Sr Scientist Bioanalytical Sciences
Sr Scientist Bioanalytical Sciences
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Salary Not Disclosed
1 Vacancy
Job Description
Biogens West Coast Hub based in South San Francisco is specifically focused on transforming the lives of patients with severe immunemediated diseases by developing novel targeted therapies with outsized clinical impact faster. To accomplish this we are seeking top talent to join us on our journey.
About This Role
The Sr. Scientist will be responsible for developing optimizing and validating biomarker and bioanalytical assays in clinical and nonclinical studies and will be responsible for managing external bioanalytical CROs. This position will report into the Bioanalytical Sciences and Operations West Coast Hub Lead.
What Youll Do
- Serve as the technical lead for PK ADA and biomarker assay development and optimization efforts providing handson expertise in MSD Ella ELISA and other immunoassay platforms.
- Lead the transfer and validation of assays at CROs and clinical laboratories ensuring compliance with GLP/GCLP and clinical study requirements.
- Function as the primary scientific and technical point of contact for external vendors overseeing assay transfers work plans timelines data quality and deliverables.
- Provide scientific oversight in method feasibility assessments and troubleshooting to drive highquality data generation.
- Review and approve key bioanalytical and biomarker assayrelated documents including SOWs validation reports SOPs SAPs and DTAs.
- Collaborate with clinical biomarkers clinical operations clinical pharmacology biometrics and regulatory teams to ensure seamless integration of biomarker strategies into clinical studies.
- Monitor and interpret biomarker and bioanalytical data providing scientific and technical insights to guide decisionmaking.
- Stay current with emerging biomarker technologies and regulatory guidelines to inform assay development strategies.
Who You Are
You are a scientifically driven detailoriented biomarker scientist with handson experience in bioanalytical and immunoassay development and validation. You thrive in a collaborative environment enjoy solving complex problems and have a track record of working effectively with vendors and CROs. Youre comfortable working with clinical samples and are passionate about generating highquality data to support drug development.
Qualifications :
Required Skills:
- MS with 4 years of experience or BS with 6 years of experience in bioanalytical and/or biomarker assay development and in clinical trials.
- Strong laboratory background with proficiency in several biological techniques (ELISA ECL etc. and their associated software.
- Experience with immunoassay platforms such as ELISA (SpectraMax) MSD (Meso Scale Discovery) and ELLA (Protein Simple).
- Extensive experience in technical development validation and implementation bioanalytical (PK and ADA) and biomarker assays for clinical studies.
- Strong scientific problemsolving and data interpretation skills.
- Excellent organization written and verbal communication skills.
- Project management skills to meet critical timelines associated with various activities necessary to support the assessment of clinical samples
Preferred Skills
- PhD with 2 years of experience
- Experience working with external partners such as CROs and vendors to support outsourced activities.
- Additional expertise in platforms like Simoa (Quanterix) Singulex (Erenna) Olink and Somalogic is a plus.
Additional Information :
The base compensation range for this role is $. Base salary offered is determined though an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity. Regular employees are eligible to receive both short term and longterm incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social wellbeing; including but not limited to:
Medical Dental Vision & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short and LongTerm Disability insurance
A minimum of 15 days of paid vacation and an additional endofyear shutdown time off (Dec 26Dec 31
Up to 12 company paid holidays 3 days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10000 per calendar year
Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
