Direct experience with validation of processes in synthetic drug substance manufacturing or aseptic drug product filling is required. Experience with qualification/validation of primary and secondary packaging processes, including device / combination products is highly desired, but not required. The candidate should have experience with tech transfer / NPI and be experienced with process validation and cleaning validation. Some experience and understanding of implementing statistical methods for determining appropriate sampling plans and acceptance criteria, based on level of risk, is beneficial. Prior experience with, or willingness to learn, other modalities, including biologic drug substances are also desired. The role will be located in Singapore and require occasional, in-frequent, travel to contract manufacturing locations in China, India or Japan. Candidates located in other JAPAC regions may be considered based on qualifications.
Roles & Responsibilities
Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will include tech transfers, new product introductions, and ongoing validation maintenance activities.
Translate Amgen requirements into the language of the CMO.
Identify and assess validation/quality risks to enable risk-based decisions.
Validation document author/approver.
Oversight of synthetic API manufacturing process validation and cleaning validation.
Oversight of aseptic DP filling process validation and cleaning validation, as well as aseptic processing and sterilization validation oversight (media fill, autoclave validation, EM)
Oversight of packaging process qualification, device and combination product qualifications.
Determine appropriate sample plans and acceptance criteria for primary and secondary packaging processes.
Implement statistical methods to create risk-based sampling plans and acceptance criteria.
Prepare materials/documents (playbooks) for topics to be presented during audits/inspections.
Perform validation change control assessments.
Review/approve validation deviations.
Review/approve Master Batch Records.
Escalate issues to Validation/Quality management, as needed.
Author Validation sections of Marketing Applications.
Write/review responses to regulatory questions (RTQs).
Drive Operational Excellence and Champion Change.
Authority
Determine outcome of validation activities
Decision to approve or reject validation documentation
Provide input on Validation position on related topics and strategy for the site
Decision to approve Master batch Records
This role may require working in shifts or extended hours within the same shift to support global timezones.
What we expect of you
Doctorate degree with 2 years of directly related experience; or
Master's degree with 6 years of directly related experience; or
Bachelor's degree with 8 years of directly related experience.
Prior experience serving as Validation lead for NPI or tech transfer of manufacturing processes.
Relevant experience in validation of synthetic drug substance manufacturing.
Relevant experience in validation of aseptically filled drug product manufacturing processes.
Relevant experience in qualification of finished drug product and packaging processes.
Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them
Working foundation in cleaning validation and aseptic process simulation.
Experience in resolving complex deviations associated with validation studies.
Understanding of the applicable manufacturing/testing processes (i.e. Synthetic API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
Proven experience in designing and/or improving processes at conceptual level
Understanding of industry requirements/expectations that comprise a robust Validation package.
Excellent analytical and troubleshooting skills.
Strong verbal and written communication skills
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation.
Ability to manage multiple priorities successfully.
Team-oriented, with a focus on achieving team goals
Strong presentation and public speaking skills.
Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.
What you can expect of us
At Amgen, you'll work alongside talented colleagues in an environment that values innovation, collaboration, and growth. We are committed to helping you develop your career while contributing to work that matters for patients.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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 as we 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.
.
