Manufacturing Associate II

## Manufacturing Associate IIApply:
Norwood, Massachusetts:
Drug Manufacturing:
Full time:
Posted Today:
R19755
*
* The Role:

** This
** Manufacturing Associate II, DP Operations
** builds on core cGMP experience, performing routine unit operations—including formulation, filtration, aseptic filling within isolators, and downstream visual inspection. This role ensures material and component readiness, performs enhanced in-process controls, and keeps equipment within defined parameters while documenting contemporaneously in MES/e . The associate works under moderate supervision and contributes to operational efficiency through adherence to SOPs, collaboration across functions, and active participation in a clean and compliant manufacturing environment.

Success is measured by plan attainment, documentation accuracy, right-first-time execution, and effective knowledge sharing.
** Here’s What You’ll Be Doing:
*** Perform formulation, sterile filtration, vial/syringe filling, and visual inspection in accordance with SOP’s and cGMP requirements.
* Conduct equipment checks, material staging, aseptic line clearances, and routine facility/equipment cleaning using approved disinfectants.
* Complete accurate, contemporaneous, and compliant ALCOA+ documentation, including logbooks and electronic batch record (e ) entries.
* Perform required in-process checks, accurately record results, and ensure compliance with established specifications and procedures.
* Identify and promptly escalate deviations, atypical events, and equipment issues; support troubleshooting and investigations by providing relevant data and statements.
* Support the development and revision of SOPs and work instructions and implement continuous improvement opportunities.
* Maintain strict adherence to cGMP, gowning, aseptic behavior, safety, and documentation requirements while maintaining a clean and safe operating environment.
* Complete required training, maintain qualifications and skills matrices, and train/mentor peers to support team capability and compliance.
* Collaborate effectively with QA, QC, MS&T, Facilities, Supply Chain, and other cross-functional partners during routine operations and issue resolution.
* Work effectively in a fast-paced, cross-functional manufacturing environment, demonstrating flexibility to support cross-training, operational coverage, off-hours, and overtime as needed.
** Here’s What You’ll Need (Basic Qualifications):
*** Associates or Bachelors Degree in a Scientific field or a High School Diploma with equivalent experience.
* 2-4 years in GMP manufacturing or similar environment preferred; we will train strong entry-level candidates.
* Comfortable working in clean rooms with full gowning and standing for extended periods; able to lift up to ~35 lbs.
* Basic computer skills (batch records, training systems).
* Must have 20/20 vision (corrected vision allowed – i.e., glasses, contact lens) and maintain the ability to see all colors across the visible spectrum.  A vision test will be required upon hiring to confirm vision acuity and will be administered annually thereafter.
* Reliable, detail-oriented, follows instructions, communicates clearly, and works well on a team.
* ** This position requires availability to work a 12-hour night shift from 6:00 PM to 6:00 AM**, including flexibility to support operational coverage, cross-training, overtime, weekends, and holidays as business needs require.
** Our Working Model
** As we build our company, we have always believed that an in-person culture is critical to our success.

This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.

Working onsite…