Contract – GMP QC Operations Manager

CONTRACT – GMP QC OPERATIONS MANAGER

Position Summary:

The GMP QC Operations Manager supports the analytical department for the GBT BLA development program of a monoclonal antibody.  Contributions to include Drug Substance and Drug Product stability program management as well as ownership of reference standard requalification and make/assess/release activities of a working reference standard.  Technical review and remediation of BLA enabling process characterization and method qualification/validation activities. The candidate will be responsible for timely initiating, maintaining and driving to closure all CMC related GMP documentations as required by GBT SOPs and regulatory guidance. The candidate will also be responsible to review and verify process and CMC analytical data from CMOs for critical GMP/regulatory documents. The candidate will also provide support to organize and archive the completed internal and external CMC documents. The candidate may perform other duties to support GBT biologics CMC development and operations as appropriate.

Essential Duties and Responsibilities:

• Mange GBT Stability Program for DS, DP, and Reference Standard by reviewing and assessing stability data from CMOs and authoring GBT Stability Reports
• Map and own sample shipment logistics for process characterization and validation
• Support project management activities for validation of analytical methods at CMOs for drug substance and drug product manufacturing
• Initiate Drug Substance and Drug Product analytical related deviations, Change Control and CAPAs per GBT SOP and drive the assessment process with GBT internal state holders to ensure the appropriate on-time closure
• Perform data review and the investigation of the analytical testing/validation issues
• Provide expert guidance on the large molecule analytical development, validation and establishment of specifications
• Support Quality, Regulatory Affairs in preparing CMC section in regulatory filings
• Review and assess reference standard data

Qualifications:

• A degree Biochemistry, Chemistry, Chemical engineering or related discipline. PhD with minimum 5 years of experience, MS with 10 years, BS with 15 years
• In-depth experience and knowledge in large molecule analytics
• Experience with reviewing analytical data for monoclonal antibody release testing and characterization (SEC, CGE, cIEF, potency, LCMS, wet chemistry methods, etc.)
• Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and comparability assessment
• Experience in recombinant protein submissions
• Must have excellent problem-solving skills and verbal and written communication skills
• Requires working knowledge of IND/BLA submissions, Quality and regulatory requirements
• Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
• Comfortable executing on multiple projects independently

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.