Associate, Manufacturing Operations

Abeona Therapeutics Inc.•Cleveland, OH

9d•$63,000 - $65,000•Onsite

About The Position

Join Abeona Therapeutics as a Manufacturing Associate I, Operations and be a part of a mission-driven organization devoted to putting patients first. In this role, you will play a crucial part in ensuring that our cutting-edge health care solutions meet the highest quality standards. Collaborate with talented individuals dedicated to transforming lives through innovative therapies. Work onsite Sunday to Wednesday (10-hour shifts) during and contribute to impactful products that change peoples' lives. With a competitive salary of $63,000 to $65,000 per year (with an annual discretionary bonus in addition to base salary), this position not only offers financial rewards, but also the opportunity to build your career in a supportive, collaborative, and values-focused environment. You will have options to participate in a comprehensive benefits program that includes options for Medical insurance to meet various individual/family needs, company covered basic Dental and Vision insurance (with additional coverage options), HSA and FSA options, a Lifestyle Spending Account, 401k options (with a company match program), and up to 160 hours of Paid Time Off per calendar year. Oh, and snacks! We have healthy snacks and beverages, as well as a few good, old-fashioned sweets, so that you can keep those energy levels up throughout the day. As a Manufacturing Associate I, Operations at Abeona Therapeutics, your day-to-day activities will focus on manufacturing initiatives supporting multiple product pipelines. The candidate will be an integral part of a fast-paced group responsible for the manufacture of retroviral vector, autologous gene-corrected cell therapies, and clinical AAV gene therapies. Responsibilities will include executing protocols and manufacturing clinical material across multiple products as well as supporting process optimization work and document generation. The ideal candidate will have experience in production of biologics in a controlled cGXP setting. Strong aseptic and cell culture technique as well as collaborative work in a team is an integral part of this position. Your expertise will directly impact the quality and reliability of our therapeutic solutions, all while upholding our commitment to putting patients first. This position enables you to contribute meaningfully to the advancement of gene-based therapy solutions in a compliance-focused environment.

Requirements

BS or equivalent in scientific discipline and min of 2-4 years related lab experience or MS or equivalent with 1-2 years of experience.
General biological lab experience (GxP experience strongly preferred).
Experience with mammalian and/or insect cell culture technology.
Experience with production processes for cell therapies and/or viral vectors or vaccines is highly preferred.
A strong background in the fundamentals and scale-up of production of biologic molecules strongly preferred.
Familiarity with aseptic technique, cell culture, and cell counters is strongly preferred.
Advanced communication and organizational skills.
Advanced interpersonal skills and the ability to work with individuals across all organizational levels.
Attention to detail and accuracy.
Detailed record keeping and data documentation.
Demonstrated project management skills.
Ability to read, analyze, and interpret technical procedures, publications, intellectual property and/or government documents.
Working knowledge of GLP, GDP, GCP and GMP regulations and their ISO counterparts and ICH Guidelines.
High level of proficiency with Microsoft Office programs.

Nice To Haves

Experience in production of biologics in a controlled cGXP setting.
Strong aseptic and cell culture technique.
Collaborative work in a team.

Responsibilities

Produce cell therapies in cGMP facility in conjunction with manufacturing production records (MPRs).
Execute studies in support of process optimization and validation.
Author, review, and provide technical support for manufacturing SOPs and MPRs.
Identify, suggest, and manage projects in parallel with manufacturing activities to reach set goals.
Ability to collaborate with others while maintaining a strong capability in independent, critical thought.
Strong organizational skills required.
Must be able to work as part of a team.
Contribute to activities that support safety and/or lab infrastructure.