Contract - MSAT/CMC Biologics Drug Product Lead

CONTRACT - MSAT/CMC BIOLOGICS DRUG PRODUCT LEAD

Position Summary:

This role is responsible for managing all aspects of the Phase III drug product development and production of a monoclonal antibody program.  This role will have ownership of Manufacturing, and validation activities of a biologic product at the CDMOs; serving as a technical subject matter and site manager. This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory, supporting the corporate objectives through BLA approval and commercial launch. 

Essential Duties and Responsibilities:

• Oversee GMP production, material assessment and GMP release of Parenteral Drug Product material at external Contract Manufacturing organization
• Design and execute Stage 1-2 validation at Contract Manufacturing Facility, providing input and owning Validation Master Plan and other relevant internal documents
• Review and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, and validation protocols/reports
• Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections
• Prepare CMC sections of regulatory submissions
• Expert knowledge in filling development and validation for parenteral, technology transfer procedures, and cleanroom requirements

Qualifications:

• Local or remote position with domestic travel as applicable (up to 25%) for right candidate
• B.S. degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or other related discipline. M.S. degree preferred. Equivalent combination of education and applicable job experience may be considered
• 8 years of relevant experience including biologics drug product manufacturing, scale-up, and late-stage drug development
• Demonstrated hands on experience with parenteral DP manufacturing at external CMO including technical transfers and process validation deliverables
• Technical, MSAT, engineering background a plus
• Self-motivated with strong interpersonal and organizational skills and excellent verbal and written communication skills are required
• Strong communication skills and emotional intelligence to communicate and interact internally and with external contractors to drive program deliverables
• Knowledge of cGMP with a detailed understanding of all stages of Process Validation lifecycle in biologics with Process Design, PPQ, and Continued Process Verification (CPV)

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.