communications and contributions.  The team output is greater than the sum of the parts.  This Lean team depends on everyone working together for the common goals
• Partner with Cross functional teammates from Tech Ops, Analytical, Quality Assurance, Regulatory, and Clinical Operations

Qualifications:

• B.S./M.S./PhD. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related field with extensive experience in biotech or pharmaceuticals industry
  • 10+ years of relevant experience in the pharmaceutical industry and a BS or BA
  • 8+ years of relevant experience and a MS
  • 7+ years of relevant experience and a PhD in a relevant scientific discipline
• Relevant industry experience in development of monoclonal antibodies or biologics platform modalities (5-8 years). Position level will be commensurate with education level and previous industrial experience
• Biologics Process Engineering, MSAT, Technical Services SME
• Demonstrates excellent verbal, technical writing, and interpersonal communication skills
• Has proven analytical and conceptual skills
• Demonstrates ability to effectively manage multiple projects/priorities