Reports to: Senior Director, CMC

Location: Remote Work, US Only

Position Summary: 

 The Senior Manager, Drug Substance CMC (Upstream/Cell Culture) provides comprehensive technical support and expertise in Chemistry, Manufacturing, and Controls (CMC), particularly focusing on process development, characterization, manufacturing, and tech transfer of the cell culture/upstream portion of the Drug Substance process. The role primarily involves leadership of technical aspects of the cell culture/upstream process while ensuring compliance with regulatory standards and meeting objectives and requirements for internal and external funders and stakeholders. Additionally, responsibilities include supporting furthering cAd3-Marburg Vaccine and cAd3-Sudan Vaccine development and commercialization activities, including compiling documentation needed for future funding initiatives. 

Responsibilities:

• Provide technical leadership of all aspects of upstream drug substance manufacturing and process development including starting materials such as cell banks and viral seeds
• Support process characterization and optimization efforts to support commercial control strategy development at partner CMOs
• Author technical reports and protocols
• Assist with the writing and reviewing documents for INDs / regulatory section submissions
• Prepare, review, or edit validation, CMC, Regulatory, and Quality documents such as risk assessments and E&L, microbial control, viral control, and process control strategy documents
• Perform statistical analysis of manufacturing process data, identification and investigation of adverse trends
• Lead technical investigation teams to identify root causes of process and analytical deviations
• Working closely with project managers at both Internal Sites and CDMO's to ensure project milestones are maintained
• Collect information and prepare documentation to support future funding efforts
• Manage, create and review CMC and Quality Systems documentation as required
• Support tech transfers to other facilities

• Minimum bachelor’s degree in chemical or pharmaceutical engineering, chemistry, biochemistry, analytical chemistry, or a related engineering or pharmaceutical science field. Advanced degree highly desired.
• Minimum of 10 years of direct experience with CMC aspects of biopharmaceutical manufacturing and development, including substantial recent experience in upstream  manufacturing and process development
• Direct experience and training in current good manufacturing practices (cGMP)
• Working knowledge of ICH guidelines and associated regional requirements (FDA, EMEA, MHRA and similar), particularly with the ICH Q5-series, Q8, Q9, Q11 and Q12.
• Non-conformance investigation and root cause analysis
• Corrective/preventive action implementation
• Demonstrated ability to work in a collaborative team environment across multiple technical functions and geographical regions
• Ability to work independently with minimal direct oversight
• Position may require up to 15% travel, within the USA and Europe, to support start-up, oversight and person-in-plant duties at identified CDMOs.

Preferences:

• Experience with management of CDMOs and tech transfer
• Experience with regulatory agency interactions and/or responses to information requests
• Experience with HEK293 cell culture and infection-based manufacturing processes
• Knowledge of adenoviral vector manufacturing processes or process development
• Strong statistical background, including six sigma principles and tools, SPC, and DoE methodologies
• Experience with process validation design and execution
• Experience with commercialization of late stage (Phase 3) biopharmaceutical products, including Drug Product process characterization and BLA/MAA authoring and defense

Other:

• Must demonstrate interest in furthering Sabin’s mission
• Subject to a criminal background investigation 
• Request for three professional references
• Verification of education/degrees

Sabin’s philosophy is to ensure fair, unbiased, equitable, and competitive compensation and benefits. Using benchmarking and salary survey data, the starting annual salary for this position ranges from $115,000 - $155,000. The exact compensation may vary based on skills, experience, training, certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs. 

Sabin offers a competitive benefits package that includes Medical, Dental, Vision and Flexible Spending Accounts. Employer paid, Life and Disability insurance along with 11 paid holidays with a winter break between Christmas and New Years. Employer match on 401(k).

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.