Career CategoryProcess Development
Job DescriptionProcess Development Principal ScientistWhat you will doLet's do this. Let's change the world. In this vital role you will joining Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) synthetic medicines (oligonucleotides and small molecules).
In this vital role as an Attribute Sciences team lead and group lead you will work to provide strategic analytical leadership to teams developing commercial manufacturing processes for synthetic and hybrid molecules and collaborate closely with Drug Substance, Drug Product and Product Quality colleague
- Lead all attribute and analytical aspects of a program in pivotal clinical process development while working cross-functionally within a Product development team
- Define analytical control strategies and implement methodologies for development of late phase clinical programs including analytical method development and optimization
- Lead method transfer and support cGMP manufacturing activities at internal manufacturing, and contract manufacturing and testing sites
- Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Answer analytical and product quality questions from health authorities
- Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification
- Provide expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development
- Help to define strategies that improve the effectiveness and efficiency of the Attribute Sciences department
- Maintain current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities and apply this knowledge to the evaluation and development of new methodologies
- Recognized as a scientific resource in area of expertise who can provide mentorship to junior staff.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is a leader with these qualifications.
Basic Qualifications:Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of [Job Code's Discipline and/or Sub-Discipline] experience
OR
Master's degree and 6 years of Scientific experience
OR
Bachelor's degree and 8 years of Scientific experience
Preferred Qualifications:- PhD with 3+ plus years of industry experience.
- Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques with an emphasis toward separation science, Process Analytical Technologies (PAT) for process understanding and process control, structure elucidation and solid-state characterization
- Knowledge of analytical method development and testing requirements toward solid oral dosage support (immediate and controlled release solid dosage forms, liquid formulation or lyophilized formulation), including dissolution method development.
- Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner
- Hands on experience in development, validation, transfer and remediation of methods for in-process, release and stability testing
- Knowledge of the major Pharmacopeia and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) guidance documents related to analytical method transfer and validation, impurities, genotoxic impurities, early phase development.
- Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations
- Ability to multitask managing deliverables on complex projects against timelines
- Strong leadership, problem solving, decision making and communication skills with the ability to work cross-functionally and globally within CMC teams to deliver results
- Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
- A 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 plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
