Career CategoryOperations
Job DescriptionPost Doctoral Fellow What you will doLet's do this. Let's change the world. In this vital role Amgen is seeking a highly motivated Process Development Postdoctoral Fellow to join the Drug Product Technologies organization. The Fellow will lead an innovative research project focused on enabling high concentration biologic drug products through particle engineering and suspension based formulation and fill/finish approaches. The Drug Product Technologies group is responsible for phase appropriate drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), antibody drug conjugates (ADC's) and fusion proteins).
- Design and execute studies to develop high concentration protein formulations by evaluating viscosity reducing excipients and formulation strategies to enhance product performance and delivery
- Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g. UF/DF, spray drying, mixing, stability)
- Evaluate product and process performance through analytical testing (e.g. SEC, CEX-U/HPLC, particle analysis, moisture content)
- Apply solid-state (SEM, DSC, DVS) methods to establish relationships among formulation composition, particle structure, stability, and product performance
- Perform rheological characterization of high concentration formulations and suspensions
- Develop and evaluate concentrated protein suspension formulations for parenteral delivery, including assessment of device compatibility
- Build a wide range of data and analytics solutions, from available commercial dashboarding tools such as TIBCO Spotfire, MS Smartsheet
- Perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)
- Author/review/data verify technical protocols and reports.
- Participate in team meetings by sharing study results and technical challenges.
- Adapt to flexible working hours to accommodate project needs and team collaboration.
- Navigate and thrive in an environment with ambiguity, demonstrating adaptability and problem-solving skills.
- Work effectively across different time zones and be respectful of diverse cultures.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications:PhD at time of appointment
Preferred Qualifications:- Familiarity with pharmaceutical/biotechnology process development
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies
- Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)
- Experience developing spray dried particles or microparticles containing proteins, peptides, biologics, or other complex pharmaceutical modalities.
- Understanding of physical/chemical stability of proteins and how process related stresses impact molecule attributes and product quality
- Experience developing concentrated protein suspension formulations for prefilled syringe applications, including syringe compatibility testing, break-loose force extrusion force, injectability, and dose delivery performance
- Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
- Experience with programming (e.g. Python, R, MATLAB), database languages (e.g. SQL), data analytics, data modeling as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
- Self-motivation, adaptability and a positive attitude
- Critical thinking, problem solving and independent research skills
- Good organizational skills with strong attention to detail
- Excellent communication (oral and written)
What you can expect from 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.
