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For your reference, we have included the original job posting below.
Principal Scientist
Job Number:
41708839
Company Name:
Amgen
Job Location:
Cambridge, MA US
Job Categories:
Science & Biotech Healthcare & Medical
Principal Scientist
SUMMARY
A Principal Scientist of the CPR&D Department is responsible for leading Project Groups to prepare Amgen's small molecule API candidates through all phases of development and to guide teams and staff towards creative, innovative and robust solutions to prepare small molecule drug candidates.
KEY RESPONSIBILITIES:
FUNCTIONS (Duties/ Accountabilities*): • Accountable for ensuring that the CPR&D vision, mission, charter and strategy are implemented and upheld • Ensures that performance and career development are effectively managed within the department • Allocates resources, measures, monitors, and reports on performance against departmental goals and project plans • Upholds partnership agreements (e.g. AR&D, Pharm R&D, Quality, and Regulatory) • Assumes project representative responsibilities and/or designates responsibilities as appropriate • Participates in company-wide and department level activities (e.g. budgeting, capital allocation, project assignment, alignment initiatives, setting vision/direction/strategy and technology development) • Reviews and approves the departmental technical and regulatory documents • Participates in or organizes departmental committees to address departmental problem solving, and activities • Ensures that industry standards and best practices that fits Amgen's business needs are effectively applied • Stays abreast of issues that may impact CPR&D business • Represent CPR&D as a scientific, regulatory and technical expert • Evaluates, resolves and/or escalates issues
SCIENTIFIC/TECHNICAL • Develop technology to deliver Amgen's API candidates in a practical, efficient and safe manner. • Manage drug substance teams and work cross-functionally with analytical and drug product representatives to delivery drug substance manufacturing processes in a phase appropriate manner. • Manage and collaborate in cross-functional CMC teams to develop Amgen's pipeline. • Work cross-functionally to deliver CMC regulatory documents and supporting documentation in support of Amgen's small molecule regulatory filings. • Perform management responsibilities associated to development, coaching, mentorship of scientific staff, as well as the performance evaluation of direct reports. • Deliver processes amenable to cGMP operation and carry out deliveries of drug substance in a cGMP manufacturing environment.
TEAM EXPERIENCE • Routinely leads and contributes to drug substance development teams (e.g., product and process development teams, product quality teams) by providing leadership in scientific, technical and regulatory issues • Identifies resources needed and establishes priority for projected activities. • Facilitates cohesiveness and builds team spirit. • Ensures that effective teams are built and sustained within the department • Makes others feel respected, valued and understood
ORAL AND WRITTEN COMMUNICATION • Communicates effectively with others, using appropriate diplomacy and sensitivity • Effectively organizes and conducts meetings • Effectively communicates in individual and group situations • Consistently demonstrates facilitation and listening skills • Establishes and maintains effective communication mechanisms to keep staff appropriately informed
SUPERVISING OTHERS [MAY HAVE DIRECT REPORT(S)] • Ensures that safe laboratory practices are followed. • Provides mentoring and expertise to less-experienced staff • Achieves work through others who may or may not report directly to them. • Motivates, develops, and coaches staff while promoting team collaboration • Applies effective management practices in the direction and development of others • Organizes the execution of synthetic processes for manufacture of Amgen's drug substance candidates using GLP and GMP procedures
LEADERSHIP AND INFLUENCE
DECISION MAKING AND JUDGMENT
Basic Qualifications • Doctorate degree & 2 years of directly related experience OR • Master's degree & 6 years of directly related experience OR • Bachelor's degree or & 8 years of directly related experience OR • Associate's degree & 10 years of directly related experience OR • High school diploma / GED & 12 years of directly related experience
Preferred Qualifications • Ph.D. or equivalent in Chemistry (Organic Chemistry) and typically 8+ years of relevant experience in the pharmaceutical or related industry which includes drug substance project leadership and supervision of senior level scientific staff • Experience with catalytic chemistry both heterogeneous and homogenous systems and their successful implementation into processes to produce APIs on a range of scales • Experience training and developing scientific staff across disciplines • Experience solving issues in the development of a commercial large-scale chemistry process • Familiarity with the use of design of experiments (DOE) and Process Analytical Technology (PAT) techniques • An external scientific track record which may include peer reviewed publications, scientific conference participation or participation in industry working groups or panels • Experience with the use of analytical instruments (HPLC, NMR, IR and MS) and interpreting the scientific data based upon these techniques • Experience implementing chemistry with contract manufacturing organizations • Understanding of regulatory requirements for chemistry, manufacturing and controls (CMC) production including cGMP's and ICH guidelines
