Title: Manager/Senior Manager, Manufacturing Sciences
Reports To: Vice President, Manufacturing Operations and Engineering
Location: Redwood City, California
The Manager/Senior Manager, Manufacturing Sciences will be responsible for technical support of commercial Drug Substance (DS) manufacturing processes. The Manager/Senior Manager will support, troubleshooting manufacturing issues (investigation/deviation resolution), process lifecycle initiatives, laboratory oversights, and process & equipment validation activities. The Manager/Senior Manager will also support routine drug substance manufacturing at Contract Manufacturing Organizations through batch data analysis, change control assessments, and deviation/investigation resolution.
Principle Responsibilities and Duties:
- Provide technical oversight of routine drug substance manufacturing including, but not limited to, batch data analysis, change control assessment, and investigation deviation resolution.
- Assist in the development of manufacturing documentation such as process descriptions, batch records and SOPs.
- Support feasibility assessments of additional manufacturing projects and partners for capabilities such as automation, equipment, GMP facility, process enhancement, and general requirements for scale-up and manufacturing
- Work in collaboration with manufacturing partners to define process requirements to meet production needs
- Use design of experiments techniques and basic statistical methods to analyze data and communicate results, conclusions, and recommendations.
- Monitor and communicate task status for project/program success.
- Participate in product and process FMEAs and related risk management processes.
- Potential travel to manufacturing sites
Experience, Education, Training, Traits:
- BS degree in Chemical / Manufacturing Engineering or equivalent experience. MS/PhD is preferred.
- Minimum 5+ years of experience in biotech/pharmaceutical industry required.
- Experience working with Contract Manufacturing Organizations (CMOs)
- Experience in process development and scale up through process validation and technology transfer including CMC preparation for regulatory filings
- Experience in support of routine drug substance manufacturing
- Detailed knowledge of cGMP requirements and application
- Proven ability to work collaboratively with all levels to meet project deliverables
- Must operate with a high degree of autonomy and professionalism
- Must be innovative, technical, resourceful and well organized
- Must communicate in a timely and accurate manner to ensure project participants are fully informed of project status, action items and deliverables
- Demonstrated ability to be flexible and maintain a professional attitude when priorities change
- Demonstrated ability to work in a fast paced, start-up environment
- Ability to travel up to 25%.
- Excellent interpersonal and communication skills.
- Strong computer skills, including all MS Office applications and MS Project
Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.