Sr Manager Biopharmaceutical Engineering
6 days ago
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Senior Manager Bioprocess Engineering
Live
What you will do
Lets do this Lets change the world In this vital role you will lead a Downstream BioProcess engineering team at our Rhode Island Site. The Senior Manager will lead a team focused on bioprocess purification processes, drug substance manufacturing support and technology transfer of new products into the facilities. The site operates two multiproduct facilities that manufacture a range of innovative biologic and biosimilar medicines. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility.
Supervise a team of Process Development Engineers focused on downstream purification processes including large scale protein purification using column chromatography and tangential flow filtration.Lead Technology Transfers of bioprocesses of large-scale mammalian cell culture producing monoclonal antibodies and their purification into drug substance at the siteConceive plans and conduct engineering research/investigation in areas of considerable scope and complexity for process improvements.Plan, prioritize and coordinate work of a staff of bioprocess engineers.Interpretation of Processes Characterization for unit operations (chromatography, filtration, tangential flow filtration, filtrations. mixing)Lead efforts for process improvements with manufacturing, process development, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility or process modifications.Collaborate with Plant Managers, Production Managers and Senior Process Development staff to assess needs and update project progress.Validations, and technical reports with document generation and validations strategiesWinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a motivated individual with these qualifications. Basic Qualifications:High school diploma / GED and 12 years of engineering experience ORAssociates degree and 10 years of engineering experience ORBachelors degree and 8 years of engineering experience ORMasters degree and 6 years of engineering experience ORDoctorate degree and 2 years of engineering experienceAND 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 abovePreferred Qualifications:8+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturingProven ability to lead and deliver results in a highly fluid, interactive matrixed environmentExperience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scaleBackground working with commercial manufacture of biologicsStrong understanding cGMP requirementsKnowledge of regulatory filings and inspectionsDownstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP) including technical support for nonconformance investigations and other commercial support activitiesExperience working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for biological moleculesDeep understanding of operational aspects of biopharma and/or engineering industriesAbility to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvementsSkills in analysis of data generated using different analytical techniquesStrong oral and verbal communication and presentation skills enabling strong relationships with internal and external partnersAbility to derive insightful strategies to improve business processesExperience in supervision of direct reports and mentoring of matrix-team member.ThriveWhat 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. 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. 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now for a career that defies imagination Objects in your future are closer than they appear. Join us. 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.-
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