BioSpace
Senior Process Development Engineer
BioSpace, Thousand Oaks, California, United States, 91362
Overview Senior Process Development Engineer role at BioSpace. Join Amgen’s Mission of Serving Patients. The position supports Amgen’s Drug Product Technologies (DPT) in Thousand Oaks, CA, focusing on aseptic fill-finish manufacturing, technology transfer, process characterization, validation and ongoing process verification.
Ensure you read the information regarding this opportunity thoroughly before making an application. What You Will Do
Lead or support new product introductions and lifecycle changes into the Thousand Oaks DP manufacturing facility as the Process Development lead, integrating product process design with site procedures and capabilities; serve as the Process Development SME after tech transfer. Collaborate with multiple plant functions to ensure aseptic fill-finish equipment and procedures are fully characterized to enable efficient tech transfers of Amgen’s clinical and commercial portfolio. Act as point of contact to provide knowledge of site process capabilities and practices. Support make-a-batch exercises to determine facility fit and identify gaps. Design, implement and document off-line and on-site DP characterization studies. Plan and execute floor support for engineering, machinability, and PPQ runs to ensure successful product commercialization. Author and own high-quality process technology transfer and other technical documents. Process Validation & Regulatory Support
Develop validation plans and support execution of PPQs for commercial manufacturing; author and review validation protocols, assessments and reports within Amgen quality systems. Ensure site processes adhere to global regulatory standards, Amgen quality requirements and site policies including safety and training. Contribute to regulatory filings as part of the NPI process; author, review and respond to regulator questions; support pre-Licensure and GMP inspections. Manufacturing Support
Provide frontline process development expertise for clinical and commercial drug product manufacturing during sterile processing, process characterization, tech transfer, validation, and ongoing manufacturing. Lead or assist in deviations, exception resolution and root cause analysis to ensure smooth operations and continued supply. Apply science-based methodologies to identify true root causes with clear, evidence-based reasoning to support patient safety. Conduct risk assessment for drug product operations and implement CAPAs for continuous improvement. Collaborate with manufacturing, engineering, quality and drug product technologies to provide robust, coordinated support to manufacturing. Identify and implement new process improvements for current and new sterile operations to increase reliability and efficiency. Work with multi-functional teams on FMEAs, risk assessments, and regulatory filing subsections; present findings and project status. Influence and support robust tactical and strategic objectives related to visual inspection and evolving regulatory expectations within the Amgen network. Provide technical management and portfolio management for process improvement and new technology projects. Aseptic DP Technology Leadership
Serve as SME for new DP manufacturing technologies introduced into B20; collaborate with global teams for best practices and advancements. Drive innovations in aseptic processes and technologies to align with regulatory expectations and quality standards; lead to continuous improvement in GMP DP manufacturing. Design, execute and document primary data packages for new technology development, with expertise in aseptic processing and unit operations characterization. Support expansion projects by supporting equipment user requirements, FAT, process characterization and validation in sterile fill-finish areas. DP Network Support
Establish strong relationships with partner sites across the DP Manufacturing network to share best practices and improvements. Act as single point of contact to drug product teams to guide knowledge of site process capabilities and practices in drug substance freezing/thawing, formulation, filling, lyophilization and visual inspection. What We Expect Of You We are diverse and rely on unique contributions to serve patients. The ideal candidate will have qualifications in engineering and operations as described below. Basic Qualifications
Doctorate degree OR Masters degree and 2 years of Engineering and/or Operations experience OR Bachelor's Degree and 4 years of Engineering and/or Operations experience OR Associate's degree and 8 years of Engineering and/or Operations experience OR High school diploma/GED and 10 years of Engineering and/or Operations experience Preferred Qualifications
Advanced degree in engineering, biotechnology, life sciences or related field 4+ years of pharmaceutical/biotechnology industry experience including process development, characterization and tech transfers Experience leading functional deliverables from planning to completion with measurable business impact Experience characterizing processes such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection Project management skills and ability to manage multiple projects Leadership of multi-functional teams to advance complex projects; ability to influence decisions Ability to innovate, collaborate in a multi-functional team, and adapt quickly Independent design and execution of characterization studies and related documentation Proficiency in problem solving, critical thinking, and technical communication Strong knowledge of Quality systems and Drug Product Manufacturing (GMP) Strong interpersonal skills to build technical relationships Self-motivation, adaptability, and positive attitude Excellent oral and written communication skills Ability to escalate issues to project lead and management Ability to learn new techniques and manage multiple tasks with accurate record-keeping What You Can Expect From Us Amgen supports professional and personal growth, competitive benefits, and a collaborative culture. Details on the total rewards plan, including health and welfare plans, retirement/savings, and flexible work models, are provided with the application. Application deadline: Amgen does not have a fixed deadline; applications are reviewed as they are received until a candidate is selected. Equal Opportunity and Accessibility Amgen is an Equal Opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. Reasonable accommodations are available in the job application or interview process upon request.
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Ensure you read the information regarding this opportunity thoroughly before making an application. What You Will Do
Lead or support new product introductions and lifecycle changes into the Thousand Oaks DP manufacturing facility as the Process Development lead, integrating product process design with site procedures and capabilities; serve as the Process Development SME after tech transfer. Collaborate with multiple plant functions to ensure aseptic fill-finish equipment and procedures are fully characterized to enable efficient tech transfers of Amgen’s clinical and commercial portfolio. Act as point of contact to provide knowledge of site process capabilities and practices. Support make-a-batch exercises to determine facility fit and identify gaps. Design, implement and document off-line and on-site DP characterization studies. Plan and execute floor support for engineering, machinability, and PPQ runs to ensure successful product commercialization. Author and own high-quality process technology transfer and other technical documents. Process Validation & Regulatory Support
Develop validation plans and support execution of PPQs for commercial manufacturing; author and review validation protocols, assessments and reports within Amgen quality systems. Ensure site processes adhere to global regulatory standards, Amgen quality requirements and site policies including safety and training. Contribute to regulatory filings as part of the NPI process; author, review and respond to regulator questions; support pre-Licensure and GMP inspections. Manufacturing Support
Provide frontline process development expertise for clinical and commercial drug product manufacturing during sterile processing, process characterization, tech transfer, validation, and ongoing manufacturing. Lead or assist in deviations, exception resolution and root cause analysis to ensure smooth operations and continued supply. Apply science-based methodologies to identify true root causes with clear, evidence-based reasoning to support patient safety. Conduct risk assessment for drug product operations and implement CAPAs for continuous improvement. Collaborate with manufacturing, engineering, quality and drug product technologies to provide robust, coordinated support to manufacturing. Identify and implement new process improvements for current and new sterile operations to increase reliability and efficiency. Work with multi-functional teams on FMEAs, risk assessments, and regulatory filing subsections; present findings and project status. Influence and support robust tactical and strategic objectives related to visual inspection and evolving regulatory expectations within the Amgen network. Provide technical management and portfolio management for process improvement and new technology projects. Aseptic DP Technology Leadership
Serve as SME for new DP manufacturing technologies introduced into B20; collaborate with global teams for best practices and advancements. Drive innovations in aseptic processes and technologies to align with regulatory expectations and quality standards; lead to continuous improvement in GMP DP manufacturing. Design, execute and document primary data packages for new technology development, with expertise in aseptic processing and unit operations characterization. Support expansion projects by supporting equipment user requirements, FAT, process characterization and validation in sterile fill-finish areas. DP Network Support
Establish strong relationships with partner sites across the DP Manufacturing network to share best practices and improvements. Act as single point of contact to drug product teams to guide knowledge of site process capabilities and practices in drug substance freezing/thawing, formulation, filling, lyophilization and visual inspection. What We Expect Of You We are diverse and rely on unique contributions to serve patients. The ideal candidate will have qualifications in engineering and operations as described below. Basic Qualifications
Doctorate degree OR Masters degree and 2 years of Engineering and/or Operations experience OR Bachelor's Degree and 4 years of Engineering and/or Operations experience OR Associate's degree and 8 years of Engineering and/or Operations experience OR High school diploma/GED and 10 years of Engineering and/or Operations experience Preferred Qualifications
Advanced degree in engineering, biotechnology, life sciences or related field 4+ years of pharmaceutical/biotechnology industry experience including process development, characterization and tech transfers Experience leading functional deliverables from planning to completion with measurable business impact Experience characterizing processes such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection Project management skills and ability to manage multiple projects Leadership of multi-functional teams to advance complex projects; ability to influence decisions Ability to innovate, collaborate in a multi-functional team, and adapt quickly Independent design and execution of characterization studies and related documentation Proficiency in problem solving, critical thinking, and technical communication Strong knowledge of Quality systems and Drug Product Manufacturing (GMP) Strong interpersonal skills to build technical relationships Self-motivation, adaptability, and positive attitude Excellent oral and written communication skills Ability to escalate issues to project lead and management Ability to learn new techniques and manage multiple tasks with accurate record-keeping What You Can Expect From Us Amgen supports professional and personal growth, competitive benefits, and a collaborative culture. Details on the total rewards plan, including health and welfare plans, retirement/savings, and flexible work models, are provided with the application. Application deadline: Amgen does not have a fixed deadline; applications are reviewed as they are received until a candidate is selected. Equal Opportunity and Accessibility Amgen is an Equal Opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. Reasonable accommodations are available in the job application or interview process upon request.
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