Azaaki Solutions

Title: BMA Upstream

BMA I Pay Rate $25.50

BMA II Pay Rate $28.50
Location: Rockville MD 20850

Duration: 4+Months

Description:

Initial shift schedule (core hours) is 8:00 am - 4:30 pm w/ 30 min unpaid lunch Monday through Friday
OT and weekend work may become required
there is a possibility of extension or conversion at end of 6 months

Position Summary:

The Biomanufacturing Associate II plays an integral role within CRL’s gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles, processes, procedures, inputs, and outputs, for designated production processes and handovers within a regulated environment to ensure the timely production and release of quality products, based on client specifications.

Key Responsibilities and Duties:

• Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements.
• Effectively execute a range of tasks, in line with SOPs, in the following area:
• • Upstream Activities (e.g., solutions, media aliquot, and buffer preparation and autoclave materials for cell culture, staging of raw materials, seed train, bioreactor set up, fermentation monitoring and/or harvest).
• Follow instructions when performing planned manufacturing activities, in alignment with the batch record.
• Prepare, edit, and complete quality documents. Well-versed in applying GDP.
• Ensure data integrity - accurately document and review work prior to submission.
• Document, record, investigate, and report observed process variances/deviations, in real time.
• Follow instructions when operating equipment. Prepare, clean, and maintain equipment/tools.

Title: BMA Downstream

Location: Rockville MD 20850

Duration: 4+Months

Pay Rate $31.50/hr.

Qualifications:

• HS Diploma/equivalent and 6 years of related experience, A.S. with 5 years, or a B.S. in biology/life sciences, bioengineering, or related discipline with 3 years of related experience.
• Prior cell/gene therapy experience in a highly technical role, covering a wide range of tasks, within a cGMP/biotech manufacturing environment or related industry/role.
• Informal coaching or project management experience is desirable.
• Qualified as a LEAN trainer or willing to become qualified.

 Pay Rate $23.5/hr.

Initial shift schedule (core hours) is 8:00 am - 4:30 pm w/ 30 min unpaid lunch Monday through Friday
OT and weekend work may become required
there is a possibility of extension or conversion at end of 6 months

Preferred Qualifications for the role

? High School Diploma or Associate Degree with 0-2 years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company; or

? Bachelor of Science in science or Engineering and 0-1 years of experience in Downstream biologic production processes in a GMP environment in a Life Sciences Company

? Basic knowledge and understanding of purification processes

? Ability to obtain sufficient hands-on experience with chromatography systems (AKTA systems at different scales) and approaches (Affinity, IEX, MMC), TFF modalities, and single use mixing systems

? Ability to learn to operate manual and semi-automated equipment in support of routine production with supervision? Experience in the preparation of buffers