Senior Process Engineer (Biologic Drug Substance / Technology Transfer)

Integrated Resources, Inc

Boston, MA

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JOB DETAILS

SALARY

$85–$89.65 Per Hour

SKILLS

Administrative Skills, Best Practices, Biochemistry, Biological Processes, Biology, Cell Cultures, Chemical Engineering, Chemistry, Chromatography, Cleanroom, Clinical Practices/Protocols, Clinical Support, Communication Skills, Continuous Improvement, Cross-Functional, Data Collection, Detail Oriented, Drug Development, GMP (Good Manufacturing Practices), Leadership, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Marketing Authorization Application (MAA), Materials Analysis, Materials Testing, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Engineering, Process Validation, Quality Assurance, Regulations, Regulatory Requirements, Regulatory Submissions, Risk Analysis, Standard Operating Procedures (SOP), Standards Development, Statistics, Team Player, Technical Presentation, Technical Support, Technical Writing, Willing to Travel, Writing Skills

LOCATION

Boston, MA

POSTED

15 days ago

$85-$89.65/hr

Title: Senior Process Engineer (Biologic Drug Substance / Technology Transfer)
Contract Length: 8 Months (non-extendable)
Location: Boston, MA 100% onsite preferred / Candidates from New Haven, CT may be considered if fully onsite
Industry Background: Pharma / Biotech preferred

Manufacturing environment experience is strongly preferred

Education & Experience Requirements
Bachelor s degree: 8+ years of relevant experience
Master s degree: 6 7 years of experience
PhD: 3 4 years of relevant experience acceptable

This is what you will do:
The Senior Process Engineer supports drug substance technology transfers across Client s biologics pipeline, spanning early phase, late phase, and commercialization within CClient. As a technical subject matter expert, this role partners with Process Development and Clinical Supply (PDCS), the internal non-GMP pilot network, Client Operations, Quality (QA), Regulatory (RA), and internal/external manufacturing sites to plan and execute transfer activities, ensure GMP-compliant manufacture, and drive process readiness.
The Senior Process Engineer develops standards, guidance, and tools to improve the effectiveness of technology transfers; serves as the technical SME and manages activities associated with GMP manufacturing and process validation; supports clinical and commercial regulatory submissions (e.g., IND/IMPD, BLA/MAA); and contributes to the development of robust raw material control strategies (including alternate material evaluations, specification justification, and risk assessments). Depending on business needs, the role may provide support across any or all these areas.

You will be responsible for:

" Support continuous improvement of efficiency of technology transfer processes through development of standard operating procedures, job aids, & supplemental reference/training materials and with alignment to ongoing digitalization initiatives.
" Work in partnership with Biologics Drug Substance leadership and SMEs to lead the development and implementation of robust raw material control strategy, inclusive of raw material assessments and justification of specifications.
" Serve as technical SME for routine activities for biologics tech transfer & GMP manufacture and validation including but not limited to creation/review of technical protocols or reports, manufacturing records, & quality records, sample plan coordination, and monitor & trend manufacturing batch performance.
" Support compilation of data for regulatory source documents & perform technical review of IND/IMPD, BLA/MAA for regulatory submissions.

You will need to have:
" A degree in related Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Biochemical, Mechanical) field. A PhD, a MS with at least 6 years of relevant experience, or a BS with at least 8 years of relevant experience.
" Experience and in-depth technical, and operational knowledge of multiple drug substance unit operations including cell culture, centrifugation, filtration, UF/DF, and chromatography.
" Comprehensive understanding clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure manufacturing operations are GMP compliant.
" This role is primarily office based, with requirement for routine on-site presence at the designated Client office. Ability to travel domestically up to two weeks (total on average ~25%) at a time for manufacturing site support.
During travel for manufacturing support, this role requires physical capabilities to gown and de-gown PPE in GMP cleanroom environment and be present during manufacturing operations in a technical support role. Physical elements include standing, climbing stairs, ladders, visual capability to read manufacturing control screens, use a computer, engage in communications via phone, video, and electronic messaging.
" Ability to drive for results independently and adapt to rapidly changing priorities.
" Effective problem solving and technical decision-making skills in a manufacturing environment.
" Strong oral and written communication skills and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners.
" Excellent collaboration skills, with ability to participate in global cross-functional teams and work effectively in a highly matrix team environment.
We would prefer for you to have:
" Prior experience in establishing and defending raw material control strategy and associated raw material specifications with regulatory agencies.
" Proven track record of supporting or leading continuous improvement initiatives.
" Knowledge and use of basic statistical analysis methods

About the Company

Integrated Resources, Inc

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