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Manager Aseptic Processing Jobs in Boston, MA (NOW HIRING)

DPS Group

Process Engineer

Framingham, MA · On-site

... aseptic processing, cell therapy products and process development * Ability to think critically ... Project and Program Management, Procurement, Design, Construction Management, Health and Safety ...

LeMaitre

Sr. Engineer, Quality - Allografts

Burlington, MA · On-site

$96K - $130K/yr

Completes product and process validation, re-validation work which includes equipment and aseptic ... Manages and improves assigned areas within the Quality Management System (QMS) including SOPs, work ...

LeMaitre

Sr. Engineer, Quality - Allografts

Burlington, MA · On-site

$130K - $140K/yr

Completes product and process validation, re-validation work which includes equipment and aseptic ... Manages and improves assigned areas within the Quality Management System (QMS) including SOPs, work ...

LeMaitre

Sr. Engineer, Quality - Allografts

Burlington, MA · On-site

$130K - $140K/yr

Completes product and process validation, re-validation work which includes equipment and aseptic ... Manages and improves assigned areas within the Quality Management System (QMS) including SOPs, work ...

RoslinCT US

Cell Processing Associate I

Hopkinton, MA · On-site

Activities include aseptic sampling of product in a Biosafety Cabinet (BSC) in an ISO V environment ... or Manager What You Will Bring: * A highly organized work style that ensures timely execution of ...

Organogenesis

Production Associate I

Canton, MA · On-site

$24.04/hr

... aseptic processing of a living product; the production of ICL and FortaFlex Products; or activities associated with HTP Product under the direct supervision the Manager. This role will support the ...

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Manager Aseptic Processing information

What is a manager aseptic processing?

A Manager of Aseptic Processing oversees the sterile production environments in pharmaceutical or biotechnology manufacturing. They are responsible for ensuring that products are processed and packaged without contamination, following strict regulatory and safety standards. Their role includes supervising staff, maintaining compliance with Good Manufacturing Practices (GMP), conducting risk assessments, and implementing process improvements. They also play a key part in training employees and managing documentation to ensure product quality and patient safety.

What are the key skills and qualifications needed to thrive as a manager aseptic processing?

To thrive as a Manager Aseptic Processing, you need a strong background in microbiology, pharmaceutical manufacturing, quality assurance, and regulatory compliance, often supported by a relevant degree and experience in sterile production environments. Familiarity with Good Manufacturing Practices (GMP), cleanroom management systems, and environmental monitoring tools is essential. Leadership, attention to detail, and effective communication are crucial soft skills for managing teams and ensuring strict adherence to protocols. These skills and qualities are vital to maintain product sterility, meet regulatory standards, and ensure patient safety in pharmaceutical operations.

What are some common challenges faced by a manager aseptic processing, and how can they be addressed?

Managers in Aseptic Processing often face challenges related to ensuring strict compliance with regulatory standards, maintaining a contamination-free environment, and leading cross-functional teams in high-pressure situations. Addressing these challenges requires staying updated on evolving industry guidelines, fostering a culture of continuous training, and implementing robust monitoring systems. Effective communication and collaboration with Quality Assurance, Maintenance, and Production teams are also crucial for swiftly resolving issues and upholding product safety.

What is the difference between Manager Aseptic Processing vs Aseptic Processing Technician?

AspectManager Aseptic ProcessingAseptic Processing Technician
CredentialsBachelor's degree in life sciences or related field, GMP training, leadership experienceHigh school diploma or associate degree, GMP training
Work EnvironmentSupervisory role overseeing aseptic processes in pharmaceutical manufacturingHands-on role operating aseptic equipment in cleanroom settings
ResponsibilitiesManaging teams, ensuring compliance, process optimizationPerforming aseptic procedures, equipment setup, documentation

The Manager Aseptic Processing oversees the aseptic manufacturing process, focusing on team management and compliance, while the Aseptic Processing Technician handles the direct operation of aseptic equipment. Both roles require GMP training and work in sterile environments, but the manager has additional leadership and oversight responsibilities.

What job categories do people searching Manager Aseptic Processing jobs in Boston, MA look for?

The top searched job categories for Manager Aseptic Processing jobs in Boston, MA are:

What cities near Boston, MA are hiring for Manager Aseptic Processing jobs?

Cities near Boston, MA with the most Manager Aseptic Processing job openings:

Manager Aseptic Processing jobs near you

Manager, Quality Assurance (RLT Manufacturing Ops)

Mariana Oncology

Watertown, MA • On-site

$85K - $158K/yr

Full-time

Re-posted 9 days ago

Job description

Reporting:
Associate Director, Quality Assurance
Description:
We are seeking an experienced Manager, QA, RLT Manufacturing Operations, to join Mariana's Quality Assurance organization, advancing personalized medicine and radiopharmaceuticals. The QA Manager for Radioligand Therapy GMP Manufacturing Operations plays a critical role in ensuring that radiopharmaceutical products are manufactured, tested, and released in full compliance with cGMP, radiation safety regulations, and applicable global quality standards. This position provides QA oversight to daily operations, supports batch review and release, manages deviations and CAPAs, and partners closely with manufacturing, QC, manufacturing sciences & technology, and radiological safety teams to maintain a robust, inspection-ready quality culture.
Illustrative Breadth of Responsibilities:
  • Leadership and Training
    • Lead the QA RLT Operations team.
    • Coach and develop QA RLT Operations team members, fostering a culture of quality, accountability, collaboration, and continuous improvement.
    • Serve as a subject matter expert (SME) in radiopharmaceutical GMP requirements, aseptic operations, and radiation-handling quality considerations.
    • Train manufacturing and QC personnel on quality systems, deviations, and compliance standards.
    • Support GMP training program by creating and delivering Operations QA training modules.
  • GMP Operations Oversight
    • Lead QA support for radioligand manufacturing, including aseptic processing, sterile filtration, radiolabeling, and final product packaging.
    • Perform line clearances, room/equipment release, and real-time production record review.
    • Provide quality oversight for product lifecycle activities, technology transfer, process qualification and validation activities, process changes, and new product introductions.
    • Review technology transfer, process validation, manufacturing process risk analysis, product stability, and other types of technical reports to support IND and global regulatory submissions.
    • Serve as a key quality representative in cross functional governance forums and escalation processes.
    • Ensure adherence to GMP, ALCOA+ data integrity principles, and radiation safety requirements.
  • Batch Record Review & Product Release
    • Draft and approve master production records.
    • Review executed batch records, analytical data, specifications, protocols, reports, logbooks, and supporting documentation for radiopharmaceutical intermediates, drug products, and finished products.
    • Disposition raw materials, components, and finished radioligand batches.
  • Quality Systems Management
    • Review, approve, and drive timely resolution of quality events, including investigations related to deviations, OOS/OOT results, and complaints.
    • Review and Approve CAPAs, change controls, and risk assessments.
    • Maintain GMP documentation and controlled forms. Draft QA Operations SOPs. Review and approve quality assurance, manufacturing, and quality control procedures.
  • Inspection and Audit Readiness
    • Prepare for and support internal audits, regulatory inspections (e.g., FDA, EMA, ICH), and corporate quality assessments.
    • Ensure manufacturing areas remain in a state of compliance and inspection readiness.
  • Continuous Improvement
    • Identify and drive improvements in processes, documentation, and compliance across radioligand operations.
    • Support implementation of new equipment, facility upgrades, and process changes.
    • Identify systemic issues and lead initiatives to improve right first-time performance, compliance, and operational efficiency.
    • Promote a strong quality and safety culture with emphasis on radiological safety and GMP rigor.

Requirements/Skills:
  • Position is a hybrid role with 4 days a week attendance required in the Watertown manufacturing facility to perform onsite QA activities related to cGMP manufacturing and quality control testing.
  • Bachelor's or Master's degree in relevant scientific or engineering discipline with at least ten years of experience working within Quality Assurance in the pharmaceutical or biotechnology industry. Experience working with radiopharmaceuticals and/or oncology will be considered as a plus.
  • Experience with working in and implementing a global QMS adhering to EU GMP Vol 4 Part I, IV, and applicable EU GMP Annexes (including but not limited to Annex 1 and Annex 3), 21 CFR 210-212, 21CFR Part 11, ICH, and USP requirements.
  • Experience supporting aseptic operations, isotopes/radioligands, or PET/SPECT radiopharmaceutical environments preferred.
  • Ability to work collaboratively with cross functional teams including manufacturing, quality control, supply chain, technical development, and facilities personnel.
  • Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.

Mariana Oncology's Principles
  • Building a Legacy
  • Execution Excellence
  • Courage of our Convictions

Mariana Oncology Compensation Summary:
The salary for this position is expected to range between $85,400 and $158,600 per year. Your compensation will also include a performance-based cash incentive.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and will be reviewed periodically upon joining Mariana Oncology. Mariana may change the published salary range based on company and market factors.

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