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Process development engineer [h1.location_city]

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Process development engineer • cambridge ma

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  • [promoted]
Senior Director, Process Development, Pharmaceutical Development

Senior Director, Process Development, Pharmaceutical Development

ElektrofiBoston, MA, United States
[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...[show_more][last_updated.last_updated_variable_days]
Scientist, Viral Vector Process Development

Scientist, Viral Vector Process Development

AsimovBoston, MA, US
[job_card.full_time]
Our mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology pla...[show_more][last_updated.last_updated_variable_days]
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Process Development, Director - Upstream (Biologics)

Process Development, Director - Upstream (Biologics)

The Association of Technology, Management and Applied EngineeringBoston, MA, United States
[job_card.full_time]
Vertex is seeking a highly skilled technical leader to join our Process Development / Engineering team to lead the design, development, optimization, and scale‑up of upstream processes to produce t...[show_more][last_updated.last_updated_variable_days]
Head, Biotherapeutics Process Development (BPD)

Head, Biotherapeutics Process Development (BPD)

Takeda PharmaceuticalsBoston, MA, US
[job_card.full_time]
Biotherapeutics Process Development Leader.As a member of the Pharmaceutical Sciences Leadership Team (PSLT) set the vision, strategy and direction for the global Biotherapeutics Process Developmen...[show_more][last_updated.last_updated_variable_days]
Engineer : Process Improvement Engineer

Engineer : Process Improvement Engineer

NanobiosymCambridge, MA, US
[job_card.full_time]
Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery.Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobio...[show_more][last_updated.last_updated_variable_days]
Director of Process Development

Director of Process Development

Germer International - Pharmaceutical RecruitingBoston, MA, US
[job_card.full_time]
Director of Process Development and Formulation.This position is responsible for leading and empowering the Development Team in taking Company’s’ drug product candidates from formulatio...[show_more][last_updated.last_updated_30]
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Director, Downstream Process Development - Biologics

Director, Downstream Process Development - Biologics

Vertex PharmaceuticalsBoston, MA, United States
[job_card.full_time]
Biologics, Cell and Gene Therapy is a rapidly growing part of Vertex Pharmaceuticals where research, development, and clinical manufacturing are highly integrated together at our new R&D site in Bo...[show_more][last_updated.last_updated_variable_days]
  • [promoted]
Head, Biotherapeutics Process Development (BPD)

Head, Biotherapeutics Process Development (BPD)

Takeda Pharmaceutical Company LtdBoston, MA, United States
[job_card.full_time]
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...[show_more][last_updated.last_updated_variable_days]
Process Engineer III

Process Engineer III

Vaxess TechnologiesWoburn, MA, US
[job_card.full_time]
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro- patch platform.With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature...[show_more][last_updated.last_updated_30]
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Director, Process Development

Director, Process Development

AlkermesWaltham, MA, United States
[job_card.full_time]
Position : Director, Process Development.An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development ...[show_more][last_updated.last_updated_variable_days]
  • [promoted]
Head, Biotherapeutics Process Development (BPD)

Head, Biotherapeutics Process Development (BPD)

Boston StaffingBoston, MA, US
[job_card.full_time]
Biotherapeutics Process Development Leadership.As a member of the Pharmaceutical Sciences Leadership Team (PSLT) set the vision, strategy and direction for the global Biotherapeutics Process Develo...[show_more][last_updated.last_updated_30]
Lead Process Engineer

Lead Process Engineer

Verdox, IncWoburn, MA, US
[job_card.full_time]
Verdox is dedicated to reversing climate change through the development and deployment of advanced technology.Our proprietary electro-swing process, developed at MIT, enables carbon dioxide and oth...[show_more][last_updated.last_updated_30]
Lead Engineer I, Pharmaceutical Development, Process Development

Lead Engineer I, Pharmaceutical Development, Process Development

Elektrofi IncBoston, MA, US
[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...[show_more][last_updated.last_updated_30]
Scientist II, Upstream Process Development

Scientist II, Upstream Process Development

GenezenLexington, MA, US
[job_card.full_time]
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients.We provide process development, produce GMP viral vectors, and provide cell transduction f...[show_more][last_updated.last_updated_30]
Drug Substance Process Development Scientist

Drug Substance Process Development Scientist

Eurofins USA PSS Insourcing SolutionsBoston, MA, US
[job_card.full_time]
The work we do at Eurofins matters, and so do our employees.At Eurofins, we put a focus on your professional growth.We provide our employees the ability to break into the biopharmaceutical industry...[show_more][last_updated.last_updated_variable_days]
Head, Biotherapeutics Process Development (BPD)

Head, Biotherapeutics Process Development (BPD)

TakedaBoston, Massachusetts, United States
[job_card.full_time]
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...[show_more][last_updated.last_updated_30]
Oligonucleotide Scientist I, Process Development

Oligonucleotide Scientist I, Process Development

Editas MedicineCambridge, MA, US
[job_card.full_time]
At Editas Medicine, we are pioneering the possible.Our mission and commitment is to translate the power and potential of the CRISPR / Cas12a and CRISPR / Cas9 genome editing systems into a robust pipel...[show_more][last_updated.last_updated_variable_days]
Director, Downstream Process Development - Biologics

Director, Downstream Process Development - Biologics

VertexBoston, MA, US
[job_card.full_time]
Biologics, Cell And Gene Therapy Technical Leader.Biologics, Cell and Gene Therapy is a rapidly growing part of Vertex Pharmaceuticals where research, development, and clinical manufacturing are hi...[show_more][last_updated.last_updated_variable_days]
Senior Process Engineer

Senior Process Engineer

WerfenBedford, MA, United States
[job_card.full_time]
Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States.Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specia...[show_more][last_updated.last_updated_variable_days]
Senior Director, Process Development, Pharmaceutical Development

Senior Director, Process Development, Pharmaceutical Development

ElektrofiBoston, MA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_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 biologics, we partner with companies to develop and commercialize our novel Hypercon™ formulations. 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 Senior Director, Process Development to support the development of the novel Hypercon™ formulation platform. This individual is accountable for leading the Process Development function within our Pharmaceutical Development team. The successful candidate will be responsible for developing, scaling up, and technical transfer of ultra-high concentration protein microparticle suspension drug products and advance of manufacturing platforms and product candidates from formulation feasibility studies into clinical and commercial manufacturing.

KEY RESPONSIBILITIES

  • Lead and grow a nimble and high-performing Process Development team, responsible for defining and implementing the clinical and commercial manufacturing strategy for novel protein microparticle suspension-based products
  • Provide strategic, technical and scientific leadership to the Process Development team and to cross-functional program and initiative teams
  • Build cutting-edge process development capabilities that emphasize aseptic operations and deliver the desired physical characteristics of protein microparticles while preserving the biological properties of the active substance
  • Maintain knowledge of current best practices of bioprocess and aseptic manufacturing. Identify emerging trends and technologies and lead implementation / feasibility assessment, as appropriate.
  • Guide the execution of process development, scale-up, characterization, manufacturing trouble-shooting, and phase-appropriate validation activities, as well as the transfer of processes to internal labs and external CDMOs
  • Collaborate and communicate effectively with external corporate partners and internal stakeholders across the Technical Development team with groups including Drug Product Innovation, Formulation Development, Analytical Development, Quality, and Translational Development
  • Author, review and approve technical documents, including but not limited to study protocols, process development and validation reports, batch records and process / manufacturing sections of regulatory documents
  • Maintain and grow process development lab space and capabilities and oversee process development budget across our multiple programs
  • Actively participate in preparation of domestic and international regulatory filings in collaboration with internal and external stakeholders.
  • Foster the growth and development of process development staff
  • Represent the company externally at meetings (professional associations, with regulatory bodies, etc.)

Requirements

MINIMUM QUALIFICATIONS

  • Ph.D. or Master's degree in Biological, Pharmaceutical, or Chemical Engineering, Chemistry, Biochemistry or related discipline
  • Minimum of 12 years (15 years with a MS) of relevant process development experience, including a minimum of 5 years in a managerial capacity
  • Extensive experience in manufacturing lifecycle management, including process development, scale-up, and technology transfer in support of IND, clinical and / or commercial activities in the biotech or pharmaceutical industry.
  • Prior experience in drug substance or drug product process development for biotherapeutics, with an established track record of translating lab-based processes to a clinical manufacturing setting toward commercialization. Experience with microparticle production and characterization is highly desirable.
  • Experience developing and implementing GMP aseptic drug product filling processes highly desirable
  • Demonstrated leadership skills, including the ability to manage a scientific team, communicate, coach, mentor and develop employees
  • Strong scientific reasoning, problem-solving and engineering skills, including knowledge and practical experience implementing relevant technologies / unit operations toward the scale-up of aseptic protein microparticle suspensions.
  • Deep expertise with monoclonal antibodies, proteins, and / or vaccines.
  • Excellent interpersonal, organizational, negotiation and communication (verbal and written) skills are essential.
  • Ability to think, plan, and influence strategically on the process development priorities across multiple projects is necessary.
  • Must be a leader willing to be both a "coach and a player".
  • Willingness to travel domestically and internationally as needed
  • Expertise with platform process design, scalability principles, and QbD methodologies
  • Strong communication skills and comfort working with internal stakeholders and external partners.
  • Experienced with the regulatory expectations for biotherapeutic and aseptic manufacturing

    • 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

    Salary Description

    $240,000-$275,000