BioSpace
Sr. Associate Manufacturing Production Process Owner
BioSpace, Thousand Oaks, California, United States, 91362
Sr. Associate Manufacturing Production Process Owner
BioSpace – Amgen – Join the Amgen team to help deliver life‑changing therapies to patients worldwide. What You Will Do
In this vital role you will partner with cross‑functional teams including Engineering, Quality, Process Development, and Operations to implement process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen’s ability to deliver life‑changing therapies to patients worldwide. Responsibilities
Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs); serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance. Maintain documentation to accurately reflect operational practices and regulatory requirements. Support implementation of new processes, equipment, and major initiatives within Drug Product operations; collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness. Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations. Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement; develop and implement data‑driven solutions to improve yield, reliability, and compliance. Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements. Support timely investigation and resolution of manufacturing deviations; participate in root cause analyses (RCA) and human performance evaluations. Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness. Assist in developing and executing process validation protocols and reports; collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance. Support establishment of process parameters, control limits, and performance reporting. Support change control activities to ensure GMP, regulatory, and operational compliance. Evaluate and justify process or equipment changes and assist with project execution. Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations. What we expect of you
Basic Qualifications
High school/GED + 4 years Manufacturing support experience OR Associates + 2 years Manufacturing support experience OR Bachelors + 6 months Manufacturing support experience OR Master’s Preferred Qualifications
Advanced degree (Masters or Ph.D.) in Engineering, Biotechnology, or related field Experience in aseptic Drug Product or biologics manufacturing Knowledge of process validation, deviation management, and change control Strong analytical and problem‑solving skills with experience using data visualization tools (Spotfire, JMP, Excel) Excellent written and verbal communication skills and ability to collaborate across functions What you can expect of us
From competitive benefits to a collaborative culture, Amgen supports your professional and personal growth and well‑being. Benefits
A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program or sales‑based incentive plan for field sales representatives. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Location: Simi Valley, CA Expected annual salary range: $120,000–$190,000 (actual salary will vary). Additional benefits include health and welfare plans, financial plans, work/life balance, and career development opportunities. Application information: Amgen does not have a hard application deadline and may continue accepting applications until a suitable candidate is selected. Sponsorship for this role is not guaranteed. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to protected characteristics. Reasonable accommodation is available for individuals with disabilities. Referrals increase your chances of interviewing at BioSpace by 2x.
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BioSpace – Amgen – Join the Amgen team to help deliver life‑changing therapies to patients worldwide. What You Will Do
In this vital role you will partner with cross‑functional teams including Engineering, Quality, Process Development, and Operations to implement process improvements, support new technology introductions, and maintain robust GMP manufacturing performance. Your work will directly contribute to Amgen’s ability to deliver life‑changing therapies to patients worldwide. Responsibilities
Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs); serve as document author, owner, reviewer, or data verifier, ensuring accuracy and compliance. Maintain documentation to accurately reflect operational practices and regulatory requirements. Support implementation of new processes, equipment, and major initiatives within Drug Product operations; collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness. Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations. Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement; develop and implement data‑driven solutions to improve yield, reliability, and compliance. Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire, ensuring configuration alignment with process design and GMP requirements. Support timely investigation and resolution of manufacturing deviations; participate in root cause analyses (RCA) and human performance evaluations. Contribute to the development and implementation of effective corrective and preventive actions (CAPAs) and monitor CAPA effectiveness. Assist in developing and executing process validation protocols and reports; collect, analyze, and interpret validation and process monitoring data to ensure process robustness and compliance. Support establishment of process parameters, control limits, and performance reporting. Support change control activities to ensure GMP, regulatory, and operational compliance. Evaluate and justify process or equipment changes and assist with project execution. Participate in continuous improvement and operational excellence initiatives to enhance safety, quality, and efficiency within DP operations. What we expect of you
Basic Qualifications
High school/GED + 4 years Manufacturing support experience OR Associates + 2 years Manufacturing support experience OR Bachelors + 6 months Manufacturing support experience OR Master’s Preferred Qualifications
Advanced degree (Masters or Ph.D.) in Engineering, Biotechnology, or related field Experience in aseptic Drug Product or biologics manufacturing Knowledge of process validation, deviation management, and change control Strong analytical and problem‑solving skills with experience using data visualization tools (Spotfire, JMP, Excel) Excellent written and verbal communication skills and ability to collaborate across functions What you can expect of us
From competitive benefits to a collaborative culture, Amgen supports your professional and personal growth and well‑being. Benefits
A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program or sales‑based incentive plan for field sales representatives. Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Location: Simi Valley, CA Expected annual salary range: $120,000–$190,000 (actual salary will vary). Additional benefits include health and welfare plans, financial plans, work/life balance, and career development opportunities. Application information: Amgen does not have a hard application deadline and may continue accepting applications until a suitable candidate is selected. Sponsorship for this role is not guaranteed. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to protected characteristics. Reasonable accommodation is available for individuals with disabilities. Referrals increase your chances of interviewing at BioSpace by 2x.
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