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Sr Associate
Spectraforce
Matthews, North Carolina

3 months ago

Job Description

Sr Associate
12 months (potential extension)
Holly Springs, NC, 27540


Ideal Candidate:
Preferred is Masters degree or Bachelors degree with 2+ years of cGMP experience. 

Description:
As the candidate for this non laboratory-based position, you will be responsible for supporting technology transfer, process validation, and plant start-up.
You will work cross-functionally within "" North Carolina as you use process development experience to help drive efficient development and scalable understanding of processes. Collaborate with other site-functions and network drug substance teams in delivering plant goals.

*2+ years proven experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP).
*Knowledge in biologics purification processes.
*Experience in process scale-up, technology transfer and process validation.
*Able to apply engineering principles and statistical analysis in resolving complex issues.
*Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes.
*Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use).
*Familiarity with Process monitoring tools such as PI, SIMCA.
*Written and verbal communication skills will be important to help draft protocols, reports.
Demonstrate independence and ability to produce quality results under minimal direction. High energy individual who can multi-task and handle a fast-pace, dynamic work environment. Complete training on assigned tasks and comply with safety and compliance guidelines around process development activities.

Day to Day Responsibilities:
Be agile and work with process development team members to get tasks completed.
Support writing protocols, reports, data verification.
Process monitoring and escalating process issues

Basic Qualifications:
Master’s degree
OR Bachelor’s degree and 2 years of experience
OR Associate’s degree and 4 years of experience
OR High school diploma / GED and 6 years of experience

Top 3 Must Have Skill Sets:
Process Development Technology Transfer and cGMP experience
Multi-tasking and excellent communication and collaborative skills
Downstream or protein purification experience 

Applicant Notices & Disclaimers
  • For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $25.00/hr.

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