Job details
Job type full-time
Full job description
Title: associate director/director, process engineering
Reports to: senior director, process engineering
Location: redwood city, california
Classification: exempt
Overview:
The associate director/director, process engineering will be responsible for process development, process transfer, troubleshooting manufacturing issues, scaling up biopharmaceutical manufacturing processes, process characterization and process & equipment validation activitiesThe associate director/director 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:
Support the transfer and scale up of the drug substance manufacturing processes.
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
Provide technical oversight of routine drug substance manufacturing including, but not limited to, batch data analysis, change control assessment, and deviation resolution.
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 drug development risk management processes.
Travel as required to manufacturing sites located in the united states
Experience, education, training, traits:
Bs degree in chemical / manufacturing engineering or equivalent experienceMs/phd is preferred
Minimum 10+ 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 domestically, approximately 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 dateThis 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 remoteIf 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.
Job type: full-time
Work location: multiple locations
