Senior Process Engineer Cell Culture/Purification

Redwood City, CA 94063

Posted: 03/25/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17328

Job Description


 

 

Senior Process Engineer Cell Culture/Purification

 

Description

 

The Process Engineer Cell Culture/Purification' s job is to evaluate, transfer and implement new processes into the GMP facility and to drive trouble shooting and continuous improvement activities/projects. Process/tech-transfers cover internal projects within BI, such as NBEs (New Biological Entities), Biosimilars, or external projects from clients (Contract Manufacturing Business) in early or late clinical phase as well as for launch and commercial supply. The position is responsible for planning and executing process transfers in a cross-functional project organization. This includes providing scientific and technological input as expert on site and within the global Biopharma.

 

You will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect high regard for our employees.

 

Duties & Responsibilities

 

• Process transfers

• Perform process/tech-transfer for assigned projects and supervise projects over time until commercial phase.

• Collaborate with other team members in cross-functional transfer teams, with international customers and lead of BI sub-teams.

• Responsible for performing the process evaluation and facility fit including materials, and identifying required equipment for new processes to be implemented in the GMP-manufacturing facility.

• Support Requests for Proposals from potential customers

• Perform scale-up with required adaptations and process improvements

• Plan process-transfer activities according to time line and quality

• Ensure optimal process design for maximal facility output to support competitiveness

• Manage technical interfaces with national and international clients and BI internal units (Process Science, Quality Assurance and Control, Supply Chain Management, Engineering and Technology, Project Management, Manufacturing, etc.).

• Be the single point-of-contact for respective technical clients

• Discuss and present results to internal or external customers to successfully transfer processes

• Design and planning of small-scale satellite studies in collaboration with Process Science during transfer-runs

• Plan back-up strategy for transfer campaigns

• Perform technical assessments

• Contribute to NPI and technical risk analysis

• Support filing documents, write and review sections within CMC dossiers

• Process monitoring /trending

• Monitor, analyze and evaluate process data and trends

• Closely collaborate with Process Science on internal improvement projects

• Create campaign/summary reports

• Trouble-shootings

• Conduct complex trouble shootings related to production (e.g., technical, equipment, and process performance issues, including planning of small-scale testing in collaboration with PS)

• Ensure that investigations are consistent with manufacturing practices (process and methods), policies and complying with external regulatory requirements.

• Manufacturing specific technology

• Provide input on how to maintain and improve plant technology

• Continuous improvement of business and manufacturing processes

• Introduction of new technologies for Cell Culture manufacturing

 

Requirements

• Mammalian Cell Culture/Purification Technology, Bioengineering Technology, Project Management, Good communication skills.

• Bachelors’ Degree with a focus in Biopharmaceuticals and/ Bioengineering and four (4) to six (6) years of professional experience or equivalent.

 

Desired Experience, Skills And Abilities

• Experience with cross functional teams

 

Eligibility Requirements

• Must be legally authorized to work in the United States without restriction.

• Must be willing to take a drug test and post-offer physical (if required)

• Must be 18 years of age or older

 

 

Meet Your Recruiter

Marissa Kochan

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