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Bioanalytical Project Manager Jobs in Washington

This includes managing sample analysis and validation projects, overseeing the analytical schedule in coordination with laboratory management, and providing guidance to bioanalytical testing staff ...

... bioanalytical projects. DUTIES AND RESPONSIBILITIES: * Perform sample analysis with minimal ... Proficiency in MS Office suite; familiarity with electronic file management using SharePoint (end ...

Exceptional project management and organizational skills. * Exceptional partnering and ... Be responsible for bioanalytical and assay methods development in molecular biology (DNA, RNA and ...

Exceptional project management and organizational skills. * Exceptional partnering and ... Be responsible for bioanalytical and assay methods development in molecular biology (DNA, RNA and ...

... project related support by creating study-specific documentation, assisting the Bioanalytical ... Manages study documentation for multiple concurrent, moderate to high complexity projects • ...

Scientist

Gaithersburg, MD · On-site

$92K - $138K/yr

Develop,qualify, and, whererequired,validatePK bioanalytical assaysfitfor purpose across discovery ... Proven ability to manage multiple studies in parallel, meet timelines, andmaintainmeticulous ...

... Bioanalytical separation. * Initiate, implement, plan, and execute scientific research and ... as project manager in the drafting of state-of-art work and publishing of papers. * Develop ...

... Bioanalytical separation. Initiate, implement, plan, and execute scientific research and ... project manager in the drafting of state-of-art work and publishing of papers. Develop research ...

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Bioanalytical Project Manager information

What does a Bioanalytical Project Manager do?

A Bioanalytical Project Manager oversees and coordinates bioanalytical studies, ensuring that projects are completed on time, within budget, and according to regulatory standards. They act as the main point of contact between clients, laboratory teams, and regulatory agencies, managing study timelines, resources, and data quality. Their responsibilities include planning project activities, monitoring progress, troubleshooting issues, and reporting results to stakeholders. They play a critical role in drug development by ensuring that bioanalytical testing meets scientific and compliance requirements.

What are the key skills and qualifications needed to thrive as a Bioanalytical Project Manager, and why are they important?

To thrive as a Bioanalytical Project Manager, you need a strong background in bioanalysis, project management experience, and typically a degree in life sciences or a related field. Familiarity with laboratory information management systems (LIMS), regulatory guidelines (such as GLP/GCP), and project management tools like MS Project is essential. Excellent communication, leadership, and organizational skills help manage cross-functional teams and client expectations. These skills ensure the successful planning, execution, and delivery of complex bioanalytical projects within regulatory and timeline constraints.

What are some common challenges faced by Bioanalytical Project Managers, and how can they be addressed?

Bioanalytical Project Managers often face challenges coordinating timelines across multiple stakeholders, such as laboratory teams, clients, and regulatory bodies. Managing shifting project priorities and ensuring data integrity under tight deadlines can also be demanding. To address these challenges, effective communication, proactive risk management, and strong organizational skills are essential. Regular status meetings, clear documentation, and building strong relationships with both internal and external partners help keep projects on track and ensure compliance with regulatory standards.

What is the difference between Bioanalytical Project Manager vs Bioanalytical Scientist?

AspectBioanalytical Project ManagerBioanalytical Scientist
CredentialsBachelor's or Master's in Life Sciences, PMP often preferredDegree in Biology, Chemistry, or related field; PhD or Master's common
Work EnvironmentProject teams, client meetings, coordination rolesLaboratory research, data analysis, method development
Employer & Industry UsagePharmaceutical, biotech companies, CROsResearch labs, pharmaceutical companies, CROs

The Bioanalytical Project Manager oversees project timelines, budgets, and client communication, ensuring successful completion. In contrast, the Bioanalytical Scientist focuses on experimental design, data collection, and method development. Both roles are essential in the bioanalytical industry but differ in responsibilities and daily tasks.

What cities in Washington are hiring for Bioanalytical Project Manager jobs? Cities in Washington with the most Bioanalytical Project Manager job openings:
Bioanalytical Scientist

Bioanalytical Scientist

MSD

Gaithersburg, MD • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 10 days ago


Job description

POSITION SUMMARY:
The Bioanalytical Scientist functions as a Bioanalytical Principal Investigator (BPI), providing technical guidance and expertise in executing sample analysis studies and analytical method validations. This includes managing sample analysis and validation projects, overseeing the analytical schedule in coordination with laboratory management, and providing guidance to bioanalytical testing staff and other team members as needed. This role will interact with customers to ensure the studies are managed under the appropriate regulatory scope, review study data, and conduct applicable data analysis as required by each project. This position may directly supervise the work of others.
DUTIES AND RESPONSIBILITIES:
  • Manage sample analysis and method validation projects performed in the Bioanalytical Laboratory utilizing appropriate protocols and in compliance with Good Laboratory Practice (GLP) and/or Good Clinical Laboratory Practice (GCLP) as required

    • Plan and oversee individual experiments as required for each project
    • Ensure resources (reagents, materials, equipment) are available and appropriate for intended use by laboratory staff
    • Review documentation associated with executed projects including data capture, forms, logbooks, and inventory batch records

  • Provide technical guidance to bioanalytical testing staff and other team members as needed in the execution of bioanalytical projects
  • Interpret, organize, and present study results as required for each project
  • Review lot qualification data
  • Monitor material inventory, project-specific materials in particular, to ensure no impediments in completing studies.
  • Draft appropriate study plans, reports, and documents
  • Review analytical reports for completeness and compliance with study requirements
  • Adhere to principles of GLP/GCLP applicable to bioanalytical sample testing, data analysis and reporting
  • Adhere to all laboratory safety policies and procedures including proper use of all required personal protective equipment (PPE); monitor the behavior of laboratory staff and proactively address departures from best practices for laboratory safety
  • If applicable, establish and monitor direct report performance and development goals, assign accountabilities, set objectives, and provide continuous feedback and recognition on performance
  • May be responsible for training and development of laboratory team

EXPERIENCE AND QUALIFICATIONS:
  • Ph.D. in Biology, Chemistry, or related scientific discipline preferred

    • Additional postdoctoral or industrial experience preferred
    • Master's degree may be considered with additional years of related experience
    • Bachelor's degree may be considered with additional years of experience including a minimum of 4 years of hands-on experience with the MSD platform

  • Minimum of 4 years of hands-on laboratory work experience is required; experience in biological sample testing is preferred; experience in a clinical research organization (CRO) or other regulated environment is highly preferred; academic setting considered
  • Experience with running immunoassays/ligand-binding assays is required
  • Experience with running assays on the MSD platform is highly preferred
  • Training in and experience with Biosafety Level 2 (BSL-2) techniques is required
  • Training in and experience with GLP and/or GCLP is required
  • Experience working in a high complexity/high throughput/fast-paced lab is required
  • Supervisory/management experience desired

KNOWLEDGE, SKILLS AND ABILITIES:
  • Strong understanding of ligand-binding assays
  • Strong scientific fundamentals and analytical background

    • Logical problem solving and demonstrated ability to initiate, organize and implement process improvement activities

  • Demonstrated ability to execute and oversee assays run in a fast-paced environment with a focus on high-quality results.
  • Demonstrated ability to troubleshoot complex issues and provide solutions to technical challenges.
  • Leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results.
  • Excellent interpersonal skills and ability to work well with employees at all levels

    • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
    • Effectively communicate performance goals and expectations

  • Proficient in MS Office suite; familiar with electronic file management using SharePoint (end user minimum)
  • Strong organizational, planning, and time management skills with the ability to manage multiple and often changing priorities and issues of varying complexity, while meeting time-sensitive deadlines and deliverables
  • Basic statistical knowledge

PHYSICAL DEMANDS:
  • Up to 20% of the day may be spent in the laboratory, and may involve repetitive tasks (e.g., pipetting)
  • Ability to lift/move up to 25 pounds

WORK ENVIRONMENT:
  • This position is performed in a laboratory environment up to 20% of the time, working with chemical reagents and Biosafety Level 2 materials including human blood/blood products and other potentially infectious human samples

    • May involve handling of pathogenic materials and organisms

  • Other assigned responsibilities will be performed in a traditional office environment

COMPENSATION SUMMARY:
The annual base salary for this position ranges from $101,400 to $154,700. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.
BENEFITS SUMMARY:
At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.
EEO/AA STATEMENT:
MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.
Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.