Senior Process Technology Manager

Biospectra Inc-posted 4 months ago

Full-time • Senior

Bangor, PA

251-500 employees

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BioSpectra is seeking a Senior Process Technology Manager to lead the process technology team and drive excellence in production operations. Responsibilities include designing and implementing new production processes, monitoring performance through KPIs, leading process improvement initiatives, and ensuring the successful commercialization of new products. A critical component of this role involves developing and executing the process validation strategy across BioSpectra North American Facilities, while ensuring compliance with all applicable regulations and industry standards.

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.

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.
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.
Ability to develop and execute a process validation strategy, ensuring compliance with cGMP and other regulatory requirements.
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.

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.

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