Talent.com
Senior Engineer II, Pharmaceutical Development, Process Development

Senior Engineer II, Pharmaceutical Development, Process Development

Elektrofi IncBoston, MA, US
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Job Description

Job Description

Description : ABOUT ELEKTROFI

Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously administered biologic therapies by enabling convenient at-home subcutaneous self-administration. With a focus on monoclonal antibodies, therapeutic proteins, and other large molecule drugs, we create, develop, and commercialize subcutaneous biologic therapies in collaboration with strategic partners. We believe a patient-centered healthcare approach can lead to a healthier world. We are headquartered in Boston and innovate globally. We are Formulating the Future of Biologics ™.

POSITION SUMMARY

Elektrofi is seeking a motivated individual to join our biotech company as a Sr. Engineer II to support the development of our novel Hypercon™ formulation platform. This individual will lead and support the technical execution of platform process development activities across a diverse portfolio of partner programs. As Sr. Engineer II you will contribute deep technical expertise across one or more unit operations, ensure scalability of platform processes, and serve as a critical link between development, manufacturing, and external partners. This role is ideal for an experienced engineer ready to lead cross-functional efforts, mentor junior staff, and drive platform adaptability to meet evolving program needs. The individual will join a growing, multidisciplinary team of scientists / engineers and industry professionals.

Key Responsibilities

  • Design and execute platform and program process development studies including mixing, TFF, sterile filtration, and filling.
  • Serve as a technical lead on development workstreams supporting platform improvement and tech transfer to GMP manufacturing site.
  • Analyze data, identify trends, and define critical process parameters and critical quality attributes.
  • Author and review technical documentation including protocols and reports to support CMC regulatory submissions.
  • Interface with Manufacturing Sciences & Technology (MSAT), QA, Analytical, and partner-facing teams to align technical deliverables.
  • Mentor junior engineers and contribute to the growth of technical and operational best practices.
  • Support continuous improvement of the platform to enhance scalability, robustness, and program flexibility.
  • Identify and follow through on opportunities for innovation and continuous improvement in the drug product manufacturing process, and lead initiatives aimed at improving process knowledge and scale-up strategies.
  • Provide direct management oversight of 1-2 technical personnel.
  • Ability to travel up to 10% to support international Tech Transfer to CMO.

Requirements :

MINIMUM QUALIFICATIONS

  • B.S. in Chemical, Biomedical, Materials, or Pharmaceutical Engineering, or a related engineering discipline w / 8+ years of relevant experience in process development or biomanufacturing, or M.S. w / 6+ years or Ph.D. w / 2+ years of relevant experience.
  • Demonstrated ability to lead process development and cross-functional projects.
  • Proven technical and strategic leadership in cross-functional teams and ability to communicate with stakeholders and partners.
  • Experience with cGxP and aseptic manufacturing is required .
  • Experience with novel platform development is preferred .
  • Experience developing biologic drug products or parenteral suspensions is preferred.
  • Experience in processes involving ATEX, Class I Div I, Class I Div II equipment design is a plus .
  • Experience with single-use systems (SUS), filtration technologies, Downstream biologic DS purification, Aseptic Drug Product manufacturing, Fill / Finish or CIP / SIP.
  • Familiarity with platform process design, scalability principles, and QbD methodologies.
  • Strong communication skills and comfort working with internal stakeholders and external partners.
  • Proficiency with data analysis and visualization tools (e.g., JMP, Excel, Minitab).
  • Our unique strength lies in transforming pioneering ideas into concrete, life-transforming solutions. To realize this ambitious vision, we are dedicated to nurturing an in-office work ethos. While remote work has its merits, it does not constitute a fundamental aspect of our working approach. Please apply at elektrofi.com / careers.

    EEOC Statement :

    Elektrofi provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

    To all agencies, please, no phone calls or emails to any employee of Elektrofi about this requisition. All resumes submitted by search firms / employment agencies to any employee at Elektrofi via email, the internet, or in any form and method will be deemed the sole property of Elektrofi unless such search firms / employment agencies were engaged by Elektrofi for this requisition and a valid agreement with Elektrofi is in place. If a candidate submitted outside of the Elektrofi agency engagement process is hired, no fee or payment of any kind will be paid.

    All candidates must be legally authorized to work in the US.

    #LI-Onsite

    serp_jobs.job_alerts.create_a_job

    Development Engineer Ii • Boston, MA, US

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Clinical Testing Psychologist (PhD, PsyD)- (Child and Adolescent) - Greenbush, MA

    Clinical Testing Psychologist (PhD, PsyD)- (Child and Adolescent) - Greenbush, MA

    LifeStance HealthGreenbush, MA, US
    serp_jobs.job_card.full_time
    At LifeStance Health, we believe in a truly healthy society where mental and physical healthcare are unified to make lives better. Our mission is to help people lead healthier, more fulfilling lives...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Process Engineer II

    Senior Process Engineer II

    Lancesoft INCDanvers, MA, US
    serp_jobs.job_card.full_time
    Be a part of a dynamic team that designs and develops manufacturing processes for new delivery systems from concept through design transfer and product launch. This process development team is commi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Process Engineer

    Senior Process Engineer

    Rochester Electronics LNewburyport, MA, US
    serp_jobs.job_card.full_time
    Rochester Electronics is immediately hiring for a Senior Process Engineer!.At Rochester Electronics, we create an excellent employee experience focused on value, performance, motivation, recognitio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Process Engineer

    Senior Process Engineer

    CyberCodersBoston, MA, US
    serp_jobs.job_card.full_time
    Hybrid in New Canaan, CT - Up to 50% Travel a month.We were founded in 2014 and starting to expand.Our HQ is in Ireland and have manufacturing running in the United States.We are extracting protein...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Director : Head of Upstream Process Development

    Senior Director : Head of Upstream Process Development

    EPM ScientificBoston, MA, US
    serp_jobs.job_card.full_time
    Job Title : Senior Scientist / Engineer - Process Development & Upstream Manufacturing.Bio process Development / Manufacturing Sciences. Director of Process Development or Head of Manufacturing.We ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    2.1. Senior Process Engineer

    2.1. Senior Process Engineer

    Phoenix TailingsBurlington, Massachusetts, United States, 01803
    serp_jobs.job_card.full_time
    Phoenix Tailings is a rapidly-growing clean mining and metals production startup dedicated to sustainable and economic critical metals production. Our mission is to be the world's first fully clean ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Engineer, Device Development

    Senior Engineer, Device Development

    Vaxess TechnologiesWoburn, MA, US
    serp_jobs.job_card.full_time
    Vaxess is an NIH and venture-funded company developing a pipeline of next-generation therapeutics on the Microneedle Patch (MAP) platform. With only five minutes of wear-time on the skin, the self-...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Director, Drug Product Development

    Senior Director, Drug Product Development

    Scholar RockCambridge, MA, US
    serp_jobs.job_card.full_time
    Senior Director, Drug Product Development.Scholar Rock is seeking a highly experienced and technically strong Senior Director of Drug Product Development to lead formulation and drug product develo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director, Downstream Process Development (Boston)

    Associate Director, Downstream Process Development (Boston)

    EPM ScientificBoston, MA, US
    serp_jobs.job_card.part_time
    We are proud to be partnering with a leading biopharmaceutical organization on an exciting search for an Associate Director of Downstream Process Development. This individual will oversee a team of ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Process Engineer III / IV- Small Molecule / Oligo / Peptide

    Process Engineer III / IV- Small Molecule / Oligo / Peptide

    CRBBoston, MA, US
    serp_jobs.job_card.full_time
    CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Director, Process Chemistry

    Senior Director, Process Chemistry

    Ardelyx, Inc.Waltham, MA, United States
    serp_jobs.job_card.full_time
    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medic...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Manager, Specialized Chemical Development

    Senior Manager, Specialized Chemical Development

    Deciphera PharmaceuticalsWaltham, MA, US
    serp_jobs.job_card.full_time
    Manager, Specialized Chemical Development will support assigned process chemistry activities for drug substance (DS), DS intermediates and starting materials. The initial main focus for this positio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Director, Process Chemistry

    Senior Director, Process Chemistry

    ArdelyxWaltham, MA, United States
    serp_jobs.job_card.full_time
    Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medic...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Director, Process Development, Pharmaceutical Development

    Senior Director, Process Development, Pharmaceutical Development

    Elektrofi IncBoston, MA, US
    serp_jobs.job_card.full_time
    Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines.Our breakthrough ultra-hi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Process Engineer

    Senior Process Engineer

    ATR InternationalDanvers, MA, US
    serp_jobs.job_card.temporary
    Hybrid in Danvers, MA (4 days onsite weekly).Large client in medical devices industry.Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining e...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    2.4. Chemical Development Engineer II

    2.4. Chemical Development Engineer II

    Phoenix TailingsBurlington, Massachusetts, United States, 01803
    serp_jobs.job_card.full_time
    Chemical Development Engineer II.Phoenix Tailings is a rapidly growing clean mining and metals production startup dedicated to sustainable and economic critical metals production.Our mission is to ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Engineer II, R&D and New Product Development

    Engineer II, R&D and New Product Development

    EntegrisBillerica, MA, United States
    serp_jobs.job_card.full_time
    Engineer II, R&D and New Product Development.Entegris is looking to meet a talented individual who will lead with ideas to solve critical separation problems in new ways. This individual will play a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Associate Director, Downstream Process Development

    Associate Director, Downstream Process Development

    EPM ScientificBoston, MA, US
    serp_jobs.job_card.full_time
    We are proud to be partnering with a leading biopharmaceutical organization on an exciting search for an Associate Director of Downstream Process Development. This individual will oversee a team of ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30