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Bioanalysis Director Jobs in Texas (NOW HIRING)

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, and why are they important?

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 Texas? For Bioanalysis Director jobs in Texas, the most frequently searched job titles are:
Senior Director, Scientific Affairs

Senior Director, Scientific Affairs

Round Rock High School

Round Rock, TX • On-site

$175K - $240K/yr

Full-time

Re-posted 6 days ago


Round Rock Independent School District rating

8.5

Company rating: 8.5 out of 10

Based on 14 frontline employees who took The Breakroom Quiz

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Job description

Job Title: Sr. Director, Scientific Affairs
Department: Research & Development
Location: Rochester, NY | Relocation Package Available
Hours Per Week: 40
Schedule: Days, Monday - Friday
SUMMARY
This role provides strategic scientific leadership to advance ACM's long-term vision, translating organizational strategy into high-impact scientific execution across global teams of scientists, PhDs, and R&D professionals. Serving as the internal and external scientific ambassador for ACM, the role partners closely with senior leadership, clients, and industry stakeholders to identify gaps, develop innovative scientific solutions, and strengthen service offerings. With global responsibility for scientific leadership, this position drives continuous improvement, ensures scientific rigor and quality, and aligns evolving capabilities with the demands of clinical trials and emerging therapeutic areas.
RESPONSIBILITIES
  • Partner with VP Clinical operations to identify and operationalize scientific strategy
  • Responsible for the performance of the scientific teams by managing resources, prioritizing tasks, and developing and monitoring metrics.
  • Promote and uphold a high performing culture through effective talent planning, selection, onboarding, and continuing education.
  • Curate and deliver comprehensive training plans and materials to foster successful onboarding and employee performance.
  • Provide ongoing coaching and mentorship supported by routine performance metrics to identify clear performance feedback and career development plans.
  • Foster professional development through continuous coaching and performance management
  • Oversee Principal Scientists and works with key operational and regulatory leadership for strategic initiatives including new biomarkers and technologies.
  • Oversee and manage the R&D team to assign resource in line with required validations and laboratory support of safety testing.
  • Collaborates with VP, Clinical Operations to create plans for conference attendance and external marketing.
  • Serve as the point of escalation to provide scientific solutions as required for internal teams and external clients.
  • Identify, lead, and/or participate in cross functional process improvement initiatives to optimize capabilities.
  • Coordinates the development of 3PL and Client strategy and attends meetings as appropriate.
  • Assign Principal Scientist team to support non-safety testing aspects to expand service offerings and provide scientific expertise for 3PL assignment and regulatory audits.
  • Assign R&D team to support safety testing to expand service offering and provide expertise for client and 3PL safety enquiries.
  • Oversee and help resolve internal and external audit findings.
  • Perform other duties as needed.

REQUIRED QUALIFICATIONS
  • PhD + 10 years in Clinical Trials regulatory laboratory or BS in Life Sciences + 15 years in Clinical Trials regulatory laboratory experience
  • 5 years of progressive leadership experience

PREFERRED QUALIFICATIONS
  • NYS Certification of Qualification through New York State Department of Health, Wadsworth Center in: Clinical Chemistry, Diagnostic Immunology, Endocrinology, and/or Hematology
  • Understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), NYSH and UK EMEA
  • Application of science in a regulatory environment including validation of methodologies for clinical trials.
  • Experience leading teams, projects, and troubleshooting essential
  • Board Certification in one of the following areas is preferred:
  • ABB - American Board of Bioanalysis
  • ABCC - American Board of Clinical Chemistry
  • ABFT - American Board of Forensic Toxicology (limited to individuals with a doctoral degree)
  • ABHI - American Board of Histocompatibility and Immunogenetics
  • ABMGG - American Board of Medical Genetics and Genomics (formerly known as American Board of Medical Genetics (ABMG))
  • ABMLI - American Board of Medical Laboratory Immunology
  • ABMM - American Board of Medical Microbiology
  • NRCC - National Registry of Certified Chemists (limited to individuals with a doctoral degree

EDUCATION:
LICENSES / CERTIFICATIONS:
PHYSICAL REQUIREMENTS:
S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.
Any physical requirements reported by a prospective employee and/or employee's physician or delegate will be considered for accommodations.
PAY RANGE:
$175,000.00 - $240,000.00
CITY:
Rochester
POSTAL CODE:
14624
The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.

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