Analytical Development Scientist (HPLC)

Work Schedule

Environmental Conditions

Job Description

Do you have a passion for innovative ideas and groundbreaking discoveries With over $1 billion invested annually in R&D at Thermo Fisher Scientific youll help solve some of the worlds toughest challenges from giving cancer patients hope ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy resources and tools they need to take science a step beyond.

Location: On-site Bedford MA. Relocation assistance is NOT provided.

• Must be legally authorized to work in the United States withoutsponsorship.
• Must be able to pass a comprehensive background check whichincludes a drug screening.

Discover Impactful Work:

We are seeking an innovative and highly motivated Analytical Development Scientist to join our R&D this role you will contribute to the development and commercialization of next-generation analytical technologies with a primary focus on HPLC products and processes supporting critical to quality attributes in the biotechnology and biopharmaceutical industries.

You will work in a collaborative cross-functional environment to develop robust products characterize product performance and accelerate new product introductions that address critical customer needs. Experience or familiarity with analytical chromatography product development is highly desirable.

Key Responsibilities:

• Develop optimize and apply analytical HPLC methods to characterize product performance and support new product development.
• Design and execute experiments to evaluate product attributes relevant to regulated bioprocessing biologics development and drug-quality monitoring.
• Develop analytical strategies to assess critical-to-quality attributes including purity aggregation charge variants identity concentration or other relevant product and process attributes.
• Generate analyze and interpret complex analytical datasets to guide technical decisions product requirements and development strategy.
• Evaluate HPLC product performance across relevant use conditions sample types workflows and customer applications.
• Support product development activities including feasibility studies prototype evaluation design verification process optimization technology transfer and commercialization.
• Collaborate closely with Product Management Applications Manufacturing Quality Regulatory Commercial and other R&D teams throughout the product lifecycle.
• Support method transfer manufacturing validation and new product introduction activities through robust experimentation and clear documentation.
• Author technical reports protocols SOPs test methods presentations and other scientific documentation.
• Identify technical risks troubleshoot analytical challenges and adapt experiments based on emerging data.
• Contribute to innovation initiatives by identifying new applications technologies customer needs and product opportunities.
• Present technical findings and recommendations to internal stakeholders and when appropriate external customers.

How You Will Get Here:

Minimum Qualifications

• Ph.D. or M.S. with 3 years of experience in Analytical Chemistry Biochemistry Chemical Engineering Biotechnology Pharmaceutical Sciences or a related scientific field preferred; Bachelors with 5 years of experience in Analytical Chemistry Biochemistry Chemical Engineering Biotechnology Pharmaceutical Sciences or a related scientific field acceptable.
• Hands-on experience with analytical chromatography systems preferably HPLC or UHPLC.
• Strong understanding of analytical chromatography principles method development method optimization and data interpretation.
• Experience developing or applying analytical methods used to characterize biological molecules biopharmaceutical products or process-related attributes.
• Experience designing experiments analyzing analytical data troubleshooting methods and drawing technically sound conclusions.
• Demonstrated ability to work effectively in cross-functional technical teams.
• Strong technical writing documentation and communication skills.

Preferred Qualifications

• Experience in a regulated GMP-adjacent quality-control analytical development process development or biopharmaceutical laboratory environment.
• Familiarity with analytical methods used to monitor critical-to-quality attributes in biologics or bioprocessing workflows.
• Experience with one or more analytical characterization techniques such as SEC ion exchange chromatography reversed-phase chromatography HIC affinity chromatography ELISA IC DLS UV-Vis CE or mass spectrometry.
• Familiarity with analytical method lifecycle concepts including method qualification validation transfer robustness precision accuracy specificity and system suitability.
• Knowledge of FDA ICH USP or other regulatory guidance related to drug quality analytical methods or biologics characterization.
• Experience with downstream purification bioprocessing biologics development chromatography media chromatography columns or analytical workflow development.
• Experience supporting technical transfer manufacturing validation product launch or customer-facing technical activities is a plus but direct product development experience is not required.
• Ability to identify issues troubleshoot experiments adapt quickly based on data and seek input when needed.

What Were Looking For:

• Scientific curiosity and a passion for innovation.
• Strong analytical problem-solving and critical-thinking skills.
• Ability to manage multiple priorities in a fast-paced R&D environment.
• Collaborative mindset with strong interpersonal skills.
• Attention to detail and commitment to high-quality experimental execution.
• Customer-focused approach to product and method development.
• Comfort working with ambiguity and translating technical data into practical recommendations.
• Continuous-improvement mindset and willingness to learn new technologies applications and workflows.

We offer competitive remuneration annual incentive plan bonus scheme healthcare company 401k and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform critical job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

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