Senior Manufacturing Associate - 2ND SHIFT
$95,000–$122,500 year
On-siteFramingham, Massachusetts, United States
Job Summary
Execute cGMP manufacturing operations to support Replimune product production at the Framingham facility, including aseptic gowning, equipment cleaning, and single-use technology setup for viral production and filtration steps. Author Standard Operating Procedures, batch records, and change controls while performing visual inspection of final product vials and maintaining up-to-date training documentation. Collaborate with cross-functional teams to manage technology transfer, startup activities, and validation commissioning efforts, potentially working weekends or holidays as production needs dictate.
Required Qualifications
- Bachelor's degree and 3 to 6 years of related work experience in cGMP biopharma manufacturing
- Associate's degree or High School Diploma and 5 to 8 years of related work experience in cGMP biopharma manufacturing
- Minimum of 3 years working in positions in cGMP environment
- Experience working in two or more functional areas (Cell Culture, Purification of Drug Substance, or aseptic filling of Product)
- Experience with single-use manufacturing technologies
- Demonstrated ability to work in cross-functional teams across the business
- Strong organizational skills and attention to detail
- Excellent written and oral communication skills
- Ability to lift up to 50 pounds and stand for up to 3 hours at a time
- Must be experienced with Microsoft Word and Excel
- Must be available for weekend/holidays pending production
Desired Qualifications
- 3 to 6 years of related work experience in cGMP biopharma manufacturing
- 5 to 8 years of related work experience in cGMP biopharma manufacturing
- Experience working in two or more functional areas (Cell Culture, Purification of Drug Substance, or aseptic filling of Product)
- Experience with single-use manufacturing technologies
- Demonstrated ability to work in cross-functional teams across the business
- Strong organizational skills and attention to detail
- Excellent written and oral communication skills and strong team player
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.