Manufacturing Associate

Posted on May 3, 2022 by Hemogenyx Pharmaceuticals LLC

New York, NY 10022
Research
Immediate Start
Hourly Salary
Full-Time
Job Description

About Hemogenyx Pharmaceuticals, LLC

Hemogenyx Pharmaceuticals LLC is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune diseases. The Company is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development.

Role Description

Hemogenyx Pharmaceuticals is seeking a cell therapy manufacturing associate with a strong background in biology to support its cell therapy program towards in-human clinical studies to treat blood malignancies. The manufacturing associate will process primary human cells to generate cell therapy products under GMP compliance. The successful candidate will independently execute manufacturing process runs and document procedures and results by complying with all standard operating procedures and policies. He/she will prepare reports and present study results at team meetings. He/she will work cross-functionally across research and development, and manufacturing teams in order to successfully utilize key research findings towards development and refinement of manufacturing process for high quality drug product. Excellent interpersonal and communication skills are essential for the success of our company.

Responsibilities
• Perform cell processing operations utilizing various cell manufacturing devices (such as Lovo, Rotea, Cytiva, Prodigy, Cocoon, or other manual operations) to prepare products for adoptive immunotherapies. Processes include but not limited to: thawing biological samples, positive and negative cell isolation, cell preparation from a variety of sources [bone marrow, peripheral blood, umbilical cord blood and various tissues], cell culture and expansion, cryopreservation, and quality control testing.
• Implement existing manufacturing protocols and identify important process improvement areas.
• Follow SOPs on equipment use, maintenance procedures.
• Develop and prepare batch records and perform database and cell processing entry.
• Prepare and assemble all documentation (SOPs, protocols, batch records and other forms) for practice production runs, process qualification runs and clinical manufacturing runs.
• Perform in vitro cell culture assays on cell products.
• Drive project timelines for various cell manufacturing runs to meet critical deadlines.
• Work cross-functionally across multiple programs to provide technical support and expertise across pre-clinical, development, manufacturing and clinical groups.
• Contribute towards the preparation of documents for regulatory submission.
• Assist inventory management and coordinate timely delivery of raw materials for manufacturing runs.
• Manage and perform shipping operations for incoming materials, outgoing samples for testing, and outgoing final product.
• Monitor quality control for processes and equipment utilized for manufacturing cell therapy products.
• Complies with all standard operating procedures and lab and facility policies.
• Takes action quickly to resolve any issues during manufacturing by consulting with a supervisor.
• Perform other tasks as assigned.
• Perform all responsibilities with emphasis on requirements for GMP compliance.
Job Requirements

Qualifications

• Bachelor's or Master's degree in life sciences, chemistry, biology, pharmacy, engineering or related fields with 1-2 years relevant experience in a manufacturing environment preferred.
• Basic knowledge of aseptic techniques.
• Experience in operating laboratory instruments such as centrifuges, cell washers, cell separators, flow cytometers, microscopes, and liquid nitrogen controlled rate freezers.
• Knowledge and experience in operating cell/biologics manufacturing devices is a plus.
• Basic knowledge of cGxP regulations.
• Ability to work weekends when needed to perform on-going manufacturing runs.
• Basic knowledge of inventory management to ensure smooth workflow.
• Outstanding interpersonal and communication skills.
• Strong collaborative and teamwork skills.
• High level of self-motivation, entrepreneurial spirit, and ability to thrive in a fast-paced, goal- and team-oriented biotechnology startup environment.

Please forward your CV and cover letter to (Attn: Dr. Vladislav Sandler)

Equal Employment Opportunity & Employment Eligibility

Hemogenyx Pharmaceuticals is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Hemogenyx Pharmaceuticals also complies with all applicable national, state and local laws governing nondiscrimination in employment, as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Must be legally eligible to work in the United States without sponsorship.
Please don't forget to mention Bio Careers when applying.

Reference: 1584495723

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