Associate II, Manufacturing
$65,000–$74,984 year
On-siteHarmans, Maryland, United States
Job Summary
Complete Batch Production Records under current Good Manufacturing Practices and generate operational protocols including Standard Operating Procedures and deviation reports. Collaborate with Process Development and Manufacturing Sciences teams to transfer new projects into GMP and troubleshoot process or equipment issues. Support initiation and closure of deviations, lead departmental investigations, and recommend equipment purchases for production areas. Work closely with production management to develop techniques that meet objectives and avoid delays while assisting other teams as needed. Interact with clients during manufacturing campaigns and participate in facility expansion and equipment validation activities. Maintain full training in all GMP manufacturing operations while adhering to safety guidelines. Night shift, 7pm-7am on a 2-2-3 rotation. 100% Onsite at Harmans, MD.
Required Qualifications
- High School diploma or General Education Diploma with 4+ years of experience in upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
- Associate's degree in a Scientific, Engineering, or Biotech field with 2+ years of experience in upstream or downstream biologic production processes under GMP compliance
- Bachelor's degree in a Scientific, Engineering, or Biotech field with 1+ years of experience in upstream or downstream biologic production processes under GMP compliance
- Strong knowledge and ability to apply scientific principles to solve operational and routine production tasks
- Excellent documentation skills including comprehension, review, and establishing Batch Production Records, Standard Operating Procedures, deviations, and summary reports
- Team-oriented with the ability to collaborate effectively across Manufacturing, Quality Control, Quality Assurance, Regulatory, and Materials Management functions
- Strong written and verbal communication skills with proficiency in English
- Ability to work flexible schedules, including shift, overtime, and weekend coverage as required by production needs
- Capable of performing physical requirements of the role, including lifting up to 40 pounds and extended periods of standing, walking, bending, reaching, pushing, and pulling
- Ability to work safely and effectively in a manufacturing environment while maintaining a strong focus on quality, compliance, and operational excellence
- Night shift, 7pm-7am on a 2-2-3 rotation
- Location: Harmans, MD - BWI 100% Onsite
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