FibroGen, Inc. is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in fibrosis and hypoxia-inducible factor (HIF) biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer.
FibroGen seeks an Bihoro http://hillaryaugustine.com/wordpress Associate Director & head of Late stage Downstream Antibody Manufacturing to support the manufacture and commercialization of Biologics Drug Substance at Contract Manufacturing Organizations (CMOs) in compliance with Good Manufacturing Practices (GMP). The successful candidate will form and oversee the Biologics Late Stage Downstream Manufacturing function at Fibrogen. This function is responsible for technology transfer, process characterization, scaleup and manufacturing oversight for late stage Downstream activities, with an emphasis on process performance qualification and establishment of commercial manufacturing. Downstream activities include harvest, protein purification, viral inactivation and buffer exchange steps.
- Process Development. This individual will engage in process development and lifecycle management activities for downstream operations particularly for antibody programs
- Technology Transfer to CMOs will be a critical component of the role, with responsibility on both Fibrogen to CMO and CMO to CMO transfers
- Scale-up activities for downstream drug substance at the CMO will carefully evaluated as part of this role
- This position will be responsible for providing technical oversight for downstream operations during GMP manufacturing runs
- Process Characterization. The successful candidate will oversee process characterization for downstream activities both at Fibrogen as well at as contract laboratories
- Process Performance Qualification technical oversight will be a key component of this role
- Represent manufacturing during CMO batch record review with Quality Assurance. Assist with the resolution of any deviations and facilitate the batch disposition process with Quality Assurance for downstream operations
- Develop and maintain metrics databases for tracking and trending manufacturing performance as appropriate
- Manage and provide input on Process Description updates and Change Control Requests related to equipment, process and facility changes at CMOs.
- Participate in GMP compliance audits of CMOs with FibroGen Quality Assurance.
- Masters or Ph.D. in engineering, chemistry, biology or other related scientific discipline.
- A minimum of 12 years experience in process development, process engineering and manufacturing environments post-Master's degree and 8 years post-Ph.D. degree
- Experience with monoclonal antibody downstream processing and purification processes including chromatography, filtration, viral inactivation and buffer exchange.
- Prior experience as the client of a CMO would be preferred
- Prior experience with Process Characterization, Process performance qualification and Commercial Manufacturing activities for a biologic product is strongly preferred.
- Demonstrated track record of success in a leadership role delivering manufacturing or operations results in a biopharma or pharmaceuticals environment.
- Experience with regulatory filings and section authorship is strongly preferred
- Working knowledge of US and EU cGMP regulations and guidelines.
- Effective interpersonal and communication abilities are desired.
- We are looking for strong writing skills including demonstrated track record of publications in the field
- Excellent team management skills, including taking initiative and accountability along with possessing high levels of self-direction.
- Approximately 15 to 20% travel as appropriate. Currently travel restrictions apply due to COVID-19
FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.
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FibroGen makes every effort to source and hire its staff through direct recruitment methods. Employment opportunities at FibroGen are managed by our internal human resources team. Please do not contact hiring managers or other FibroGen employees.
FibroGen does not accept unsolicited resumes from any source other than from the candidates themselves. FibroGen does not accept unsolicited communications from external recruiters. If there is a specific business need, a human resources team member will contact external recruiters directly.
An agency or independent recruiter must have a current, signed agreement and a work order for a specific position with FibroGen before presenting candidates and must be presented to human resources. Submission of unsolicited resumes without a signed agreement and an applicable work order will not create an obligation on the part of FibroGen to pay a fee of any kind.