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Bioanalysis Director information

What does a bioanalysis director do?

A Bioanalysis Director oversees the design, implementation, and management of bioanalytical studies, typically within pharmaceutical or biotechnology organizations. They ensure that laboratory operations comply with regulatory standards and that analytical methods for measuring drugs, metabolites, or biomarkers are validated and reliable. Responsibilities also include managing scientific teams, coordinating with other departments, and representing bioanalytical interests in project meetings. Ultimately, they play a key role in ensuring the integrity and quality of data used in drug development.

What is the difference between Bioanalysis Director vs Bioanalytical Scientist?

AspectBioanalysis DirectorBioanalytical Scientist
Required credentialsAdvanced degree (PhD or MS), leadership experienceBachelor's or Master's in life sciences, specialized training
Work environmentManagement, strategic planning, overseeing teamsLaboratory research, method development, data analysis
Employer usagePharmaceutical, biotech companies, CROsResearch labs, biotech firms, CROs
Search intentLeadership roles, management, strategic oversightTechnical skills, laboratory work, data generation

The Bioanalysis Director typically oversees the entire bioanalytical department, focusing on strategy and management, while the Bioanalytical Scientist conducts hands-on laboratory research and method development. Both roles are essential in the bioanalysis field but differ in responsibilities and seniority.

What are some common challenges faced by a bioanalysis director when leading cross-functional teams in pharmaceutical research?

A Bioanalysis Director often encounters challenges related to coordinating efforts across multidisciplinary teams, such as scientists, project managers, and regulatory specialists. Ensuring clear communication, alignment on project timelines, and compliance with regulatory standards can be complex, especially in fast-paced environments. Additionally, balancing resource allocation and adapting to shifting scientific priorities requires strong leadership and strategic planning. Overcoming these challenges is key to delivering high-quality analytical data that supports drug development milestones.

What are the key skills and qualifications needed to thrive as a bioanalysis director?

A Bioanalysis Director should possess an advanced degree in life sciences, extensive experience in bioanalytical method development, and a strong understanding of regulatory guidelines such as GLP and GCP. Familiarity with analytical instruments like LC-MS/MS, LIMS, and relevant certifications (e.g., ASCP or equivalent) are commonly required. Strong leadership, project management, and communication skills are essential for coordinating teams and collaborating with stakeholders. These competencies ensure scientific rigor, regulatory compliance, and efficient delivery of high-quality data in bioanalytical studies.
What are popular job titles related to Bioanalysis Director jobs in New York? For Bioanalysis Director jobs in New York, the most frequently searched job titles are:
What job categories do people searching Bioanalysis Director jobs in New York look for? The top searched job categories for Bioanalysis Director jobs in New York are:
Bioanalysis Director jobs near you

Sr Technician, Bioanalytical

Kelly Services

Somerset, NJ

$30 - $40/hr

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 8 days ago

Job description

Sr Technician, Bioanalytical 

Kelly Outsourcing Consulting Group (Kelly OCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Sr Technician, Bioanalytical for a long-term engagement at one of our global pharmaceutical clients in Somerset, NJ. 

Schedule:  Monday–Friday, 1st shift 

Location:  Somerset, NJ 

Compensation:  $30.00–$40.00 per hour 

SUMMARY 

The Senior Technician performs all tasks a Technician can perform, with a primary focus on bioanalysis, method development support, and validation studies. Working within established regulated frameworks and under the scientific direction of an (Associate) Scientist, the Senior Technician executes assigned work independently, troubleshoots methods hands-on, and contributes to method development, optimization, and validation. The role also coordinates and coaches technicians, and is recognized as a practical problem solver with extensive knowledge of company processes. 

RESPONSIBILITIES 

Method development & validation (primary focus) 

  • Executes and supports bioanalytical method development, transfer, optimization, and validation activities within GLP/GxP and ICH M10 frameworks, under the scientific direction of an (Associate) Scientist. 

  • Performs hands-on troubleshooting of bioanalytical methods (e.g., LC-MS/MS), identifying root causes and implementing corrective actions to ensure robustness, accuracy, and reproducibility of study results. 

  • Coordinates the execution of a bioanalysis or validation study end-to-end, ensuring runs meet acceptance criteria and documentation standards. 

  • Applies a solid working knowledge of validation principles — selectivity, accuracy and precision, calibration range, stability, and carryover — to daily work, and can identify and resolve issues within bioanalytical and validation processes. 

Operations & compliance 

  • Performs all tasks and responsibilities of a Technician (STYR 4). 

  • Can serve as System Manager for laboratory equipment and support the implementation and qualification of new equipment. 

  • Maintains high standards across all deliverables, with strong attention to detail and full regulatory compliance and reliability. 

  • Effectively prioritizes tasks and meets deadlines under pressure; adapts quickly to changing priorities, new technologies, and evolving project requirements. 

  • Capable of organizing activities to meet project goals. 

People & knowledge 

  • Trains new employees and can mentor an MBO intern. 

  • Provides guidance and support to colleagues and shares knowledge and complex concepts effectively. 

QUALIFICATIONS 

  • Higher professional or master's-level laboratory education (HBO / MSc) — or an equivalent US laboratory-science degree (BS/MS in chemistry, biochemistry, analytical or pharmaceutical sciences, or a related field). 

  • 1–3 years of relevant experience in a regulated environment (GLP/GxP preferred), including direct, hands-on involvement in bioanalytical method development and/or validation. 

  • Hands-on LC-MS/MS experience for the bioanalysis of small molecules and/or large molecules (experience with both strongly preferred), including method development, optimization, and troubleshooting. 

  • Working familiarity with bioanalytical method validation requirements (ICH M10 / FDA / EMA) and the ability to execute validation runs to defined acceptance criteria. 

  • Fluent in English (verbal and written). Dutch is a plus. 

  • Proficiency in Microsoft Office (Word, Excel, Outlook). 

P#1 


As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.