SUMMARY We are looking for a Manager Manufacturing to support our Drug Substance Manufacturing operations at Puerto Rico site, Amgen Manufacturing Limited - a state-of-the-art biotechnology facility. As Manager Manufacturing you will be responsible for leading and supervising either a small manufacturing production area, or a section of a larger production area in a Media Prep-Bulk Manufacturing organization. Consistent with our core leadership value of "Develops the Best Team," we are seeking leaders that prioritize the development of talent. We expect managers to exemplify strong leadership and champion self-awareness and career development. Ways that you will get to display your leadership acumen in this role include but are not limited to: Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages You will develop an understanding of your team's career objectives and serve as a thought-partner in their career development plans Assist staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives You'll resolve critical gaps in the organization's internal capabilities and skillsets, including strategic external recruiting as needed Identifying diverse, qualified successors for key positions Responsible for management and oversight of one or more production or production support functions Ensures that clinical and licensed products are produced according to current Good Manufacturing Practices (cGMP) and other applicable regulations Ensures that manufacturing facilities, equipment, processes, and procedures are compliant with cGMP requirements and/or other applicable regulations Ensures that written procedures describing the manufacturing operations are controlled and followed Ensures production activities follow approved cGMP procedures and are documented according to cGMP requirements Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured Ensures that there is an adequate number of personnel who possess an adequate combination of education, experience and training in accordance with cGMP requirements Ensures that area staff are trained to perform assigned production activities Ensures that written procedures describing the manufacturing process are controlled and followed Ensures that deviations are reported promptly to the Quality unit, investigated and closed per procedures Ensures that corrective actions and preventive actions (CAPA) are managed and closed according to procedures Ensures the requirements of the Quality Management System are fulfilled Ensure that the INCA events are managed and closed according to procedures Alerts senior manager of significant quality, compliance, supply and safety risks Provides input for Management Reviews Responsible for planning production activities for assigned areas and adherence to schedule Supports Continual Improvement initiatives, programs and projects Support non-standard shift (first, second, third and 12 hrs. shifts including extended hours), as per business needs Support audits readiness and participated during audits response EDUCATION/LICENSES Doctorate degree or Master's degree and 3 years of Manufacturing/Operations experience in GMP regulated industry or Bachelor's degree and 5 years of Manufacturing/Operations experience in GMP regulated industry And Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources. PREFERRED QUALIFICATIONS Education discipline/background in Business Administration, Life Sciences and/or Engineering Flexibility to work different work schedules Senior or Managerial manufacturing experience NC/CCMS/CAPA Skills and competencies in the following areas: Leadership and teambuilding Verbal communication Written Communication including technical writing skills Conflict Resolution Analytical Problem Solving Project Management Coaching, Mentoring and Counseling Ability to be flexible and manage change Regulatory requirements Computer literacy Scheduling Presentation Skills 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 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.
