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Manager Aseptic Processing Jobs in Massachusetts

Ajinomoto Cambrooke, Inc.

Production Manager

Ayer, MA · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Aseptic processing experience a plus. Previous experience implementing Lean Manufacturing principles, continuous improvement, employee involvement, and change management initiatives and processes.

Ajinomoto Cambrooke, Inc.

Production Manager

Ayer, MA · On-site

$116K - $135K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... processes. • Aseptic processing experience a plus. • Previous experience implementing Lean Manufacturing principles, continuous improvement, employee involvement, and change management ...

RoslinCT US

Cell Processing Associate I

Hopkinton, MA · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

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 ...

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All JobsAseptic Processing JobsManager Aseptic Processing JobsManager Aseptic Processing Jobs in Massachusetts

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 are popular job titles related to Manager Aseptic Processing jobs in Massachusetts?

For Manager Aseptic Processing jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Manager Aseptic Processing jobs in Massachusetts look for?

The top searched job categories for Manager Aseptic Processing jobs in Massachusetts are:

What cities in Massachusetts are hiring for Manager Aseptic Processing jobs?

Cities in Massachusetts with the most Manager Aseptic Processing job openings:

Manager Aseptic Processing jobs near you

Senior Scientist, Upstream Process Development

Stylus Medicine

Cambridge, MA • On-site

$155K - $170K/yr

Full-time

Re-posted 12 days ago

Job description

About Stylus Medicine:
Stylus Medicine is developing transformative in vivo genetic medicines to unlock cures. Stylus combines engineered recombinases with non-viral delivery to specifically encode therapeutics. The company's approach is versatile and modular, with potential therapeutic application across oncology, autoimmune, genetic diseases, and beyond.
About the Role:
Stylus Medicine is seeking an intellectually curious and collaborative Senior Scientist, who will lead the development of upstream microbial fermentation processes as part of our CMC Tech Ops team. This role will be responsible for process definition, development, characterization, scale-up and tech transfer from bench scale to pilot. Working closely with the Research, Preclinical, and Formulation teams, this is a special opportunity to advance the development of transformative in vivo genetic medicines.
Key Responsibilities & Accountabilities:
  • Develop scalable production processes for nucleic acids and recombinant proteins
  • Leverage expertise in fermentation and mammalian cell culture to design, optimize, scale-up and characterize production processes
  • Independently utilize multivariate design of experiment (DoE) approaches to improve productivity and optimize parameters for product quality
  • Drive fermentation platform development and new technology implementation to improve process performance, generation of predictive process models, and enhance process control and robustness
  • Design and implement in-process analytics to improve productivity while reducing process and product derived impurities
  • Maintain and troubleshoot equipment to ensure consistency and continuity of operations
  • Document, analyze and present experimental results internally and externally
  • Partner with CDMOs and provide technology transfer support to facilitate scale up
  • Interface with cross-functional teams to ensure programs are on track and stakeholders' needs are met
  • Maintain accurate and reliable record keeping including database management, batch records, notebooks, and all other pertinent documentation

Qualifications & Skills:
  • PhD in Chemical/Biomedical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline with >4 years of experience, or BS/MS with >8 years of experience in biopharmaceutical or biotechnology development, including experience in developing scalable fermentation processes for producing plasmid DNA and/or recombinant products
  • In-depth experience and knowledge in fermentation process development, optimization, and process scale-up / scale-down model development
  • Familiarity with strain engineering and biocatalysis
  • Familiarity with performing operations in a cleanroom environment, applying controls to ensure aseptic processing
  • Demonstrated ability to coach and mentor junior researchers
  • Independently motivated and good problem-solving ability
  • Attention to detail and accuracy in developing, reviewing, and following protocols, SOPs, batch records and technology transfer documents is a must
  • Demonstrated ability to work collaboratively across teams to meet project deliverables and timelines
  • Strong communication, decision-making and organizational skills
  • Proficiency with statistical analysis software (e.g., JMP) is highly desired
  • Prior experience partnering with external CDMOs and conducting tech transfers preferred

Pay Range: $155,000 - $170,000

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