Process Development Senior Principal Scientist Bioconjugates

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 190,000 - 250,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Flexible work models

Retirement and savings plan

Job summary

Amgen, located at the Thousand Oaks campus in California, seeks a Senior Principal Scientist in Bioconjugates to lead a diverse team and drive sustainable manufacturing processes for ADCs. You will guide process development, mentor staff, and advance technology from early to late-stage development.

The role requires deep expertise in bioconjugation, cGMP, and regulatory interactions, with a proven record of leadership and scientific innovation in pharma.

Qualifications

• PhD/PharmD/MD with relevant post-doc experience and 3+ years in science.
• Masters with 6+ years in pharma or related field.
• Bachelor’s with 8+ years scientific experience.

Responsibilities

• Lead a multidisciplinary team for bioconjugate manufacturing at all stages of clinical development.
• Drive bioconjugation technology innovation and process improvements.
• Support cGMP manufacturing and technology transfer to GMP facilities.
• Develop strategies for process understanding, modeling, and characterization.
• Ensure timely delivery of project milestones and regulatory documents.
• Serve as technical expert and mentor staff in bioconjugation.
• Collaborate cross-functionally to advance regulatory filings.

Skills

Bioconjugation process development

People leadership

Regulatory knowledge

Cross-functional collaboration

Industrialization of bioconjugation

Education

PhD

PharmD

MD

Masters

Bachelor's

Tools

Bioconjugation techniques

ADC/HPAPI linker-payload synthesis

cGMP manufacturing

CMO tech transfer

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 career.

Process Development Senior Principal Scientist Bioconjugates

What you will do

Lets do this. Lets change the world. In this vital role you will join Amgens DSTS group within Process Development (PD) is responsible for the invention, development, and implementation of drug substance manufacturing processes and technologies to advance Amgen's exciting portfolio of synthetic and hybrid assets. Process chemists within our team apply their training to invent synthetic routes and chemical processes to support drug substance manufacturing from early to late-stage development.

Amgen is currently seeking a talented Senior Principal Scientist who will lead a multidisciplinary team of chemists and chemical engineers in the development of efficient and sustainable manufacturing processes for bioconjugates, including antibody drug conjugates (ADCs), drive technology innovation, provide technical expertise, and develop and mentor staff within the organization. The successful candidate for this role will be a people-centered leader with deep expertise in bioconjugation process development and industrialization of bioconjugation manufacturing processes with a proven track record of scientific innovation and leadership within the pharmaceutical industry. The role will be located atour Thousand Oaks, California campus.

• Lead a multidisciplinary project team in the development of sustainable and cost-effective processes for bioconjugate manufacturing at all stages of clinical development
• Drive bioconjugation technology innovation
• Support cGMP manufacturing and technology transfer to GMP production facilities
• Develop strategies to ensure process performance through process understanding, modeling and characterization
• Guide successful completion of project deliverables and ensure timelines are met
• Work cross-functionally to deliver regulatory documents and support regulatory filings
• Serve as a technical expert and keep current in the field of bioconjugation manufacturing
• Coach and provide career and scientific / technical advice to colleagues within the organization

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 leader with these qualifications.

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 3 years of Scientific experience
  OR
• Masters degree and 6 years of Scientific experience
  OR
• Bachelors degree and 8 years of Scientific experience

Preferred Qualifications:

• Doctoral degree and 5+ years in the pharmaceutical industry with expertise in bioconjugate process development, preferably in Antibody Drug Conjugates (ADCs) with HPAPI linker-payload synthesis experience
• GMP manufacturing and technology transfer to CMOs
• Demonstrated functional representation on a CMC or PDT team
• Demonstrated ability to work within a dynamic and interdisciplinary environment to achieve results
• People-centered leadership skills in building strong teams through mutual trust and respect and exhibits Amgen leadership attributes of inspire, accelerate, integrate, and adapt
• Proven track record of publications, patents and presentations

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.

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.

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.

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.