Senior Engineer Manager Projects - Upstream

Amgen • Holly Springs, NC

1d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Engineer Manager Projects - Upstream Live What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for the department capital portfolio and project management of small capital projects at the drug substance facility in ANC. Reporting to the Director of Engineering, the Sr Manager will provide technical leadership to a team of manufacturing support engineers supporting commercial production operations with emphasis on Drug Substance bioprocessing equipment. Establish clear expectations and priorities to staff. Encourage a culture of continuous improvement, partnership, and knowledge sharing. Provide development opportunities, feedback, and actively listen to staff. Cultivate a culture of safety ensuring the well-being of all staff members and drive efforts to reduce safety risks. Provide technical support to troubleshoot, identify and resolve process and system issues as needed. Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance. Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners). Ensure all tasks and projects are accomplished in a safe manner. Employ Business Analytics to assess performance and identify improvement opportunities Lead Sustainability Program Management of Multi-faceted, Cross-functional, Network Initiative Collaborates with leadership to set strategy and business objectives. Foster and maintain relationships with key stakeholders. Establish balanced scorecard of strategic and operational key performance indicators (KPI) in line with industry best practices to monitor, trend and analyze equipment performance, sustainability and reliability programs. Ensure action plans are established to address performance gaps or opportunities. Communicate gaps and establish the proper escalation process to the stakeholders Identify opportunities to optimize organizational efficiency. Leads engineering and contractor evaluation and selection process Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Engineering and/or Project Management experience OR Associate’s degree and 10 years of Engineering and/or Project Management experience OR Bachelor’s degree and 8 years of Engineering and/or Project Management experience OR Master’s degree and 6 years of Engineering and/or Project Management experience OR Doctorate degree and 2 years of Engineering and/or Project Management experience Additionally: 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: Bachelor’s degree in chemical engineering or related technical field 5+ years’ experience in engineering in a manufacturing support environment with 3+ years’ experience in the Pharmaceutical or Biotechnology industries Demonstrated people management/leadership experience Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP and Production Services. Upstream unit operation experience such as bioreactor or harvest equipment Familiarity designing, troubleshooting, and operating equipment used in cell culture manufacturing including disposable technologies Experience with Tech Transfer, Process Design, and Commissioning & Qualification Experience with validation and change control methodology Direct experience with regulated environments (i.e., cGMP, OSHA, EPA) including detailed understanding of cGMPs Excellent written and verbal communication skills Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture Familiarity with designing and operating equipment used in biopharmaceutical manufacturing Demonstrated experience in applying Operational Excellence and Lean Manufacturing Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. Amgen offers a Total Rewards Plan comprising 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 including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com #AmgenNorthCarolina Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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. . Salary Range 158,914.00 USD - 191,350.00 USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

Requirements

• High school diploma / GED and 12 years of Engineering and/or Project Management experience OR
• Associate’s degree and 10 years of Engineering and/or Project Management experience OR
• Bachelor’s degree and 8 years of Engineering and/or Project Management experience OR
• Master’s degree and 6 years of Engineering and/or Project Management experience OR
• Doctorate degree and 2 years of Engineering and/or Project Management 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

Nice To Haves

• Bachelor’s degree in chemical engineering or related technical field
• 5+ years’ experience in engineering in a manufacturing support environment with 3+ years’ experience in the Pharmaceutical or Biotechnology industries
• Demonstrated people management/leadership experience
• Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP and Production Services.
• Upstream unit operation experience such as bioreactor or harvest equipment
• Familiarity designing, troubleshooting, and operating equipment used in cell culture manufacturing including disposable technologies
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification
• Experience with validation and change control methodology
• Direct experience with regulated environments (i.e., cGMP, OSHA, EPA) including detailed understanding of cGMPs
• Excellent written and verbal communication skills
• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment
• Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
• Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture
• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing
• Demonstrated experience in applying Operational Excellence and Lean Manufacturing

Responsibilities

• Responsible for the department capital portfolio and project management of small capital projects at the drug substance facility in ANC.
• Provide technical leadership to a team of manufacturing support engineers supporting commercial production operations with emphasis on Drug Substance bioprocessing equipment.
• Establish clear expectations and priorities to staff.
• Encourage a culture of continuous improvement, partnership, and knowledge sharing.
• Provide development opportunities, feedback, and actively listen to staff.
• Cultivate a culture of safety ensuring the well-being of all staff members and drive efforts to reduce safety risks.
• Provide technical support to troubleshoot, identify and resolve process and system issues as needed.
• Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance.
• Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners).
• Ensure all tasks and projects are accomplished in a safe manner.
• Employ Business Analytics to assess performance and identify improvement opportunities
• Lead Sustainability Program Management of Multi-faceted, Cross-functional, Network Initiative
• Collaborates with leadership to set strategy and business objectives.
• Foster and maintain relationships with key stakeholders.
• Establish balanced scorecard of strategic and operational key performance indicators (KPI) in line with industry best practices to monitor, trend and analyze equipment performance, sustainability and reliability programs.
• Ensure action plans are established to address performance gaps or opportunities.
• Communicate gaps and establish the proper escalation process to the stakeholders
• Identify opportunities to optimize organizational efficiency.
• Leads engineering and contractor evaluation and selection process

Benefits

• Amgen offers a Total Rewards Plan comprising 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 including:
• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED