Senior Director of Process Development

2 months ago

Boston, United States Elektrofi Inc Full time
Job DescriptionJob DescriptionDescription:

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 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 BiologicsTM.


POSITION SUMMARY

Elektrofi is seeking a motivated individual to join our biotech company as a SENIOR DIRECTOR OF PROCESS DEVELOPMENT to support the development of the novel Elektrofi platform. This role 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 our HyperconTM (hyper concentration) microparticle suspension products, and advancing our manufacturing platforms and product candidates from formulation feasibility studies into clinical and commercial manufacturing. This role will be joining and leading a growing, multidisciplinary team of scientists/engineers and industry professionals, so candidates enthusiastic about coaching and supporting this growth are encouraged to apply.


KEY RESPONSIBILITIES

  • Lead and grow a nimble and high-performing Process Development team, responsible for defining and implementing the manufacturing lifecycle strategy for novel protein microparticle suspension-based products
  • Provide strategic, technical, and scientific leadership to the Process Development team
  • Optimize and implement clinical manufacturing processes for novel protein microparticle suspension-based products
  • Build innovative 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 drug delivery. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate
  • Guide the execution of process development, scale-up, characterization, manufacturing troubleshooting, and phase-appropriate validation activities, as well as the transfer of processes to internal labs and external CDMOs
  • 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
  • Design, build and resource process development lab space and oversee process development budget across our multiple programs
  • Actively participate in preparation of domestic and international regulatory filings in collaboration with Regulatory and Quality
  • 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
  • Foster the growth and development of process development staff
  • Provide technical leadership of cross-functional Program or initiative teams
  • Represent the company externally at meetings (professional associations, with regulatory bodies, etc.)
Requirements:

MINIMUM QUALIFICATIONS

  • Ph.D. or Master’s degree in Biological or Chemical Engineering, Molecular or Cellular Biology, Biochemistry or related discipline
  • Minimum of 12 years (min. 15 years with Master’s) 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 record of translating research processes to a clinical manufacturing setting toward commercialization. Experience with microparticle production and characterization is highly desirable
  • Knowledge of relevant regulatory requirements for the development and clinical implementation of biotherapeutic manufacturing processes and aseptic processing of biologics
  • Experience developing and implementing GMP drug product filling process 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
  • Demonstrated analytical and critical thinking skills
  • Deep expertise with monoclonal antibodies, proteins, and/or vaccines
  • Excellent interpersonal, organizational, negotiation and communication (verbal and written) skills are essential
  • The 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”
  • Ability and willingness to travel domestically and internationally as needed

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. As part of our commitment to enhancing the in-office experience, we provide all employees with a commuter assistance program, offering support of up to $315 per month. 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 United State

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