Jobs in Great Barrington, MA

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Locums coverage for Psychiatry Job in Massachusetts Duration: ASAP
- Ongoing EMR System: Cerner Coverage Type: Call Only Practice Setting: Inpatient Board certification required Must have Certifications (ATLS, BLS, ACLS, PALS) BLS Located near STOCKBRIDGE, MA.

If you want to hear more about this opportunity, please call MD Staff at .You can also reach us through email at .

Please reference Job ID .

HDAJOBS MDSTAFF

TheSenior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.

This role will:

• Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
• Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
• Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
• Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
• Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
• Identify and order materials required to perform development and manufacturing
• Identify tooling and equipment required to perform development and manufacturing
• Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
• Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
• Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
• Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
• Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
• Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
• Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
• Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
• Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
• Lead/support validation activities including equipment validation and process validation
• Lead problem solving and investigate quality events related to formulation process or batch records
• Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
• Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
• Supervise, mentor and develop team members or relevant personnel across departments

This role requires:

• A minimum of three (3) years of experience in pharmaceutical research and manufacturing
• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
• Experience in sterile manufacturing is preferred
• Experience in lyophilization and terminal sterilization techniques are a plus
• Knowledge of parenteral drug product manufacturing
• Proficient with calculation, data analysis, statistics and applied mathematics

The Director of Quality Operations is a critical leadership position responsible for ensuring the highest standards of quality and compliance in the sterile drug manufacturing process. This individual will lead and oversee key quality operations functions, while ensuring alignment with customer & regulatory requirements and company objectives. The role requires a blend of technical expertise, analytical thinking, and leadership skills to address challenges, optimize processes, foster a culture of continuous improvement across the organization and enhance client relationships.

This role is responsible to:

• Ensure compliance with cGMP, FDA, and other applicable regulatory requirements for sterile drug manufacturing.
• Lead the team in quality oversight of manufacturing processes, ensuring adherence to SOPs and quality standards.
• Drive initiatives to strengthen aseptic technique, contamination control strategies, and data integrity practices.
• Support the development and maintenance of a robust risk management program, ensuring all critical issues are addressed with sustainable solutions.
• Serve as the quality operations representative during internal and external meetings with clients and other entities.
• Respond to client inquiries, quality concerns, and requests in a timely and professional manner.
• Oversee the resolution of client-related deviations, investigations, and CAPAs, ensuring timely closure.
• Provide root cause analysis and implement preventive measures for recurring client concerns.
• Lead cross-functional teams to ensure effective resolution of quality issues impacting clients.
• Facilitate effective communication between clients and internal stakeholders to ensure alignment on quality objectives.
• Keep abreast of changes to quality regulations and guidelines, advise the management team of any business implications of these changes
• Maintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements
• Conduct all work in compliance with FDA, 21 CFR 820, 21CFR 210 and 211 and other regulatory agency requirements
• Lead and direct work and provide feedback to a team of QA Specialists
• Lead, manage and ensure proper training to any relevant change management programs throughout the company

This role requires eight to ten (8-10) years of progressively responsible related quality assurance experience along with a Bachelor's Degree. Subject matter expertise in FDA, EU, and other regulatory agency requirements. Comprehensive knowledge of QA concepts and principles. Knowledge of cGMP principles and RCA tools.