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Biotech Process Development Jobs in Monterey, MA

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Biotech Process Development information

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$19

$35

$51

How much do biotech process development jobs pay per hour?

As of May 30, 2026, the average hourly pay for biotech process development in Monterey, MA is $35.16, according to ZipRecruiter salary data. Most workers in this role earn between $28.85 and $43.17 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Biotech Process Development, and why are they important?

To excel in Biotech Process Development, you need a strong background in bioprocess engineering, molecular biology, and chemistry, typically supported by a degree in biotechnology or related fields. Familiarity with tools such as bioreactors, chromatography systems, and data analysis software, along with certifications in Good Manufacturing Practice (GMP), is highly valuable. Strong problem-solving skills, attention to detail, and effective teamwork distinguish top performers in this role. These competencies are crucial for optimizing processes, ensuring product quality, and driving innovation in the biotech industry.

What are some common challenges faced by professionals in Biotech Process Development, and how are they typically addressed?

Professionals in Biotech Process Development often encounter challenges related to scaling up processes from the laboratory to commercial production, ensuring product consistency, and meeting strict regulatory standards. Addressing these challenges typically involves close collaboration with cross-functional teams such as quality assurance, regulatory affairs, and manufacturing. Continuous process optimization, thorough documentation, and robust validation protocols are essential strategies to overcome these hurdles and ensure successful product development and commercialization.

What is biotech process development?

Biotech process development refers to the design, optimization, and scale-up of manufacturing processes used to produce biological products, such as pharmaceuticals, enzymes, or vaccines. Professionals in this field work to turn laboratory procedures into efficient, large-scale industrial processes that meet regulatory and quality standards. This often involves selecting suitable equipment, optimizing conditions, ensuring reproducibility, and troubleshooting production issues. The ultimate goal is to produce high-quality products safely, consistently, and cost-effectively.

What is the difference between Biotech Process Development vs Biotech Manufacturing Associate?

AspectBiotech Process DevelopmentBiotech Manufacturing Associate
Primary FocusDesigning, optimizing, and scaling up bioprocesses for product developmentExecuting manufacturing processes to produce biopharmaceuticals at scale
Work EnvironmentLaboratories and pilot plant facilitiesProduction floors and manufacturing plants
Required SkillsProcess design, lab techniques, troubleshootingEquipment operation, quality control, adherence to SOPs
Typical CredentialsBSc/MSc in Biotechnology, Chemical Engineering, or related fieldsBSc in Biotechnology, Biology, or related fields

While both roles are essential in biotech, Biotech Process Development focuses on creating and optimizing processes during product development, whereas Biotech Manufacturing Associates handle the day-to-day production to ensure consistent product quality at scale.

What cities near Monterey, MA are hiring for Biotech Process Development jobs? Cities near Monterey, MA with the most Biotech Process Development job openings:
Biotech Process Development jobs near you

Director of Quality Systems

SHARP STERILE MANUFACTURING LLC

Lee, MA • On-site

$100K - $150K/yr

Full-time

Posted 6 days ago

Job description

Position Summary

The Quality Systems Director is responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) to ensure compliance with cGMP regulations (21 CFR Parts 210 & 211), FDA aseptic processing guidelines, and EU GMP Annex 1.

Duties

and Responsibilities

  • Lead the Quality Systems division within the QA Department, supporting the development, clinical, and commercial activities of pharmaceutical and biotech companies.
  • Oversee and maintain Quality Systems to ensure compliance with regulatory requirements. Key areas of focus include Document Control, Training Programs, Complaint Handling, Supplier Management, and Quality Management Systems (QMS).
  • Manage the Complaint Program, ensuring non-conformances are properly documented, investigated, and resolved through effective root cause analysis and corrective/preventive actions.
  • Oversee the Vendor Approval Program, ensuring outside vendors and suppliers meet compliance requirements through qualification and routine audits.
  • Develop and maintain Quality Agreements with clients and critical suppliers to ensure alignment on compliance and quality expectations.
  • Lead the Client Change Notification Program, ensuring timely and accurate communication of company changes to SSM clients.
  • Oversee the Client Audit Program, collaborating with cross-functional teams (Manufacturing, Quality Control, Warehouse, and Engineering) to maintain a continuous state of audit readiness.
  • Support regulatory inspections, working closely with the Head of Quality to prepare for inspections and respond to regulatory agency observations and requests.
  • Prepare and report quality metrics, providing actionable insights to senior leadership for decision-making.
  • Provide client support for ANDA/NDA submissions and pre-PAI/PLI inspections, ensuring compliance with regulatory expectations.
  • Conduct Annual Product Reviews (APRs) for client products, analyzing trends and ensuring ongoing compliance.
  • Stay current with evolving FDA (21 CFR 210/211), EU GMP, and industry regulations, advising executive management on necessary updates to the Quality Management System (QMS) to maintain compliance and drive improvements.
  • Foster strong cross-functional collaboration and ensure cGMP requirements and quality standards are understood and upheld across the organization.
  • Represent Quality Assurance at senior management, project, board, and review meetings, providing strategic input and leadership on quality initiatives.

Regulatory Responsibilities

Position requires a broad knowledge of life sciences as they relate to the manufacture and testing of pharmaceutical drug products. Thorough knowledge of FDA / EU regulations, particularly as they relate to 21 CFR 210/211 and GMP manufacturing.

Supervisory Responsibilities

  • Provide leadership in daily quality operations, and have employees incorporate QA compliance practices into their daily routines.

Experience

  • Minimum of ten (10) years of pharmaceutical experience in a quality role
  • Minimum of five (5) years in a supervisor/managerial role

Education

  • Minimum of a Bachelor of Science Degree
  • Master’s Degree preferred
  • Auditor certification from an accredited institute preferred

Knowledge, Skills & Abilities

  • In-depth knowledge in current Good Manufacturing Practices (cGMP), analytical chemistry, FDA requirements, ICH guidelines, USP methodology, and EU requirements as they pertain to the pharmaceutical industry.
  • Thorough knowledge of aseptic manufacturing processes.
  • ISO requirements and medical device experience is preferred.
  • Able to travel to vendors, customers and/or other contractual facilities as needed.
  • Technical writing and strong complex problem-solving skills.
  • Ability to effectively and clearly communicate, both written and verbally in English.
  • Detailed oriented

Physical Requirements

  • Ability to sit for prolonged periods of time
  • Ability to lift up to 10lbs
  • Ability to stand for prolong periods of time