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Manufacturing Technician- Internal Manufacturing

2 months ago

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

ABOUT ELEKTROFI

Elektrofi is a biopharmaceutical formulation technology company that 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. Formulating the Future of Biologics. www.Elektrofi.com.


POSITION SUMMARY

Elektrofi is seeking a talented, enthusiastic, and experienced Manufacturing Technician who will be responsible for operating lab and pilot plant scale unit operations at Elektrofi. This role reports to the Manager, Technical Operations and will support the manufacturing of biologically active microparticle suspensions and their interactions with delivery devices. This individual will join a growing, multidisciplinary team of scientists/engineers to contribute to a variety of manufacturing activities in a highly collaborative environment.


This role will work on technology transfer projects to introduce new drug substances to the pilot plant process. Support Elektrofi pilot plant unit operations to provide robust manufacturing procedures used to process monoclonal antibody drug substance and drug product for IND enabling studies. Assist in continued process improvement and optimization. Advance automation and digital capabilities as part of the IT strategic roadmap. Serve as the interface between Manufacturing, Laboratory Operations, Supply Chain, Quality, Process Development, and Analytical Development for work conducted on the manufacturing floor. Perform as needed materials receipt, handling, and transportation for laboratory operations and pilot plant production. Participate in Tier shift exchange meetings to communicate on safety, quality, delivery, cost, and engagement. Serve on cross-functional business teams to successfully accomplish goals and objectives, while continuously improving manufacturing performance. Report on key performance indicators (KPIs) to measure and trend manufacturing performance. The Manufacturing Technician role should thrive in a fast-paced, dynamic environment and be a key player in the company’s growth.


KEY RESPONSIBILITIES

Essential duties and responsibilities include the following. Other duties may be assigned.

  • Perform all duties in keeping with the company’s core values, policies, and applicable regulations.
  • As a member of the Technical Operations Team, be a change leader to develop and implement innovative approaches to meet the challenges of a rapidly growing business.
  • Accountable for executing manufacturing batch records to manufacture materials for IND enabling studies.
  • Closely partner with Laboratory Operations, Supply Chain, Safety, Process Development, Analytical Development, and Quality.
  • Cleaning and sanitizing of manufacturing equipment.
  • Operations with flammable solvents and pressurized manufacturing equipment.
  • Operation of balances for material transfers.
  • Manufacture of buffers for processing.
  • Operation of computer systems for drug product manufacture.
  • Storing and transfer of finished drug product to internal customers.
  • Adhere to cGXP requirements while maintaining sufficient agility to adapt to dynamic and evolving business needs.
  • Ensure training and qualification are maintained to deliver safe, right-first-time execution.
Requirements:

MINIMUM QUALIFICATIONS

  • High school diploma with minimum of 2 years working in the biotech/pharmaceutical industry in manufacturing required.
  • Two-year technical program certificate or degree preferred.
  • Preferred experience in manufacturing operations for aseptic bulk processes making biopharmaceuticals.
  • Knowledge of current Good Lab/Manufacturing Practices (cGLP/cGMP).
  • Strong verbal and written communication skills in English.
  • Ability to follow and document written SOPs and batch records accurately and legibly.
  • Ability to do basic math calculations contained in manufacturing batch records.
  • Basic experience with traditional biopharma lab equipment (centrifuges, peristaltic pumps, pipettes, etc).
  • The ability to work independently and efficiently once tasks are delegated.
  • Familiarity with computer programming languages and standard office software (MS Office).
  • Good attention to detail and the ability to thoroughly document deviations from procedures.
  • Prior experience with solvent processing and/or monoclonal antibody processing as plus.
  • Ability to work independently and as part of a team.
  • Basic computer skills.

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.


EOC 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.

The candidate must be authorized to work in the US.