Large scale cell-culture or purification manufacturing Senior Process Engineer/Manager -
Manufacturing, Science & Technology (MSAT) is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. MSAT ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.
Summary of role:
- Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement
- Anticipate, respond to, and permanently resolve issues that arise during production.
- Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.
- Lead the creation and use of digital process data analytic systems.
- Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.
The Senior Process Engineer / Manager is expected to:
- Lead MSAT support to Thyrogen, Fz-ICB, and Falcon upstream commercial operations.
- Lead a group of experts/engineers that provide technical/scientific support, expertise, and guidance to manufacturing and quality.
- Support ongoing development of staff to maximize individual team performance.
- Utilize a solid understanding of scientific principles and professional practices to solve a range of complex problems in creative and practical ways.
- Provide input and coordinates support from process development teams. Coordinates with cross functional teams to progress lab studies.
- Reviews manufacturing processes and/or development and production data.
- Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.
- Provide CMC support and guidance for product lifecycle management.
- Attend development and scientific meetings to remain current with technology and regulatory guidelines. Interact with colleagues from various company functions in particular Engineering, Science, Manufacturing, Quality, and MSAT functions to meet the group’s goals.
- Bachelor’s Degree in engineering or science with 9 years of experience.
- Master’s degree in engineering or science with 7 years of experience.
- Ph.D. in engineering or science with 5 years of experience.
- Possess Leadership Qualifications, such as: Build, manage, motivate, and empower teams and workgroups. Take responsibility for developing one’s self and others in anticipation of future business needs.
- Experience with large scale cell culture or purification manufacturing.
- Experience leading technical teams and leading projects.
- Experience communicating with cross functional teams and senior management.
- Experience providing solutions for difficult technical issues.
- Strong technical writing skills.
- Experience with high level data analysis.
- Experience in biotechnology or the pharmaceutical industry.
- Experience with root cause analysis and/or risk assessment.
- Experience working with statistical analysis software.
Special Working Conditions:
- Occasional travel expected.
- Ability to lift weight.
- Ability to gown and gain entry to manufacturing areas.
Skills and Certifications [note: bold skills and certification are required]
large scale cell-culture or purification manufacturing
Experience in leading technical teams and projects
Base Salary - $90,000 to $130,000
Bonus Eligible - Yes
7+ to 10 years experience
Seniority Level - Mid-Senior
Management Experience Required - Yes
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Ideal Candidate, Meets all the Basic Qualifications as well as one of the Preferred qualifications, local and not in need of relocation assistance.