Biotech Process Development Jobs in Ohio (NOW HIRING)

Career Category
Engineering
Job Description
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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Director Engineering
What you will do
Let's do this. Let's change the world. In this role as a member of the AOH Engineering leadership team, the director will provide leadership, strategy, and tactical direction for the engineering and maintenance teams supporting the assembly and packaging lines in AOH 24/7 operation. This position reports directly to the Executive Director F&E and will manage a dynamic team whose responsibilities include engineering and maintenance.
Key responsibilities include:

• Ensure safety of all personnel during plant operations and engineering activities
• Ensure that all staff are adequately trained and comply with all GMP standards and procedures
• Maximize staff productivity and the efficient use of available resources
• Maintain and improve plant capability and equipment reliability in partnership with plant leadership and other technical staff
• Leverage resources to support ongoing department capital project investment
• Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects, and implement as required
• Maintain and develop key performance indicators, supervise, assess, and develop staff, and ensure that all targets and milestones are completed on time and on budget
• Interface with a diverse Amgen internal network including AOH clients (plant and area directors and front-line managers), Facilities & Engineering leadership (Engineering and Automation), Engineering Technical Authority, Technology, Global Capital Project Management, Environmental Health and Safety, and Process Development

Specific responsibilities include:

• Oversee a safe and compliant workforce working with a highly utilized commercial operations site
• Provide day-to-day, small project, and plant shut-down support
• Work with a diverse group of clients, technologies, and integrated systems in product development all in a GMP and highly regulated setting
• Manage partners and drive new business processes to ensure continuous and sustained improvements
• Ensure readiness and compliance for internal audits, external agency audits, and partner visits
• Present engineering plans, progress, and status updates to project stakeholders
• Review and approve proposed engineering designs, and equipment improvements and changes
• Perform administrative and oversight functions in approving proposals and expenditures
• Participate in the development of department expenditure requests and partner with the projects teams to define the best engineering solution inclusive of long-term equipment performance
• Deliver effective troubleshooting and timely response to reduce downtime
• Drive robust equipment reliability

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is a leader and a strong strategic problem solver with these qualifications.
Basic Qualifications:
Doctorate degree and 4 years of Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies experience
OR
Master's degree and 8 years of Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies experience
OR
Bachelor's degree and 10 years of Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies experience
In addition to meeting at least one of the above requirements, you must have at least 4 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:

• Typically, 12+ years of relevant work experience with 8+ years' experience in an operations / manufacturing environment
• Typically, 10+ years' experience with regulated environments (i.e. FDA/cGMP, OSHA, EPA) preferred
• Must have experience leading an engineering department in a regulated GMP environment
• Knowledge of GMP manufacturing equipment and their design and operational aspects
• Excellent organizational and administrative leadership skills
• Ability to work and influence locally and across Amgen's network
• Ability to work in a highly dynamic organization with a demanding environment
• Must have excellent verbal and written communication skills, as well as the ability to actively, and cooperatively work with cross-functional teams
• Demonstrated team motivation, leadership, and mentoring/staff development skills
• Understand regulatory trends in the industry. Direct experience with FDA or equivalent regulatory body
• Ability to manage multiple resource demands and prioritization, assess project effectiveness, and efficiency and manage demand
• Proven ability to motivate staff and establish and communicate visions/missions
• Proven ability to delegate and manage the work of others
• Demonstrate a high degree of creativity, foresight, and mature judgment in anticipating and solving problems by translating data into actionable solutions

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, we'll 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, including remote and hybrid 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
Sponsorship
Sponsorship for this role is not guaranteed.
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.
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.
Salary Range
184,382.85USD -249,459.15 USD