Process Development Sr Scientist - Cambridge, MA

VetJobs; Cambridge (MA); On-site; USD 127,000 - 153,000; Full time

Job summary

A leading biotechnology company seeks a Process Development Sr Scientist in Cambridge, MA, to drive drug commercialization and develop innovative solutions for patients. Candidates should possess a degree in a related field and relevant industry experience. This position emphasizes collaboration and data-driven decision-making.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Flexible work models

Discretionary annual bonus program

Stock-based long-term incentives

Qualifications

• 5 years of Scientific experience or 3 years with a Master's degree.
• Experience in pharmaceutical development and biologics process development preferred.
• Ability to communicate effectively with cross-functional teams.

Responsibilities

• Lead drug product commercialization and lifecycle management.
• Design and document formulation and process development studies.
• Use data analytics to inform decisions on technical challenges.

Skills

Critical thinking

Problem solving

Independent research

Project management

Data analytics

Statistics

Education

Bachelor’s degree

Master’s degree

Doctorate degree

Tools

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

Data visualization tools (e.g., Tableau)

Programming languages (e.g., Python, R, MATLAB)

Job description

Process Development Sr Scientist - Cambridge, MA

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Process Development Sr Scientist - Cambridge, MA

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Job Description

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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. 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 Sr Scientist

What you will do

Responsibilities

Let’s do this. Let’s change the world. In this vital role you will provide technical and project leadership, 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 Amgen’s 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, implement, 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 stakeholders on progress towards milestones and forthcoming program needs.

Ability to travel domestically and internationally up to 10% of the time

Auto req ID

448240BR

Minimum Education Required

Bachelors

Job_Category

Scientific Research & Development

Additional Qualifications/Responsibilities

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

Bachelor’s degree and 5 years of Scientific experience; Or

Master’s degree and 3 years of Scientific experience; Or

Doctorate degree PhD OR PharmD OR MD

Preferred Qualifications

Advanced 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 co-formulations

Experience with advanced drug delivery, e.g. sustained release technologies, targeted delivery systems, microfluidics

Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), 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 one’s project resources (material, manpower, 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 from 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, including remote and hybrid work arrangements, where possible

Salary Range

127,764.00 USD - 152,656.00 USD

City*

Cambridge

State*

Massachusetts

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Amgen

Salary Range

>$100,000

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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