BioSpectra, Inc. · 4 months ago
Senior Process Technology Manager
Bangor, PA
Full-time
Onsite
Senior Level
5+ years expBioSpectra, Inc. is a growing company and a major supplier to the bio-pharmaceutical industry. They are seeking a Senior Process Technology Manager to lead the process technology team, drive excellence in production operations, and ensure compliance with regulations while developing new production processes.
ChemicalManufacturingPharmaceutical
Responsibilities
Lead, mentor, and guide the process technology team for high performance and professional development
Design and develop new production processes, optimizing for efficiency, quality, and cost-effectiveness
Establish, monitor, and report on key process performance indicators (KPIs) to track progress and identify areas for improvement
Develop and implement strategies for continuous process improvement, utilizing methodologies to enhance efficiency and quality
Ensure the adequate and timely completion of Product Commercialization activities, collaborating with other relevant teams
Develop and execute the Process Validation Strategy for all BioSpectra North American Facilities, ensuring compliance with cGMP and other regulatory requirements
Identify and resolve production issues promptly, applying sound engineering principles and problem-solving skills
Oversee the adequate completion of process development and process validation protocols and reports, ensuring accurate documentation
Select appropriate equipment and utilities specific to new and existing processes, considering performance and cost-effectiveness
Ensure the adequate development and execution of Process Qualifications
Establish requirements to ensure processes and equipment remain in a qualified state, maintaining documentation and overseeing re-qualification activities as needed
Qualification
Required
Degree in Chemical Engineering or other related field
Minimum of five or more years' experience in technical leadership with a manufacturer of products and/or ingredients in the life science, bio-pharmaceutical, food, or fragrance industries
Leading a technical team and an organization to achieve world-class process performance
Demonstrated excellence in designing, and optimizing manufacturing processes
Experience in driving continuous process improvements
Working knowledge of SPC, DOE, Six Sigma, Lean and/or other process improvement methodology and systems
Results-oriented leadership with a proven ability to deliver tangible outcomes and measurable results on the commercialization of products
Demonstrated technical and mechanical ability to diagnose, decide on a course of action and resolve manufacturing process issues
Demonstrated ability to develop and execute a process validation strategy
Ability to write, orally communicate and effectively communicate technical information in a concise and understandable way
Demonstrated ability to use IT software technology and systems, including statistical software to drive process performance excellence
Preferred
Effective working knowledge of validating and qualifying processes and equipment consistent with FDA guidance and cGMP requirements
Understanding of how to execute work consistent with ICH quality guidelines
Company
BioSpectra, Inc.
BioSpectra Inc.
201-500 employees
Funding
Current Stage
Growth StageRecent News
2023-08-09
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