Process Development Senior Scientist – Drug Product Technologies

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Comprehensive employee benefits

Retirement and Savings Plan

Flexible work models

Job summary

Initial Therapeutics, Inc. seeks a Process Development Senior Scientist - Drug Product Technologies in Thousand Oaks, California. This role is crucial for the development of early-stage drug products, emphasizing antibody-drug conjugates (ADCs) and biologics.

The candidate will leverage advanced formulation techniques, collaborate across functions, and utilize AI/ML for innovation in drug development. A PhD in a relevant field and experience in formulation development are essential. Comprehensive benefits and a dynamic work environment await the successful applicant.

Qualifications

• PhD or equivalent in relevant field and strong background in drug product formulation.
• Experience in early-stage biologics development and related regulatory submissions.
• Ability to integrate formulation and analytical data for product advancement.

Responsibilities

• Design and develop formulations for biologics, focusing on ADCs.
• Plan and execute formulation process studies for early-stage programs.
• Present findings to internal and external stakeholders.

Skills

Formulation development

Stability testing

AI/ML application

Collaboration

Analytical techniques

Education

PhD in Pharmaceutics, Biotechnology, or related field

Masters degree

Bachelors degree

Tools

HPLC

AI tools

Job description

Process Development Senior Scientist - Drug Product Technologies

What you will do

Lets do this. Lets change the world. In this vital role you will join Pre-Pivotal Drug Product Technologies group, responsible for early-stage drug product development across diverse modalities, with a strong emphasis on antibody-drug conjugates (ADCs), as well as monoclonal antibodies,multispecificsandotherbiologicmodalities. The role involves designing and developing liquid and lyophilized formulations; evaluating critical quality attributes (CQAs);establishingrobust, scalable fill/finish processes for complex biologic drug products; and authoringand supportinghigh quality regulatory submissions.

The ideal candidate will bring hands‑on experience in ADC drug product formulation and drug product process development, including a mechanisticunderstanding of linker-payload attributes,stability/process‑relevant degradation pathways, and analytical strategies used to characterize ADCCQAs. This candidate will integrate formulation, analytical, and process data to guide product design,applycutting‑edge technologies (including AI/ML), and collaborate cross‑functionally to deliver high‑quality, stable, and manufacturable drug products for clinical development in a fast‑paced environment.

Key Responsibilities

• Work effectively in a fast‑paced, matrixed environment, collaborating across process development, research, regulatory, and manufacturing teams to advance programs and communicate technical recommendations to both scientific peers and leadership.
• Plan and execute formulation and fill/finish process studies for early‑stage programs.
• Develop and characterize liquidandlyophilizedformulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab‑scale sterile filling.
• Build process understanding across unit operations to support scalable drug productdevelopment.
• Evaluate in‑use compatibility and drug product stability under clinical conditions.
• Investigate ADC- and biologics‑relevant CQAs (e.g., aggregation, fragmentation, drug‑to‑antibody ratio, free payload, charge/size variants, subvisible particles, surface interactions) to inform formulation and processdesigndecisions.
• Leverage high‑throughput tools for formulation screening and processability assessments.
• Identifyand address technology gapsimpactingADC stability, linker-payload integrity, protein-excipient interactions, and process‑related stress responses.
• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision‑making.
• Ensure development approaches arephase‑appropriate,from discovery through clinical manufacturing.
• Author technical documents, control‑strategy inputs, risk assessments, IND/CTA regulatory sections, and tech transfer packages.
• Support internal and external technology transfer activities, including collaboration with CMOs/CDMOs, batch record review, process fit assessments, person‑in‑plant support, and troubleshooting during manufacturing campaigns.
• Present findings to internal/external stakeholders and participate in cross‑functional teams.

What we expect of you

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

Basic Qualifications

• Doctorate degree PhD OR PharmD OR MD [and relevant post‑doc where applicable]
• OR
• Masters degree and 3 years of Scientific experience
• OR
• Bachelors degree and 5 years of Scientific experience

Preferred Qualifications

• PhD in Pharmaceutics, Biotechnology, Biochemistry, or related field with 24 years of postdoc or industry experience.
• Proven experience in formulation development, stability testing, and fill/finish operations for biologics; direct ADC drug product formulation experience is strongly preferred.
• Demonstrated understanding of ADC drug product development considerations, including linker-payload stability, drug‑to‑antibody ratio, free drug or payloaddegradation, quality attributes, and product/process comparability.
• Experience integrating formulation, stability, and analytical data to advance ADC candidates from discovery or preclinical development into clinical manufacturing is highly desirable.
• Strong foundationin analytical and biophysical techniques relevant to ADCs and biologics (e.g., UPLC/HPLC, SEC, IEX, RP‑HPLC, HIC, CE‑SDS, subvisible particle analysis, etc.).
• Familiarity with clinical‑stage development, manufacturability, and risk‑based decision‑making.
• Experience applying AI/ML (e.g., LLMs, in silico tools) to streamline R&D andoptimizeperformance.
• Skilled communicator with experience contributing to regulatory submissions (CTAs, BLAs).

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 well 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.com

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.

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 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.