Process Development Scientist

Amgen; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen in Cambridge, MA seeks a Process Development Scientist to join the Synthetics Enabling Technologies group. The role focuses on solid-state characterization, especially ssNMR, to support drug substance and drug product development for synthetics and biologics.

The position interfaces with Process Development and Research & Discovery to drive form development and transfer to manufacturing. The ideal candidate will have a strong background in ssNMR, solid-state analytics, and experience

Qualifications

• PhD or equivalent required; strong background in solid-state NMR is essential.
• Experience with solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption) is preferred.
• Ability to contribute to regulatory filings and IND/NDA support may be expected.

Responsibilities

• Explore and implement ssNMR techniques to enhance product development.
• Develop and apply innovative ssNMR approaches to solve complex problems.
• Provide solid-state characterization support to drug substance/product development for synthetics and biologics.
• Interface with Process Development and R&D teams to advance projects.
• Assist in training staff and presenting results at meetings.
• Build relationships with internal and external stakeholders.

Skills

ssNMR spectroscopy

Solid-state characterization

Drug substance development

Education

Doctorate degree

Master’s degree with 2 years of scientific experience

Bachelor’s degree with 4 years of scientific experience

Job description

• Experience in solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization, etc.) is desired

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.

Process Development Scientist

Let’s do this. Let’s change the world. In this vital role you will join Amgen’s Pre-Pivotal Drug Product Technologies organization, the Synthetics Enabling Technologies (SET) group in Cambridge, MA, is seeking a highly motivated and team-oriented individual for the position of Process Development Scientist. SET is a key Drug Product Technology interface with partners in Process Development and Research & Discovery. This individual will provide solid state characterization, with a strong focus on solid state NMR (ssNMR) spectroscopy, for drug substance and drug product process development for synthetics and biologics programs in support of SET’s key responsibilities which include:

• Utilize advanced solid-state characterization methods (e.g. ssNMR) to support drug substance and drug product process development for synthetics and biologics programs.


• Drive lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile).


• Perform synthetics molecule assessment (developability assessment) and preclinical formulation support.


• Perform biopharmaceutical assessments utilizing predictive in silico and in vitro models to identify development strategies.


• Provide early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and technical transfers to support clinical manufacturing (GMP).

This individual will carry out solid-state analysis and physicochemical characterization to aid solid form and formulation development of drug substances and drug products. The primary responsibilities will include developing, implementing, and applying advanced ssNMR techniques to characterize the structures and interactions of small and large drug molecules. The role will leverage these techniques to investigate and resolve complex scientific questions in pharmaceutical materials science.

Responsibilities:

• Explore and implement ssNMR techniques to enhance productivity, robustness and efficiency of small molecules and biologics development.


• Take a proactive role in developing and applying innovative ssNMR approaches, demonstrating creativity in solving complex technical problems, for example understanding excipient-drug interactions and quantitative analysis of heterogeneous mixtures.


• Provide solid state characterization support to biopharmaceutics assessment, form screening/selection, and drug substance and drug product process development for synthetics and biologics programs.


• Interface with partners in Process Development and Research and Development.


• Support departmental activities including training staff and presenting scientific results at internal/external meetings.


• Build and maintain strong working relationships with key stakeholders internally and externally.


• Contributes to regulatory filings including IND and NDA as needed and assists in answering questions from regulatory authorities. Contributes to Amgen’s intellectual property and patent filings

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications

• Doctorate degree


• OR


• Master’s degree and 2 years of Scientific experience


• OR


• Bachelor’s degree and 4 years of Scientific experience

Preferred Qualifications

• Master’s degree in one of the following areas: Physics, Materials Science, Pharmaceutical


• Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline


• Strong background in ssNMR spectroscopy method development and theory with a record of scientific presentations, such as, peer-reviewed publications


• Experience in ssNMR instrumentation, operation, and maintenance is beneficial


• Specific experience developing ssNMR methods to characterize small and large molecule drug substances and drug products, such as solid form analysis, impurity phase/amorphous content detection and physical stability assessment


• Experience in solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, particle characterization, etc.) is desired


• Working knowledge of solid form development such as polymorphism, solvates/hydrates and salt/co-crystal characterization is beneficial


• Good informatics skills and experience with molecular modelling calculations to study molecular interactions and simulate NMR experimental observables is beneficial


• Excellent written, verbal, and presentation skills - ability to distill, craft and present key


• messages relative to diverse audience requirements


• Problem solver with a proactive attitude and ability to collaborate and work in a cross-functional and multidisciplinary environment


• Abilities to take initiatives, work independently, and be flexible in responsibilities

What You Can Expect Of 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.

In 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 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. 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 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.