Post Doctoral Fellow

Biopharma Careers; Cambridge (MA); On-site; USD 81,000 - 110,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

Amgen is seeking a Process Development Postdoctoral Fellow to join the Drug Product Technologies organization. Lead projects to enable high-concentration biologic drug products through particle engineering and suspension-based formulations, supporting fill/finish for monoclonal antibodies and related modalities.

The role requires a PhD and strong skills in formulation, analytical methods, and data analytics.

Qualifications

• PhD at time of appointment.
• Familiarity with pharmaceutical/biotechnology process development.
• Knowledge of Drug Product unit operations (ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and analytical techniques (SEC, CEX, HIAC, MFI).
• Experience developing spray dried particles or microparticles containing proteins or biologics.
• Programming experience (Python, R, MATLAB) and data analytics skills.
• Strong communication and problem-solving abilities.

Responsibilities

• Design and execute studies to develop high concentration protein formulations via excipient evaluation and strategies.
• Analyze data using statistics software (e.g. JMP, SAS) and document protocols and reports.
• Collaborate across teams to enable formulation and fill/finish processes for large molecule modalities.
• Develop data analytics solutions using dashboarding tools and communicate results to stakeholders.

Education

PhD in relevant field

Tools

Python

R

MATLAB

Tableau

Spotfire

Job description

Career Category

Operations

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission, to serve patients living with serious illnesses, drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Post Doctoral Fellow

What you will do

Let’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 you

We 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 us

As 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.

Application deadline

Amgen 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.

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity / Diversity

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 to 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Salary Range

81,178.40USD -109,829.60USD