Analytical Sr Scientist

Initial Therapeutics, Inc.; Cambridge (MA); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Comprehensive employee benefits

Annual bonus program

Flexible work models

Job summary

Initial Therapeutics, Inc. is looking for an Analytical Sr Scientist in Cambridge, Massachusetts. In this role, you will collaborate closely with a team of chemists to develop analytical tools essential for understanding manufacturing processes and products.

Your expertise in analytical techniques and experience in the pharmaceutical industry will be critical for defining strategies and managing projects at contract facilities. A supportive work environment and comprehensive benefits are part of our commitment to your professional growth and well-being.

Qualifications

• Doctorate degree (PhD, PharmD, or MD) and relevant post‑doctoral experience.
• Strong understanding of analytical method development in a pharmaceutical context.
• Experience in technical transfer for non‑GMP and GMP production.

Responsibilities

• Work closely with a team of analytical chemists and formulators.
• Manage activities at contract manufacturing and testing sites.
• Define analytical control strategies for clinical programs.

Skills

Analytical techniques (HPLC, UPLC)

Cross-functional leadership

Technical writing

Understanding of GLP and GMP

Small molecule analysis

Education

PhD in Analytical Chemistry or related field

Masters degree with 3 years of experience

Bachelors degree with 5 years of experience

Tools

Mass spectrometry

UV spectroscopy

NMR

FTIR

Job description

Analytical Sr Scientist

What you will do

In this vital role you will work closely with a team of analytical chemists, organic chemists and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for synthetic manufacturing processes and synthetic products.

• Integrate and successfully apply platform and prior product knowledge to advance Amgen practices and ensure success from first-in-human study through to marketing application.
• Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs.
• Collaborate closely with drug substance and drug product process development colleagues.
• Manage activities at contract manufacturing and testing sites.
• May lead and develop a small group of scientists.

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 a collaborative partner with these qualifications.

Basic Qualifications

• Doctorate degree (PhD, PharmD, or MD) and relevant post‑doctoral experience where applicable.
• Masters degree and 3 years of scientific experience.
• Bachelors degree and 5 years of scientific experience.

Preferred Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering.
• Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development is a plus.
• Strong understanding of small molecule analysis, structure elucidation and solid‑state characterization guided and informed by knowledge of organic chemistry.
• Experience in a wide variety of analytical techniques including chromatography (HPLC and UPLC), mass spectrometry, UV, NMR, FTIR, solid state characterization, etc.
• Developing and implementing methods for in‑process testing, release and stability testing. Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
• Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner.
• Experience in technical transfer for non‑GMP and GMP production and testing to external contract organizations, able to manage deliverables against timelines.
• Strong communication skills and ability to provide cross‑functional leadership and guidance to CMC and non‑clinical teams, e.g. informing and defending the Quality Target Product Profile.
• Works well in cross‑functional teams, and across various geographic locations in different time zones.
• Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents.

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 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:

• 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.

Equal Opportunity Employer

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.