Bioassay Researcher

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Travel Required:

Clearance Required:

Our federal client conducts mission-relevant laboratory research to support science- and risk-based quality assessments of regulatory submissions standards development guidance creation policy development and pharmaceutical quality surveillance. This position will provide scientific and laboratory research support for approved bioassay projects focused on establishing characterizing optimizing and validating cell-based and biochemical assays for biological therapeutics.

The researcher will support laboratory-based experiments to advance bioassay development and characterization including transcytosis and permeation assays for evaluating the deposition and transport of biological therapeutics.

What You Will Do:

• Provide scientific and laboratory research support to establish characterize optimize and validate bioassays for biological therapeutics.

• Culture and maintain mammalian and immortalized cell lines using aseptic laboratory techniques.

• Develop and optimize cell-based transcytosis and permeation bioassays to evaluate transport of biological therapeutics across epithelial cell layers.

• Validate established bioassays against defined performance criteria including reproducibility sensitivity and specificity.

• Perform laboratory techniques including cell culture qRT-PCR ELISA western blotting immunohistochemistry and other biochemical or molecular assays.

• Conduct surveillance testing and investigate mechanisms of action of therapeutic proteins and peptides to identify relevant assay readouts.

• Establish new analytical methods to evaluate the biological activity of biotechnology products biosimilars and complex generics.

• Collect process analyze and document laboratory data from multiple sources and databases in accordance with project plans.

• Maintain complete and accurate laboratory notebooks experimental records methods and analyses in accordance with FDA laboratory standards.

• Assist with laboratory inventory management procurement equipment maintenance and instrument upkeep.

• Prepare technical reports scientific manuscripts status reports presentations and final project summaries supporting regulatory decision-making.

• Participate in interdisciplinary scientific collaborations and support OPQR-approved research projects.

• Provide weekly program updates and monthly project status reports detailing research findings milestone progress risks and issues.

• Attend relevant scientific laboratory programmatic and organizational meetings in support of project execution.

• Communicate complex scientific findings and project updates to both technical and non-technical stakeholders.

• Complete all required corporate and client training and maintain necessary credentials

What You Will Need:

• Masters degree in Chemistry Biology Biochemistry Cell Biology Bioengineering Pharmaceutical Sciences or a related scientific discipline.

• Three to six (36) years of experience developing optimizing validating or implementing bioassays for therapeutic proteins peptides biotechnology products biosimilars or complex generics.

• Experience with laboratory techniques such as qRT-PCR ELISA western blotting immunohistochemistry or related analytical methods.

• Experience collecting processing analyzing and documenting laboratory data in accordance with project plans and quality standards.

• Experience preparing scientific manuscripts technical reports presentations and research summaries.

• Knowledge of Good Laboratory Practices (GLP) ISO laboratory standards or equivalent laboratory quality systems.

• Strong oral and written communication skills with the ability to engage scientific programmatic and regulatory stakeholders.

• Understanding of regulatory interpretations product efficacy and safety considerations project plans and timelines.

• Ability to work effectively within interdisciplinary scientific teams in a laboratory research environment.

What Would Be Nice To Have:

• Ph.D. in Chemistry Biotechnology Biology Biochemistry Cell Biology Bioengineering Pharmaceutical Sciences or a related scientific discipline.

• Experience developing potency functional or mechanism-of-action bioassays for biologics biosimilars biotechnology products or complex generics.

• Experience with air-liquid interface cultures epithelial cell models transcytosis assays permeability assays or related in vitro transport models.

• Understanding of biopharmaceutical manufacturing process development biotechnology research and regulatory operations.

• Knowledge of insulin and GLP-1 receptor signaling pathways or related biological systems.

• Experience preparing peer-reviewed publications scientific posters regulatory science reports or white papers.

What We Offer:

Guidehouse offers a comprehensive total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

• Medical Rx Dental & Vision Insurance

• Personal and Family Sick Time & Company Paid Holidays

• Parental Leave

• 401(k) Retirement Plan

• Group Term Life and Travel Assistance

• Voluntary Life and AD&D Insurance

• Health Savings Account Health Care & Dependent Care Flexible Spending Accounts

• Transit and Parking Commuter Benefits

• Short-Term & Long-Term Disability

• Tuition Reimbursement Personal Development Certifications & Learning Opportunities

• Employee Referral Program

• Corporate Sponsored Events & Community Outreach

• annual membership

• Employee Assistance Program

• Supplemental Benefits via Corestream (Critical Care Hospital Indemnity Accident Insurance Legal Assistance and ID theft protection etc.)

• Position may be eligible for a discretionary variable incentive bonus

About Guidehouse

Guidehouse is an Equal Opportunity EmployerProtected Veterans Individuals with Disabilities or any other basis protected by law ordinance or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities or to apply for a position and you require an accommodation please contact Guidehouse Recruiting at 1- or via email at . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @ or . Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.

If any person or organization demands money related to a job opportunity with Guidehouse please report the matter to Guidehouses Ethics Hotline. If you want to check the validity of correspondence you have received please contact . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicants dealings with unauthorized third parties.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.