Lead Cell Processing Specialist

THIS ROLE WILL REQUIRE MARYLAND RELOCATION

Permanent Full-Time Position

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Lead BioProcess Associate

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Our team at PharmAllies has teamed up with a mid-sized biopharma manufacturing firm to supply them with the personnel (Full-Time Permanent Positions) needed for critical COVID vaccine manufacturing efforts. This company, on the forefront of producing lifesaving vaccines, values the diversity each employee brings to their role and their contributions to helping them achieve their mission?to protect and enhance life. They also value talent, develop employees and offer opportunities to advance their staff so that they can achieve personal and professional growth. If you want to make a worldwide health impact, take a look at our available positions and apply today!

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JOB SUMMARY

The Lead Bioprocess Associate position reports to Supervisor/Manager Manufacturing. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. The Lead BPA is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Operates pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
• Demonstrates, understands and adheres to company policies, GMP standards and safety procedures
• Troubleshoot, advanced maintenance and repair activities on equipment and systems used in Manufacturing according to Standard Operating Procedures (SOPs)
• Perform and monitor critical processes, execute routine validation protocols, work orders
• Informs supervisor/ manager on progress of projects, transfer of data, process details, etc.
• Executes batch records according to GMP and site quality standards
• Generates Batch Records, SOPs and Protocols as required
• Responds to off-hour alarms as assigned by supervisor/ manager
• Executes manufacturing cleanroom changeover and activation
• Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
• Supports QA during audits and regulatory inspections
• Supports other manufacturing process teams and other company groups as necessary to achieve Manufacturing team goals

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• HS diploma with 7 or more years’ experience with production processes under GMP compliance
• OR Associate degree in a Scientific, Engineering or Biotech field with 5 years’ experience with or biologic production processes under GMP compliance OR
• Bachelor’s degree in a Scientific, Engineering or Biotech field with 2-3 years’ experience with biologic production processes under GMP compliance
• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
• Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

• There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job.
• This information is available upon request from the candidate.
• Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Job Type: Full-time

Pay: $0.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift

Experience:

• Cell culture: 3 years (Preferred)

Work Location:

• One location

Company's website:

• www.PharmAllies.com

Work Remotely:

• No

COVID-19 Precaution(s):

• Remote interview process
• Social distancing guidelines in place