Sr Scientist

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health and welfare plans

Retirement and savings plan

Flexible work models

Comprehensive benefits package

Job summary

Join Initial Therapeutics, Inc. as a Sr Scientist in Thousand Oaks, California, where you will be integral to our Drug Product Technologies Group. In this role, you will lead process development for biologics, ensuring successful commercialization and lifecycle management of new products.

The position requires a strong background in drug formulation, experience with statistical techniques, and the ability to manage cross-functional projects effectively. A doctorate or equivalent experience is required.

Qualifications

• PhD or equivalent in engineering or scientific field.
• 3+ years of scientific experience for Master's holders.
• 5+ years of scientific experience for Bachelor's holders.

Responsibilities

• Participate in Drug Product Commercialization Teams.
• Design, plan, and document drug product development studies.
• Provide technical support for manufacturing operations.

Skills

Critical thinking

Problem-solving

Project management

Statistical analysis

Education

Doctorate degree (PhD, PharmD, MD)

Masters degree and 3 years of scientific experience

Bachelors degree and 5 years of scientific experience

Tools

Statistical software (e.g., SAS, JMP, Minitab)

AI-enabled tools

Data visualization tools (e.g., Tableau, Spotfire, D3js)

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your careerr.

Sr Scientist

What you will do

Lets do this. Lets change the world. In this vital role you will work in our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and process development for biologics modalities. The Scientist will provide technical and project support, integrating effective cross-functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgens pipeline.

The responsibilities of this candidate will include:

• Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
• Design, plan, complete, and document formulation and process development studies
• Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to solve technical challenges
• Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
• Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
• Effectively and consistently communicate with management, cross-functional partners and relevant team members on progress towards achievements and forthcoming program needs.
• Lead cross functional initiatives enhancing Pivotal Drug Product platforms
• Manage and contribute to process design improvement projects
• Ability to travel domestically and internationally up to 10% of the time

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
OR
Masters degree and 3 years of Scientific experience
OR
Bachelors degree and 5 years of Scientific experience

Preferred Qualifications:

• Degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Materials Science, Pharmaceutics or related field
• Experience in pharmaceutical development and manufacturing
• Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
• Experience with development and characterization of formulations and drug product manufacturing processes
• Experience with programming, application of AI-enabled tools as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
• Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
• Critical thinking, problem solving and independent research skills
• Strong project management skills, including the ability to manage ones project resources (material, workforce, time, etc.)
• Good organizational skills with strong attention to detail
• Strong ability to operate well in a fast-paced, matrixed environment and collaborate successfully cross-functionally

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, 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.

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.