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Principal Engineer
Boulder, CO
Job Description
Position Description
This Manufacturing Sciences and Technology (MS&T) Principal Engineer position will lead a team responsible for process development, and process transfer for clinical and commercial manufacturing. This person and their team will also have responsibilities for the ownership of processing equipment and unit operations, including system design, procurement, installation, and support. Additional job functions include:
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
This Manufacturing Sciences and Technology (MS&T) Principal Engineer position will lead a team responsible for process development, and process transfer for clinical and commercial manufacturing. This person and their team will also have responsibilities for the ownership of processing equipment and unit operations, including system design, procurement, installation, and support. Additional job functions include:
- Providing process development and process engineering direction for multiple products, including cross-product platforming and standardization strategies. Applying advanced engineering principles to develop industry approaches for new or existing technologies and leverages these approaches to expand KBI business opportunities.
- The ability to use negotiation skills drive to resolution on critical issues. The ability to summarize complex issues and present to executive management.
- The ability to manage and/or apply extensive technical expertise to resolve complex problems across multiple projects or programs. Qualified candidates will be industry experts in at least one area of process technology. A strong aptitude to make decisions and recommendations that form the basis for corporate decisions that can impact the reputation and business performance of the company.
- This role will lead efforts of organization across functional boundaries. This role is expected to manage staff and project leads in matrixed organizational model. The Principal Engineer will be responsible as the primary technical contact for client projects.
- PhD in engineering with a minimum of 10 years of relevant experience, MS in engineering with a minimum of 12 years of experience, or bachelor’s degree in engineering with a minimum of 15 years of relevant experience.
- Extensive expertise in upstream or downstream processing techniques and unit operations and equipment in biologics is required.
- Extensive expertise in technology transfer, scale up, and equipment design is required. Qualified candidates will have an awareness of and experience with new technologies and process development approaches to debottleneck manufacturing operations.
- Knowledge of industry best practices, guidelines, and regulations related to process validation (PDA/ICH/BPOG) and boards of health (FDA/ICH/EMA) is strongly preferred
- Experience with GMP compliance and experience working in a cGMP manufacturing environment is required.
- Knowledge of process development and experience supporting IND development and early phase GMP production
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
Job Summary
Company
Employment Term and Type
Regular, Full Time
Hours per Week
40
Salary and Benefits
135,000 - 165,000 p/yr
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.
Required Education
Master's Degree
Required Experience
10+ years
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