Amgen Director Process Development - Process Engineering in Cambridge, Massachusetts

As part of Amgen's Process Development organization, Drug Product Technologies (DPT) continuously strives to be a leader in delivering superior and high-quality aseptic drug product processes & presentations to internal and external manufacturing sites. Within, Drug Product Technologies, we are seeking a highly motivated individual to lead a process engineering group responsible for the technical oversight and support of Amgen's drug product manufacturing processes at Contract Manufacturing sites. This group is part of an integrated external facing team responsible for delivering drug product technology transfers, process optimization, process trouble shooting, non-conformance and change control assessments. Working closely with Quality, Contract Manufacturing and Supply Chain organizations, this individual will manage technical partner engagement on a diverse portfolio of synthetic and biologic products. The position can reside at either Amgen, Thousand Oaks, Amgen, Cambridge or Amgen Dun Laoghaire locations.

JOB RESPONSIBILITIES:

  • Lead the process engineering group to support drug product manufacturing at contract sites and partner with Process Development, Quality, Contract Manufacturing, and Supply Chain to consistently deliver high quality drug product

  • Establish strong working relationships with partner sites to foster technical engagement for program advancement and delivery of reliable and high-quality manufacturing processes

  • In addition to providing leadership to a team of process engineers and scientists to deliver technical excellence, this Director will manage project assignments, executive level communications, and represent Amgen Process Development with external partners and regulatory agencies

  • Resolve and guide the organization on complex technical topics

  • Provide process development expertise for late-phase clinical and commercial DP processing in specific areas such as solid dosage form manufacturing, aseptic processing, process characterization, technology transfer and validation

  • Advice and influence site selection and network expansion decisions

  • Support commercial DP manufacturing operations with technical evaluation of change controls, deviations, corrective and preventative actions, process scale up, validation, and technology transfer

  • As a key contributor to Amgen's commercialization process, the Director must maintain strong partnerships with all Process Development groups, Regulatory, Quality and with Clinical and Commercial manufacturing sites to positively influence Amgen practices and strategies to ensure success through the commercialization lifecycle

  • Advance the organization's acumen on GMP compliance and current regulatory trends and expectations. Fulfill talent management responsibilities for technical personnel including hiring, development, mentoring, training, and compliance to standard operating procedures, regulatory requirements, and quality systems in a GMP environment

  • Recruit and retain highly capable staff that can deliver in a highly matrixed and dynamic environment

Travel Requirements: This position requires (up to 20-30% ) travel to domestic and international manufacturing sites

BASIC QUALIFICATIONS:

Doctorate degree and 4 years of Process Development, Operations or Engineering experience

OR

Master's degree and 8 years of Process Development, Operations or Engineering experience

OR

Bachelor's degree and 10 years of Process Development, Operations or Engineering experience

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

PREFERRED QUALIFICATIONS:

  • Doctorate (Ph.D.) from an accredited college or university in one of the following areas: Chemistry, Chemical Engineering, Biochemistry, and Pharmaceutical Sciences

  • Strong technical understanding of product and process commercialization across synthetics and biologics

  • Excellent communication and cross-functional collaboration skills

  • Strong problem solving, trouble shooting, and communication skills

  • Ability to participate in global cross-functional teams and work effectively in a highly matrixed team environment to drive change, efficiency, and strong cross functional relationships

  • More than 5 years of leadership experience leading / developing staff, managing budgets and allocation of resources, technical transfers to global manufacturing sites

  • Strong understanding of lean / 6 sigma manufacturing concepts, statistical design of experiments and modeling, process control, process monitoring and performance

  • Superior knowledge of aseptic processing and manufacturing of injectable drugs in vials, syringes, cartridges, devices, disposables, and the associated GMP/Device documentation and regulatory filings

  • Experience with aseptic manufacturing, parenteral operations equipment characterization and performance is essential

  • Demonstrated experience with drug product development, process transfer, manufacturing, and troubleshooting

  • Demonstrated experience with regulatory submission and regulatory facility inspections

  • Excellent written, verbal, and presentation skills - ability to distill, craft and present key messages relative to diverse audience requirements

  • Established knowledge of applicable global regulatory requirements. Experience preparing technical sections of regulatory submissions and interacting with regulatory agencies on technical matters

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.

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, or disability status.

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, or disability status.