JOB SUMMARYThe Senior BioProcess Engineer will provide technical leadership on major development-, manufacturing-, and tech transfer-related projects. The incumbent will plan, coordinate, communicate, and summarize projects. The incumbent should have solid education, technical and organizational leadership, and proven development and CGMP experience to support MS&T mission, i.e., to ensure that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved.
ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
The MSAT department at the Canton site of Emergent BioSolutions ensures that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved. Our core responsibilities include:
- Enable reliable supply of vaccines and therapeutics by providing direct scientific and technical leadership to commercial manufacturing operations.
- Anticipate, respond to, and permanently resolve manufacturing issues to safeguard our right to operate and supply.
- Support new processes, equipment, facility design, and other life-cycle activities to improve quality, efficiency, capacity, and economics.
Business- Work independently with little to no supervision. Exercise considerable latitude in determining technical objectives/approaches to major assignments.
- System owner responsibilities for multiple focus areas within the MS&T function, e.g., Process Monitoring, Process Validation, Technology Transfer, Continued Process Verification, etc.
- Maintain good working relationships with internal and external partners/customers, i.e., Manufacturing, QA, QC, Regulatory, Engineering, Supply Chain, EHS, etc.
- Guides the successful completion of major programs and may function in a project leadership role.
- Participate on MS&T Leadership Team to ensure appropriate alignment of resources to technical challenges and routine operational needs.
Technical- Provide fast-paced campaign support for manufacturing during technical production issues or escalations.
- Represent MS&T as the prime technical contact on contracts and projects.
- Work with manufacturing teams to provide technical support to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes.
- Support existing business processes such as reviewing and approving MFG SOP/FRM/BPR document revisions, deviations, CAPAs, CCRs.
- Develop and maintain structure for process data reviews for internal and external production.
- Develop and draft study plans and protocols as required to support process changes, deviation responses, and regulatory requirements, etc.
- Lead process investigations and drive process improvement initiatives.
- Review technical documents authored by the other team members.
- Evaluate and develop advanced technological ideas and summarize their development into final reports.
Scientific- Designs experiments for the development of cell lines and optimization of cell line production processes; analyzes the data from such experiments and participates in the formulation of conclusions and next steps.
- Serves as lead for tech transfer of cell culture and purification processes to internal departments.
- Develops and maintains cell lines and cell banks
- Writes and executes experimental protocols for developing/optimizing processes for potential use in manufacturing.
- Trouble-shoots and maintains cell culture and purification systems.
- Trains other members of the team in techniques.
- Safely handle serum and/or tissues from preclinical studies as well as samples of human origin.
- Safely handles BSL-2 reporter viruses and tissue samples under a BSC.
People Management/Employee Development- Supervise daily activities for Intern/Co-op students and contractors to ensure safety and effectiveness
- Assist Manager in bringing new staff up to speed. Train new employees or junior staff on hands-on skills
- Mentor junior staff on technical and operational skills
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
MINIMUM EDUCATION, EXPERIENCE, SKILLS- BS, MS, or PhD in Science or Engineering with a minimum of (BS+8yrs) /(MS+6yrs)/ (PhD+4yrs) of relevant job experience in biopharma or pharmaceutical industry
- The Senior BioProcess Engineer should have solid technical leadership in several functional areas and in-depth CGMP experience with vaccines/biologics manufacturing science and technology.
- Experience working under a Quality Management System.
- Ability to manage multiple priorities and tasks in a dynamic environment. Ability to make sound scientific decisions regarding compliance-related issues with minimal supervision and guidance.
- Work effectively in a team environment and have a high level of personal accountability and responsibility.
- Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
- Understanding of MS&T activities including but not limited to: Technology Transfer Strategy and Implementation; Process Development, Product Process Improvement, QbD / PAT; Process Characterization and Control; Process validation
- Comprehensive technical knowledge with a strong science-and-risk based mindset
- An understanding of scientific methods, statistical analysis, and standard lab notebook format.
- Robust technical and communication skills: oral/written and listening
- Proficient in Microsoft Office and statistical and productivity software, i.e., JMP/MiniTab or equivalent, Visio, MS Project, etc.
Preferred Qualifications- Good organization skills; high-level personal accountability and responsibility; proven planning, organization, and multitasking skills
- Stay abreast of emerging technology, digital transformation, and industry trends
- Direct experience in tech transfer, engineering, quality, and regulatory
- Expertise with all aspects of project management skills, including planning, tracking, adhering to budget/schedule and communicating, etc.
- Good understanding of drug product processes
- Hands-on experience with high throughput bioreactor systems.
- Capable of searching scientific literature to gain information about specific topics.
U.S. Base Pay Ranges and Benefits Information
The estimated annual base salary as a new hire for this position ranges from $129,000 - $156,000. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]
Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent
(*Eligibility for benefits is governed by the applicable plan documents and policies).
If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
