Sr BioProcess Engineer, MS&T

Emergent BioSolutions; Canton (MA); On-site; USD 129,000 - 156,000; Full time

Job summary

Emergent BioSolutions in Canton, MA is seeking a Senior BioProcess Engineer to provide technical leadership on development, manufacturing, and tech transfer projects. You will plan, coordinate, communicate, and summarize initiatives to ensure processes are capable, compliant, in control, cost-effective, and continuously improved.

The role requires solid CGMP experience, strong leadership across MSAT functional areas, and ability to manage multiple priorities in a dynamic manufacturing

Qualifications

• 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.
• 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; make sound scientific decisions with minimal supervision.

Responsibilities

• Provide technical leadership on development, manufacturing, and tech transfer projects.
• Coordinate, communicate, and summarize projects; ensure processes are capable, compliant, and in control.
• Lead campaigns and provide fast-paced support during production issues or escalations.
• Lead tech transfer for cell culture and purification processes and review/approve deviations, CAPAs, and data reviews.

Skills

Technical leadership

Statistical analysis

Oral/written communication

Team collaboration

Education

BS/MS/PhD in Science or Engineering

Tools

JMP/MiniTab

Visio

MS Project

Microsoft Office

Job description

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Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world. Here, you will join passionate professionals where our culture is informed
by our values and commitment to protecting and saving lives.

JOB SUMMARY

The 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 FUNCTIONS

Reasonable 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

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

• 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.
• 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.]

(*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.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Emergent prepares those entrusted with protecting their communities against current and future health threats.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • We are engaged and accountable for delivering on our commitments.
• Breakthrough thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.