Location:

Thousand Oaks, CA Travel:

Up to 10% domestic and international travel

KEY RESPONSIBILITIES

Support the development, scale-up, tech transfer and manufacturing execution of cGMP clinical and commercial downstream purification processes including, but not limited to harvest, clarification, chromatography (Protein A, AEX, CEX, etc), viral filtration, UF/DF, and sterile filtration. Apply engineering principles and statistical analysis in order to: Identify, develop and implement downstream process improvements into the manufacturing facility. Resolve technical issues observed during scale-up and/or manufacturing execution of purification processes. Manage escalation and on the floor support as required to achieve successful scale-up and manufacturing objectives. Interface with process development teams to ensure processes are robust and are designed to deliver all quality attributes and enable manufacturing success. Collaborate with Process Development, Quality, Manufacturing, Regulatory, Validation and Supply Chain to drive continuous improvements into our business processes. Lead site activities for continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management Ensure safety and compliance of process development activities Collaborate with other site-functions and network drug substance teams in delivering plant goals Lead cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives Ensure manufacturing operations are aligned with the registered process Provide support for regulatory filing, inspection, and other CMC activities Serve as member of the

ATO DSTE

leadership team utilizing network thinking and innovative approaches to advance the drug substance organizational capabilities Supervising Others / Team Experience Create multi-year technical strategies for advancing business performance. Ensures that safe practices are followed. Provides mentoring and expertise to staff on the downstream team Motivates, develops, and coaches staff while promoting team collaboration Applies effective management practices in the direction and development of others Leadership and Influence Identifies and negotiates resources and develops timelines for project activities. Collaborates within the department and interdepartmentally. Provides scientific and technical leadership Ensure department staff are adequately developed and trained Provides adequate feedback through coaching and effective performance appraisal and development planning Initiates and encourages scientific collaboration with groups outside the department Manage project resources (material, labor, time, etc.), and elevate relevant issues to project lead and line-management Build and maintain effective collaborations with partner organizations Decision Making and Judgment Anticipates, proactively detects, and addresses problems related to departmental and interdepartmental activities. Inform and consults department head and senior staff appropriately What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic individual we seek is a collaborative partner with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of biologics process development or commercial-scale technical support experience OR Masters degree and 6 years of biologics process development or commercial-scale technical support experience OR Bachelors degree and 8 years of biologics process development or commercial-scale technical support experience OR Associates degree and 10 years of biologics process development or commercial-scale technical support experience OR High school diploma / GED and 12 years of biologics process development or commercial-scale technical support experience In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

8+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP) 5+ years directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources. Strong and in-depth expertise in purification processes Experience in process scale-up, technology transfer, process validation, troubleshooting, and complex investigation Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders Experience developing staff to reach their full potential Knowledgeable in regulatory filings and inspections Familiarity in operational aspects of commercial biopharma manufacturing Familiarity in statistical analysis, analytical methods, and product quality attributes relevant to biological processing What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: 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 for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Sr. SAP Tax & Vertex Engineer Warsaw - Poland Advisor/Sr. Advisor - Bioconjugation Scientist Lebanon, Indiana Staff Process Engineer Tustin, California, United States","accountId","9156215","https://jobs.biospace.com/job/3068735/senior-manager-drug-substance-technology-and-engineering","location",{"_541":542,"_543":544},"status","active","isDiscoverable","isSearchable","isSpotlight","isDraft","careerSkills",[409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451],"requiredEducation","high_school","benefitCategories",[407,408],"isEmailRequired","isPhoneRequired","titleSearch","Technology Engineering 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Senior Manager Drug Substance Technology & Engineering