GCP Bioanalysis Senior Scientist

Novartis Group Companies; Cambridge (MA); On-site; USD 85,000 - 159,000; Full time

Job summary

An established industry player is seeking a Senior Scientist to join their Translational Medicine Drug Disposition Bioanalytical group. In this pivotal role, you will leverage your expertise in bioanalytics to develop and validate assays, ensuring the highest standards in clinical sample analysis. Your contributions will directly impact patient care, making this an exciting opportunity for those passionate about advancing medical science. Collaborate with a talented team and embrace the chance to grow your skills while working on innovative biologics. Join a mission-driven organization committed to improving lives through cutting-edge research.

Benefits

Medical Benefits

Retirement Plan

Paid Time Off

Stock Units

Qualifications

• 3+ years of regulated lab experience for Senior Scientist I.
• Strong laboratory skills with proficiency in biological techniques.

Responsibilities

• Designing, developing, and validating assays for clinical samples.
• Conducting lab activities and maintaining data records.

Skills

Bioanalytical Techniques

ELISA

ECL

Gyrolab

Data Analysis

Project Management

Education

Bachelor's in Biological Sciences

Tools

LIMS Systems

Job description

Job Description Summary

Onsite: Cambridge, MA
Internal job title: Senior Scientist I or II

Are you looking to build and grow your scientific toolbox and gain hands-on experience with novel modalities? As a Senior Scientist in the Translational Medicine Drug Disposition Bioanalytical group, you will have the opportunity to make a difference. If you have a collaborative nature, a commitment to teamwork across an organization, and a relentless focus on improving patient care, we want you to apply.

In the Senior Scientist role, you will use your knowledge of bioanalytics and lab/instrument skills to develop, validate, and analyze clinical samples, focusing on our novel modality biologics portfolio.

Job Description

To conduct bioanalysis in a regulated GCP lab:

Your main responsibilities will include but are not limited to:

1. Independently designing, developing, and validating assays, and performing sample analysis using biological techniques for PK, PD, and immunogenicity following SOPs and guidelines.
2. Being responsible for all assigned study/lab/project activities and providing input to bioanalytical strategies.
3. Data processing, evaluating results, interpreting data, and drawing relevant conclusions. Critically analyzing data on study and project levels.
4. Conducting lab activities and maintaining timely raw data records in accordance with company and health authority guidelines.
5. Preparing study protocols, reports, and contributing to health authority documents.
6. Maintaining high competence on routinely used laboratory equipment and LIMS systems. Evaluating and setting up new technologies as they are introduced to the lab.
7. Contributing to the general lab environment, including instrument maintenance, writing/updating templates and SOPs, software validation activities, ordering supplies, etc.
8. Coaching and mentoring in a matrix team environment.

What you bring to the role:

1. College/university degree in biological sciences or equivalent (e.g., Bachelors), with 3+ years of relevant regulated lab experience for Senior Scientist I and 5+ years for Senior Scientist II.
2. One year experience in regulated biologics bioanalysis for Senior Scientist I or 2 years for Senior Scientist II.
3. Strong laboratory skills with proficiency in biological techniques (ELISA, ECL, Gyrolab, etc.) and their software.
4. Ability to work with minimal supervision and organize work across multiple projects to meet deadlines.
5. Eagerness to take on additional responsibilities; flexibility to adapt to changing priorities and strategies.
6. A collaborative spirit and willingness to mentor/coach peers.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $85,600 - $158,400 for Senior Scientist I and $93,000 - $174,000 for Senior Scientist II. Final pay will depend on various factors including location, experience, and skills. The total package may include bonuses, stock units, and benefits such as medical, retirement, paid time off, etc.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and Reasonable Accommodations

The Novartis Group of Companies are committed to providing reasonable accommodations to individuals with disabilities. If needed, contact us at [e-mail] or call [phone] with your request and contact information, including the job requisition number.